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Copyright © JCCA 2005 Chiropractic clinical practice guideline: evidence-based treatment of adult neck pain not due to whiplash Elizabeth Anderson-Peacock, Barrie, ON; See letter "CCA/CFCRB-CPG Guideline Development Committee. Chiropractic clinical practice guideline: evidence-based treatment of adult neck pain not due to whiplash. J Can Chiropr Assoc 2005 49(3):158–209. http://www.ccachiro.org/Client/cca/cca.nsf/web/CPG-sep-05?OpenDocument" in volume 51 on page 189.Abstract OBJECTIVE To provide an evidence-based clinical practice guideline for the chiropractic cervical treatment of adults with acute or chronic neck pain not due to whiplash. This is a considerable health concern considered to be a priority by stakeholders, and about which the scientific information was poorly organized. OPTIONS Cervical treatments: manipulation, mobilization, ischemic pressure, clinic- and home-based exercise, traction, education, low-power laser, massage, transcutaneous electrical nerve stimulation, pillows, pulsed electromagnetic therapy, and ultrasound. OUTCOMES The primary outcomes considered were improved (reduced and less intrusive) pain and improved (increased and easier) ranges of motion (ROM) of the adult cervical spine. EVIDENCE An “extraction” team recorded evidence from articles found by literature search teams using 4 separate literature searches, and rated it using a Table adapted from the Oxford Centre for Evidence-based Medicine. The searches were 1) Treatment; August, 2003, using MEDLINE, CINAHL, AMED, MANTIS, ICL, The Cochrane Library (includes CENTRAL), and EBSCO, identified 182 articles. 2) Risk management (adverse events); October, 2004, identified 230 articles and 2 texts. 3) Risk management (dissection); September, 2003, identified 79 articles. 4) Treatment update; a repeat of the treatment search for articles published between September, 2003 and November, 2004 inclusive identified 121 articles. VALUES To enable the search of the literature, the authors (Guidelines Development Committee [GDC]) regarded chiropractic treatment as including elements of “conservative” care in the search strategies, but not in the consideration of the range of chiropractic practice. Also, knowledge based only on clinical experience was considered less valid and reliable than good-caliber evidence, but where the caliber of the relevant evidence was low or it was non-existent, unpublished clinical experience was considered to be equivalent to, or better than the published evidence. REPORTED BENEFITS, HARMS AND COSTS The expected benefits from the recommendations include more rapid recovery from pain, impairment and disability (improved pain and ROM). The GDC identified evidence-based pain benefits from 10 unimodal treatments and more than 7 multimodal treatments. There were no pain benefits from magnets in necklaces, education or relaxation alone, occipital release alone, or head retraction-extension exercise combinations alone. The specificity of the studied treatments meant few studies could be generalized to more than a minority of patients. Adverse events were not addressed in most studies, but where they were, there were none or they were minor. The theoretic harm of vertebral artery dissection (VAD) was not reported, but an analysis suggested that 1 VAD may occur subsequent to 1 million cervical manipulations. Costs were not analyzed in this guideline, but it is the understanding of the GDC that recommendations limiting ineffective care and promoting a more rapid return of patients to full functional capacity will reduce patient costs, as well as increase patient safety and satisfaction. For simplicity, this version of the guideline includes primarily data synthesized across studies (evidence syntheses), whereas the technical and the interactive versions of this guideline (http://ccachiro.org/cpg) also include relevant data from individual studies (evidence extractions). RECOMMENDATIONS The GDC developed treatment, risk-management and research recommendations using the available evidence. Treatment recommendations addressing 13 treatment modalities revolved around a decision algorithm comprising diagnosis (or assessment leading to diagnosis), treatment and reassessment. Several specific variations of modalities of treatment were not recommended. For adverse events not associated with a treatment modality, but that occur in the clinical setting, there was evidence to recommend reconsideration of treatment options or referral to the appropriate health services. For adverse events associated with a treatment modality, but not a known or observable risk factor, there was evidence to recommend heightened vigilance when a relevant treatment is planned or administered. For adverse events associated with a treatment modality and predicted by an observable risk factor, there was evidence to recommend absolute contraindications, and requirements for treatment modality modification or caution to minimize harm and maximize benefit. For managing the theoretic risk of dissection, there was evidence to recommend a systematic risk-management approach. For managing the theoretic risk of stroke, there was support to recommend minimal rotation in administering any modality of upper-cervical spine treatment, and to recommend caution in treating a patient with hyperhomocysteinemia, although the evidence was especially ambiguous in both of these areas. Research recommendations addressed the poor caliber of many of the studies; the GDC concluded that the scientific base for chiropractic cervical treatment of neck pain was not of sufficient quality or scope to “cover” current chiropractic practice comprehensively, although this should not suggest other disciplines are more evidence-based. VALIDATION This guideline was authored by the 10 members of the GDC (Elizabeth Anderson-Peacock, Jean-Sébastien Blouin, Roland Bryans, Normand Danis, Andrea Furlan, Henri Marcoux, Brock Potter, Rick Ruegg, Janice Gross Stein, Eleanor White) based on the work of 3 literature search teams and an evidence extraction team, and in light of feedback from a commentator (Donald R Murphy), a 5-person review panel (Robert R Burton, Andrea Furlan, Richard Roy, Steven Silk, Roy Till), a 6-person Task Force (Grayden Bridge, H James Duncan, Wanda Lee MacPhee, Bruce Squires, Greg Stewart, Dean Wright), and 2 national profession-wide critiques of complete drafts. Two professional editors with extensive guidelines experience were contracted (Thor Eglington, Bruce P Squires). Key contributors to the guideline included individuals with specialties or expert knowledge in chiropractic, medicine, research processes, literature analysis processes, clinical practice guideline processes, protective association affairs, regulatory affairs, and the public interest. This guideline has been formally peer reviewed. Keywords: chiropractic, guideline, evidence-based, neck pain Résumé OBJECTIF Donner une ligne directrice de pratique clinique fondée sur des éléments probants pour le traitement chiropratique des douleurs cervicales chez des adultes victimes de cervicalgies chroniques qui ne sont pas dues à un coup de fouet cervical. Il s’agit d’une préoccupation médicale très importante, considere par les parties prenantes comme une priorité et pour laquelle les informations scientifiques étaient mal organisées. OPTIONS Traitements des douleurs cervicales : manipulation, mobilisation, pression ischémique, exercice en clinique et à la maison, éducation, laser de faible puissance, massage, neurostimulation transcutanée, oreillers, thérapie par champ électromagnétique pulsé et ultrason. RÉSULTATS Les critères de jugement principaux pris en compte étaient l’amélioration de la douleur (douleur atténuée et moins intrusive) et l’amélioration de l’amplitude de mouvement (ADM) de la colonne cervicale de l’adulte (meilleure amplitude et mouvements plus faciles). ÉLÉMENT PROBANT Une équipe d’« extraction » a enregistré des éléments probants provenant d’articles relevés par des équipes de recherche bibliographique ayant fait appel à quatre sources de recherche documentaire différentes. Ces articles ont été classés selon un tableau adapté du Oxford Centre for Evidence-based Medicine. Les recherches ont porté sur : 1) Le traitement; août 2003; sources utilisées : MEDLINE, CINAHL, AMED, MANTIS, ICL, The Cochrane Library (y compris CENTRAL) et EBSCO; 182 articles identifiés; 2) La gestion des risques (événements indésirables); octobre 2004; 230 articles et 2 textes identifiés; 3) La gestion des risques (dissection); septembre 2003; 79 articles identifiés; 4) La mise à jour des traitements; une répétition de la recherche bibliographique d’articles sur les traitements publiés entre septembre 2003 et novembre 2004; 121 articles identifiés en tout. ÉCHELLE DE VALEURS Pour favoriser la recherche bibliographique, les auteurs (le Comité d’élaboration des lignes directrices [GDC]) a considéré le traitement chiropratique comme un élément faisant partie des soins « traditionnels » dans les stratégies de recherche, mais sans tenir compte des diverses pratiques chiropratiques. De plus, les connaissances fondées uniquement sur l’expérience clinique étaient considérées comme moins valables et moins sûres que des éléments probants de bon niveau, mais lorsque la preuve était de faible niveau ou inexistante, on a pris en compte l’expérience clinique non publiée, tenue pour équivalente ou meilleure que la preuve publiée. BÉNÉFICES, DOMMAGESET COÛTS DÉCLARÉS Les bénéfices attendus des recommandations sont une guérison plus rapide de la douleur, du handicap et de l’invalidité (atténuation de la douleur et amélioration de l’ADM). Le GDC a mis en évidence des résultats favorables sur la douleur fondés sur des éléments probants, provenant de 10 traitements à mode unique et plus de 7 traitements à modes multiples. On n’a pas observé de résultats favorables sur la douleur avec l’application d’aimants autour du cou, l’éducation ou la relaxation seules, le relâchement occipital seul, ou bien des exercices combinant tirages et extensions de la tête seuls. La spécificité des traitements étudiés signifiait que peu d’études pouvaient être généralisées à plus qu’une minorité de patients. Les événements indésirables n’ont pas été abordés dans la plupart des études, mais lorsque c’était le cas, soit on n’en n’observait pas, soit ils étaient mineurs. Le préjudice théorique d’une dissection de l’artère vertébrale (DAV) n’a pas été signalé mais une analyse suggérait qu’une DAV pouvait se produire après un million de manipulations cervicales. Les coûts n’ont pas été analysés dans cette ligne directrice, mais il appartient au GDC de comprendre que les recommandations limitant les soins de santé inefficaces et encourageant un retour plus rapide des patients à leur pleine capacité fonctionnelle réduiront les coûts liés aux patients mais accroîtront également la sécurité et la satisfaction des patients. Pour faire simple, cette version de la ligne directrice comprend essentiellement des données synthétisées d’études (synthèses d’éléments probants), attendu que les versions techniques et interactives de cette ligne directrice (http://ccachiro.org/cpg) comportent également des données pertinentes provenant d’études individuelles (extractions d’arguments probants). RECOMMANDATIONS Le GDC a élaboré des recommandations en matière de traitement, de gestion des risques et de recherche en utilisant les arguments probants disponibles. Les recommandations sur le traitement abordant 13 modes de traitement sont axées sur un algorithme de décision comprenant le diagnostic (ou l’évaluation menant au diagnostic), le traitement et la réévaluation. Plusieurs variantes particulières de modes de traitement n’ont pas été recommandées. En ce qui concerne les événements indésirables qui ne sont pas associés à une maladie, mais qui surviennent en milieu clinique, rien n’indiquait de recommander une remise en cause des options de traitement ou d’en référer aux services de santé compétents. Pour les événements indésirables associés à un mode de traitement, mais ne constituant pas un facteur de risque connu ou observable, rien n’indiquait de recommander une vigilance accrûe au moment de prévoir ou d’administrer un traitement pertinent. Concernant les événements indésirables associés à un mode de traitement et prédits par un facteur de risque observable, rien n’indiquait de recommander une contre-indication formelle et d’exiger une modification du mode de traitement ou bien de mettre en garde en vue de minimiser les dommages et de maximiser les bénéfices. En ce qui concerne la gestion du risque théorique de dissection, rien n’indiquait de recommander une approche systématique de la gestion des risques. En matière de gestion du risque théorique d’accident vasculaire cérébral, rien n’indiquait de recommander un roulement minimal des modes de traitement de la colonne cervicale supérieure et de recommander la prudence dans le traitement d’un patient souffrant d’hyperhomocystéinémie, bien que la preuve soit particulièrement ambiguë dans ces deux domaines. Les recommandations en matière de recherche ont abordé le faible niveau présenté par de nombreuses études; le GDC a conclu que la base scientifique des traitements chiropratiques destinés à traiter les cervicalgies n’était pas de qualité ou de portée suffisante pour « couvrir » complètement la pratique chiropratique actuelle, même si cela ne veut pas dire que d’autres disciplines sont plus susceptibles de s’appuyer sur des arguments probants. VALIDATION Cette ligne directrice a été rédigée par les dix membres du GDC (Elizabeth Anderson-Peacock, Jean-Sébastien Blouin, Roland Bryans, Normand Danis, Andrea Furlan, Henri Marcoux, Brock Potter, Rick Ruegg, Janice Gross Stein, Eleanor White) en s’appuyant sur le travail de trois équipes en charge de la recherche bibliograhique et d’une équipe en charge de l’extraction des éléments probants, et à la lumière des remarques d’un commentateur (Donald R Murphy), d’un comité de révision composé de cinq personnes (Robert R Burton, Andrea Furlan, Richard Roy, Steven Silk, Roy Till), d’une commission d’étude composée de six personnes (Grayden Bridge, H James Duncan, Wanda Lee MacPhee, Bruce Squires, Greg Stewart, Dean Wright) et de deux critiques d’avant-projets complets, menées dans toute la profession, à l’échelon national. Deux rédacteurs professionnels possédant une grande expérience des lignes directrices ont été engagés par contrat (Thor Eglington, Bruce P Squires). Des collaborateurs essentiels à la directive ont participé à ce travail, notamment des personnes ayant des spécialités ou une connaissance experte dans les domaines de la chiropratique, de la médecine, des procédés de recherche, des procédés d’analyse documentaire, des processus d’orientation de pratique clinique, des associations de protection, des affaires réglementaires et de l’intérêt public. Cette ligne directrice a officiellement fait l’objet d’une révision par des pairs. 1. Introduction (details http://ccachiro.org/cpg) Neck pain is an important cause of reduced quality of life (QoL) and carries a high economic cost.1,2 In a recent Toronto (Canada) clinic survey,3 neck problems were the foremost reason for seeking chiropractic care. Overall, 25% of primary complaints among chiropractic patients likely involve neck pain.3 This clinical practice guideline (CPG) reflects evidence extracted from the published scientific literature about effective chiropractic cervical treatments for adult patients suffering from neck pain not due to whiplash. The CPG presents statements and recommendations synthesized from this evidence, and rates the “confidence” (strength) of each. It also identifies treatments for which evidence of ineffectiveness exists. This CPG does not provide a comprehensive overview of chiropractic treatment; any deficiency or omission directly reflects a deficiency or omission in the clinical literature.
1.1. Operational definitions Chiropractic treatment was unanimously defined by the Guidelines Development Committee (GDC) as including the most common treatments employed by chiropractors but excluding: acupuncture; surgical procedures; invasive analgesic procedures, including nerve blocks, neuroablative procedures, epidural blocks, and facet and intramuscular injections; injections of botulinum toxin; systematic psychological interventions such as cognitive or behavioral therapies for anxiety or depression; and, prescription of over-the-counter or prescription drugs. Neck was unanimously defined by the GDC as the vertebral motion segments (vertebral muscles, ligaments, nerves, discs) that constitute the neck; that is, the portion of the spine located between the skull and the rib cage, the vertebrae of which are characterized by their relatively small size and the absence of ribs.4 We deem chiropractic care to be of value across several age groups, but this CPG was limited to adults (18 or more years of age). Therefore, we searched and analyzed the literature related to adults only. This guideline only addresses pain originating in the neck. Also, it does not address pain referred from the neck to the cranium or to the upper extremities (below the acromioclavicular joint). Pain was defined as whichever assessment method a study used to evaluate it, be it of mechanical, non-mechanical, idiopathic, or pathologic origin. However, this CPG does not address pain resulting from whiplash injury, which we consider to be different from other pain (more details http://ccachiro.org/cpg); whiplash pain results from a unique, complex, coupled movement of the cervical spine involving simultaneous flexion, extension and axial compression, subjecting the cervical spine to an unnatural double curvature at the time of injury.5 Also, this CPG does not address headache, which was considered outside of the practical scope of our work. 2. Methods (more details http://ccachiro.org/cpg) The operational methods to develop and deploy this CPG were articulated in a development, dissemination, implementation, evaluation, and revision plan (DevDIER).6 The detailed development methods can be found in the technical version of this CPG (http://ccachiro.org/cpg); a summary follows. The methods involved sequential contributions from literature search teams, an evidence-extraction team and a review panel – under the auspices of The Canadian Chiropractic Association and the Canadian Federation of Chiropractic Regulatory Boards, Clinical Practice Guidelines Development Initiative, GDC. Unanimity (complete agreement) within the relevant contributor groups was achieved at every stage of development. Two development drafts of the guideline were released for profession-wide critiques, the results of which were then incorporated. 2.1. Literature searches Four electronic literature searches were undertaken: treatment (English and German, up to August, 2003); risk management (managing the risk of non-dissection adverse events, English and French, up to October, 2004); dissection risk management (the theoretic association between manipulation and dissection or stroke, English, up to September, 2003); and treatment update (English and French, for the period between September, 2003 and November, 2004 inclusive). The results of each search were downloaded into an electronic data set, and duplicates were manually removed. Some additional studies were added manually to each data set. The studies were retrieved and passed to the evidence-extraction team (TE, BPS). 2.2. Evidence extractions (data from individual studies) Evidence extractors manually applied the operational definitions (Section 1.1) to reject studies or data that clearly did not respect these. Studies that contained both acceptable and unacceptable information were not rejected, but clearly unacceptable data within these studies were rejected. The 2 extractors recorded statistically significant results from the literature (p-value less or equal to 0.05), as well as non-significant findings where deemed appropriate. All relevant numeric data were extracted from studies into an electronic database; the extractors did not rely on study abstracts. Table 1 adapted from the Oxford Centre for Evidence-based Medicine (OCEBM) levels of evidence7 was used to categorize results into rated evidence extractions. For treatment evidence, the extractors together used the OCEBM levels of evidence to rate the quality of each extraction, and then reached unanimity about all aspects of each extraction. For the evidence related to dissection, the 2 extractors reached unanimity about all aspects of each extraction. For evidence related to other risk-management concerns, because of the poor caliber of evidence, the 2 extractors were able to independently complete extraction work that was later amalgamated by one (TE).
For treatment evidence, the extractors accepted all Level 1 to 4 evidence, but Level 5 evidence only if it arose from a Level 1 to 4 study; e.g., if it was the study authors’ extrapolation from the study data (Table 1). For risk-management evidence, all Levels were accepted. Where applicable, the rating of extractions are cited in parentheses (e.g., {L-4}). Where relevant, the GDC’s interpretations of study results are included as Level 5 evidence extractions and cited as such (i.e., {L-5} or {L-5}GDC). Evidence extractions were ultimately verified by the GDC in the course of recommendation-development workgroups (Section 2.4). 2.3. Evidence Syntheses
For simplicity, this version of the CPG focuses on evidence syntheses, whereas the technical and the interactive versions of this CPG (http://ccachiro.org/cpg) also include all evidence extractions from individual studies. The extractions in those versions report all relevant study outcomes, but the syntheses included here focus on pain and ROM, because these two outcomes were the most consistently reported. One extractor (TE) developed the treatment syntheses, and then the 2 extractors together examined them all to reach unanimity. One extractor (TE) completed all the risk-management syntheses. Evidence syntheses were ultimately verified by the GDC in the course of recommendation-development workgroups (Section 2.4). 2.4. Formulating recommendations The 10 members of the GDC qualitatively interpreted the clinical relevance of the evidence extractions and syntheses. Therefore, all recommendations should be considered to be a subjective extrapolation, “equivalent” to an OCEBM Level 5 rating. Extractions and syntheses were used to formulate treatment, risk-management or research recommendations during collaborative work sessions. Risk-management and research recommendations incorporated a substantial amount of the GDC’s (unpublished) expertise, whereas treatment recommendations purposefully incorporated little. The work-groups considered outcomes, the caliber of evidence, and an assessment of clinical relevance to reach unanimity about each recommendation. Clinical relevance included the deemed importance of the practice in chiropractic, the deemed over- or under-use of the practice in chiropractic, and the deemed importance of reported outcomes (calculated effect sizes were unavailable). A 5-member panel reviewed a draft set of the treatment evidence syntheses and the treatment recommendations, and advised the GDC about these. The GDC determined with unanimity how to incorporate this advice into the CPG. 3. Results: general (details http://ccachiro.org/cpg) Where applicable, the rating of an evidence extraction or synthesis is cited in parentheses (e.g., {L-4}). Where relevant, the GDC’s interpretations of study results are included as Level 5 (i.e., subjective extrapolation) and cited as such (i.e., {L-5} or {L-5}GDC).
3.1. Treatment evidence
No treatment data were drawn from the reviews or the CPGs we found because of a confounding mix of outcome or treatment data from back and neck pain patients, or confounding mix of outcome or treatment data from whiplash and non-whiplash patients. Also, single study results were excluded if they appeared to confound these data. Ultimately, treatment evidence was extracted from 90 studies for the development of treatment syntheses and recommendations (Section 4). Studies were generally of medium quality, and many abstracts suggested the studies were of much higher quality than their methods illustrated. In general, considerable effort was required to extract pertinent results from needlessly ambiguous articles. We agreed with others8 that a treatment effect size less than 0.5 was clinically unimportant {L-4}, and that an effect size from 0.5 to 0.79 was moderately important, and 0.8 or more, important {L-5}.9 The effect size of treatments in the literature was infrequently reported, and where it was, it was usually unimportant or moderately important. Section 7.1 addresses the practical issue10 of what percentage of improvement in pain on numeric scales is clinically important. Also, where clearly defined, individual modalities generally differed between studies (e.g., Tables 1 and 2 in the technical version [http://ccachiro.org/cpg]) and dramatically reduced our ability to synthesize results across studies into definitive, clinically applicable recommendations.
Thirteen studies9–21 reported whether adverse events occurred (Table 2) and 7 studies10,17,18,21–24 included placebo comparison groups. Twelve studies22,25–35 included a no-treatment comparison group; only for studies in which across-group comparisons were clear22,25–30 were we able to conclude that treatments were or were not better than no treatment. 3.2. Risk-management evidence We were unable to extract useful information from many articles because the results were inconclusive, the conclusions were not self-evident, or the topic was considered outside of the scope of common chiropractic (e.g., interpreting blood assay or bone densitometry results). We determined that 79 studies or reports were relevant to the hypothetical association between manipulation and dissection. Rated evidence extracted from these supported the development of syntheses and recommendations (Appendix 1). The well-established predisposing risks for cardiovascular disease, atherosclerosis or stroke were summarized by extracting information from Wolf,36 and those about the well-established physiologic parameters governing exercise treatments were summarized by extracting information from Kisner and Colby.37 Of 230 articles about adverse events that did not deal with these 2 topics or dissection, evidence was extracted from 56 and rated, to support the development of syntheses and recommendations (Section 5, Appendix 2). 4. Results: treatment (details http://ccachiro.org/cpg)
This CPG focuses on treatment, and does not explore fully the available systems of assessment, such as those listed in the 2003 summary of pre-manipulative assessment procedures by Hing et al.38 The recommendations in this CPG were made with the caveat that it is each chiropractor’s responsibility to implement the appropriate risk-management procedures when implementing the treatment recommendations. Where relevant, the statements below indicate the modality used and the approximate time effects were measured: immediate (less than a 1 day); short term (1 day to 3 weeks); medium term (3 weeks to 6 months); or long term (more than 6 months). Table 3 in the technical version (http://ccachiro.org/cpg) provides details of studies’ specific manipulation techniques, and Table 4 in the technical version (http://ccachiro.org/cpg), exercise.
Immediate benefit from manipulation Short- and medium-term benefit from manipulation Multiple manipulations improve pain in the short {L-4}43–46 and medium {L-4}43,46–48 term, and some ROM in the short {L-4}43,44,46,48 and medium {L-4}12,43,45–48 term. Manipulations in and opposite the direction of restriction may achieve greater ROM benefit than manipulation only in the direction of restriction {L-2b}.44 Also, thoracic manipulations do not enhance the benefits from cervical manipulations in the short term {L-2b}.48
Short- and medium-term benefit from manipulation with stretching Multiple manipulations, each preceded or followed by stretching of neck muscles, improve pain in the short and medium term {L-4};20 stretching either causes the relief or merely adds benefit to manipulation {L-5}.GDC Multiple manipulations with or without {L-2b} stretching improve ROM in the medium term {L-4}.20 Additionally, multiple manipulations may be better than unsupervised stretching {L-4}.49 Medium- and long-term benefit from manipulation with 3-point traction Immediate benefit from mobilization A single treatment of short mobilization sessions immediately improves pain {L-4},22 and is better than no treatment for an immediate effect {L-2b} (see Section 4.2). Immediate benefit from ischemic pressure Ischemic pressure applied to myofascial trigger points (TrgP) for 90 s immediately improves pain and some ROM {L-4}50 (see Section 4.2). Medium- and long-term benefit from exercise Ongoing exercise improves: pain in the medium and long term {L-4};10 pain in the medium term for patients with unidentified conditions {L-4},32,51–53 with strength exercise being the most consistently beneficial {L-1b};51 and pain and some ROM in the medium term for patients with cervical strain, herniated disc, degenerated discs {L-4},54 osteoarthritis, or “outset” resulting from minor injuries {L-4}.31 The evidence27,31,32 is ambiguous about the advantage of exercise over no treatment, but suggests exercise is better than a placebo of clinical contact {L-1b}.10 It is possible that subjectively perceived benefits such as pain reduction continue well beyond the treatment period, whereas objectively measured benefits do not {L-5}.GDC Medium- and long-term benefit from intensive or light exercise Ongoing intensive or light exercise equally {L-2b} improve {L-4} pain in the long term, and intensive exercise is better than light exercise for objective outcomes in the medium term {L-2b}.55 Medium- and long-term benefit from exercise with education Ongoing exercise with education improves pain in the long term {L-4}, but may be less beneficial than more passive treatment that includes medications for patients with cervical spondylopathy, soft tissue rheumatism, humeral tendinitis, tension neck, cervical syndrome, or rhizopathy {L-5}.56 Also, for patients without defined conditions, exercise-education combinations improve worst pain in the medium term {L-4} and have significantly greater effect than education alone {L-2b};57 this suggests the critical ingredient in exercise-education combinations is the exercise {L-5}.GDC Medium- and long-term benefit from exercise with education and home exercise Medium- and long-term benefit from exercise with multimodal treatments Ongoing exercise with extensive multi-modal combinations improves pain and some ROM for patients with unspecified conditions in the medium35, 58, 59 and long58 term {L-4}. It also improves pain and some ROM in the medium term for patients with osteoarthritis, cervical spondylopathy, strain, or cervical disc disease {L-4}.60 In an exercise combination, exercise is likely most effective at improving objective outcomes, whereas the other modalities address subjective outcomes {L-5}.GDC There is conflicting evidence whether exercise is better than general medical care for pain in the medium {L-5}GDC and long {L-2b}33 term. Finally, the addition of more exercise to an exercise combination improves satisfaction and maintained benefit {L-5},GDC but is not as good as extending the scope of the multi-modal treatment {L-4}.59 The evidence35 is ambiguous about exercise’s advantage over no treatment {L-5}.GDC Summary exercise benefit statement Multiple multi-modal treatments are the most effective and exercise, especially intensive exercise, is a critical element {L-5}.GDC Overall, in addition to pain and ROM outcomes, ongoing strength exercise increases strength, ongoing endurance exercise increases endurance, but the outcome of coordination exercise is ambiguous {L-5}.GDC In addition, where it was reported,28,31,32,58 exercise was not consistently better than placebo or no-treatment groups {L-5};GDC the propensity for neck pain to resolve on its own may be a confounding factor (see Section 4.1). Short-, medium- and long-term benefit from home exercise with or without education or ultrasound Home exercise may improve pain and some ROM in the medium and long term {L-4},29,61 but extensive tailoring of the home exercise to each patient is required {L-5}.GDC Some evidence {L-2b}29 suggests that home exercise may be no better than no treatment for pain or ROM {L-5}.GDC Home exercise with education or monitoring improves pain and some ROM in the medium term {L-4}.16 Home exercise with ultrasound improves pain in the short and medium term {L-4}; ultrasound enhances the effect of home exercise alone {L-2b},62 but not home exercise with massage {L-5}.GDC However, home exercise with ultrasound is no better than no treatment for pain {L-2b}.28
Short- and medium-term benefit from ultrasound Multiple ultrasound treatments improve pain and some ROM in the short and medium term {L-4}.45 Short- and medium-term benefit from low-power laser treatments Medium-term benefit from pillows Use of a cervical pillow during sleep improves pain in the medium term {L-4}.64
Short- and medium-term benefit from pulsed electromagnetic field therapy Multiple pulsed electromagnetic field treatments improve pain and some ROM in the short and medium term {L-4}.17,18,24 The pulsed electromagnetic field quality of the various vectors used (collar, electrode-points) shows better results than placebo {L-1b}24 {L-2b},17,18 which suggests that it is causal {L-5}.GDC
Immediate, medium- and long-term benefit from multimodal treatments Multi-modal treatments improve pain and some ROM in the medium and long term {L-4};13,15,19,34,65 there is no discernable difference between combinations as long as they include home exercise, education, traction, 1 other secondary modality, and either manipulation, mobilization or clinic-based exercise {L-2b}.13 A single multi-modal treatment improves pain or pain and some ROM immediately {L-4}.50 For example, one treatment of a 20-min hot-pack, active ROM, interferential current, and myofascial release (role of ischemic pressure undefined) is the first choice of 6 options of multi-modal treatments using secondary modalities to improve immediately: pain intensity, pain pressure tolerance, and pressure point thresholds (PPT) {L-5}GDC (see Section 4.2). The 6 treatments, from most effective to least, are:
No additional benefit from magnets in necklaces It is nearly certain that magnetic necklaces are no better than non-magnetic necklaces to improve pain in the short term {L-1b}, although improvement in pain follows the wearing of both {L-4}.66
No benefit from education or relaxation alone Education alone does not improve pain51,57 or ROM57 in the medium term {L-4}. Relaxation treatments are equal {L-2b} to advice to be active, in not improving pain or ROM in the medium or long term {L-4}.27
No immediate benefit from head retraction-extension exercise combinations alone Head retraction-extension exercise combinations do not immediately improve pain {L-4}.30
No immediate benefit from occipital release treatments alone Occipital-release treatments do not immediately improve pain {L-4}.30
4.1. Natural history of neck pain Men and women may experience neck pain differently. More men have acute pain, whereas more women have chronic pain.67 Men also gain more pain relief from chiropractic treatment.68 We agree with at least five reports69–73 that pain is consistently associated with functional loss (e.g., altered patterns of neck muscle activation, reduction in strength and endurance) {L-5}, which may be without outwardly obvious structural change such as degenerative disease {L-2c}.74 Acute neck pain in adults is generally regarded to be self-resolving. One report75 on patients with acute and chronic back disorder suggested that 90% of neck or back pain cases had self-resolved at 6 weeks {L-5}, corroborating another report.34 Also, a review76 on patients with neck pain suggested that more than 50% of patients experience a decrease in pain 2 to 4 weeks after onset and 80% will be asymptomatic in 2 to 3 months {L-5}. Another study suggested that patients (defined as chronic) who spent 16 weeks on a waiting list for physiotherapy experienced improved pain, cortical control, and 6 of 22 elements on an examination and physiologic test index {L-4}.33 We caution that there can be a structural or functional detriment associated with some patients’ pain, and we agree with at least one author69 that the resolution of the pain may not signal a complete resolution of the detriment {L-5}. Specifically for these patients, even if treatment does not result in a faster or greater improvement in pain, good treatment will also address non-pain problems, which left untreated, may have permanent sequelae {L-5}.GDC This justifies treatments that are expected to show less or slower improvement than the expected natural history of the treated pain in these patients {L-5}.GDC Authors of a Saskatchewan study77 suggested that complete resolution of pain or disability is difficult to achieve (treatment status undefined) {L-2c}, and other authors reported that half of patients treated with primary care did not experience complete resolution after 1 year78 or 5 years79 (specific treatment type or consistency over the period undefined) {L-2c}. For patients whose pain is not self-resolving, we agree with at least 3 reports68,80,81 that there may be a treatment opportunity to halt the evolution of acute pain to a chronic condition {L-5}, perhaps specifically for patients predisposed to chronic pain for non-pathologic reasons (low self-rated health and high levels of psychologic stress) {L-5}.80 Therefore, we concluded that good practice does not universally mean waiting to find out whose pain resolves, and whose does not, before proceeding with treatment {L-5}. We therefore recommend:
In the recommendation above; Support Care means the necessary care for patients who have reached maximum therapeutic benefit, and for whom periodic trials of therapeutic withdrawal have led to deterioration and failure to sustain previous therapeutic gains. This form of care is initiated when the clinical problem recurs.82 Maintenance Care means elective care given at regular intervals designed to maintain maximum health and promote optimal function. It may incorporate screening procedures designed to identify a risk of developing problems pertaining to the patient’s health status and giving advice about this.82 Wellness Care means elective care given at regular intervals designed to maintain maximum health and promote optimal function. 4.2. The role of focusing on immediate clinical outcomes Seven treatment studies11,22,39–42,50 focused on improved pain or ROM immediately after a single treatment. These treatments do not reflect a typical treatment plan. However, it is our understanding that an immediate post-treatment reduction in pain or increase in ROM suggests that the particular patient’s pain or ROM responds to the treatment and that subsequent treatments will reap further short-, medium- or long-term benefits {L-5}. In addition, we consider that a legitimate role for a single treatment that provides an immediate relief of pain, if administered without temporarily increasing pain, is to permit another intervention that would otherwise be too painful for the patient to bear {L-5}.
4.3. Multi-sectoral care A key to successful chiropractic treatment appears to be integrated care that accommodates clinical sectors that may fall outside of some chiropractors’ practice. For example, unimodal and multimodal treatments that incorporate behavior modification16,29,83 or pharmacologic interventions12,19,56,62,75,83–92 have shown benefit. It is our understanding that integrated care means the integration of all modalities of treatment into an optimal care plan for a particular patient, including those chiropractic modalities supported by the evidence that is the foundation of this CPG {L-5}.
5. Results: managing the risk of adverse events (details http://ccachiro.org/cpg)
Chiropractic regards the objective and subjective balance of benefits and the risk of adverse events to be especially important. The direct benefits of the treatment recommendations are expected to include those reported in the studies cited in Section 4, and reduced sick days and increased strength, endurance, flexibility, QoL, and ease of activities of daily living (ADL)–see technical version at http://ccachiro.org/cpg for details. Counter-balancing these benefits is the risk of adverse events. For clarity, adverse events can be considered to be of 3 types:
These delineations are not static; for example, an adverse event that is associated with a treatment modality, but not predicted by a risk factor, may progress to being so (predicted by a factor) once this has been identified. We deem that it is a chiropractor’s responsibility to understand and address all three types of adverse events (non-Tx-AE, unforeseen-Tx-AE, foreseen-Tx-AE) {L-5}. Determination of the appropriate clinical response to an adverse event associated with a treatment, or to the relevant risk factor, is complicated by the manual nature of many chiropractic therapies. The risk of harm following treatment depends directly on the skill of the chiropractor {L-5}.GDC Jagbandhansingh93 echoed this conclusion in a 1997 review of USA malpractice claims: “Chiropractic care in itself may not pose a clinical risk. However, treatment in association with lack of good professional judgement [or] failure to properly assess a patient’s condition may” (p. 64).
5.1. Managing the risk of adverse events not associated with a treatment modality, but that occur in the clinical setting (non-Tx-AE) Chiropractors receive patients from all sectors of the population and may encounter any of the health problems that afflict everyone. Indeed, chiropractic patients are likely disproportionately ill compared with the general population. Côté et al.94 reported that Saskatchewan patients seeking chiropractic care frequently presented with a wide array of serious comorbidities {L-2c}, such as heart disease. When undiagnosed, these health problems may precipitate a non-Tx-AE before, during or after a treatment. Reports have described patients seeking care for symptoms treatable with chiropractic, but who have undiagnosed ailments outside of the scope of practice. For example: the symptoms of various pathologies, such as systemic lupus erythematosus, Bornholm disease,95 neoplasms95,96 (osteoblastoma),97 cervical fracture,98 or internal carotid artery dissection99 (ICAD) can mimic mechanical neck pain; the symptoms of myocardial infarct (MI) can masquerade as neck pain100 (and vice versa);101 seizures or transient ischemic attacks (TIA) can mimic migraines;102 neck and jaw pain can result from Marfan syndrome without spinal involvement;103 undetected septic arthritis can be harbored in patients complaining of joint pain while taking glucocorticosteroid therapy;104 and pain coincident with trauma can be paralleled by undetected cervical fractures,105 or (later) acute respiratory distress syndrome (ARDS) leading to death.106 Comorbidities can also be missed when overt signs are present, as when surface lesions in acute scalp lymphangitis indicated an untreated infection masquerading as cervical pain in at least one case.107 Attempts to systematically address the identification of serious comorbidities in advance of care may include using a 15-item self-report tool developed by Côté et al.94 It is our understanding that a set of 15 presenting symptoms (adapted from McMillin)108 should raise suspicion that the presenting cervical pain is not of mechanical origin {L-5}:
When a relevant comorbidity or a non-Tx-AE is noted, chiropractors have a responsibility to act in the best interest of their patients by immediate consideration of the situation, and referral to the appropriate healthcare resource as necessary.
5.2. Managing the risk of adverse events associated with a treatment modality, but not a known or observable risk factor (unforeseen-Tx-AE) Managing the risk of unforeseen-Tx-AEs involves reacting appropriately if an event is noted. By definition, an unforeseen-Tx-AE follows the administration of a particular treatment, but there are no known factors differentiating patients at greater risk from others. Thirteen9–21 of the treatment studies reported about unforeseen-Tx-AEs (Table 2). Reports ranged from none10–13,16,18,20,21 to those considered minor and self-resolving among a small fraction of study subjects,14,15,16 or minor.9,19 The worsening of symptoms with treatment was also reported,9,10,14,64 but it was not possible to determine if this was as a result of treatment failure or an unforeseen-Tx-AE. Richardson et al.109 reported that about half of 98 patients had “some discomfort” following a 4-week trial of TENS {L-4}. About one-fifth had “unpleasant sensations” at or away from the TENS site, and a smaller number had headaches, muscle aches, nausea, bad temper, or dizziness. A systematic review110 {L-1a} concluded that in a minority of patients, high-frequency (HF) TENS could cause skin rash whereas low-frequency (LF) TENS could cause a burning sensation over the area of electrodes, and HF-TENS or LF “train TENS” could cause skin irritation {L-5}. Regarding manipulation; benign and transient unforeseen-Tx-AEs, or none, have been reported in a recent systematic review,111 a comprehensive study112 of more than 250 subjects, a prospective survey of 1, 058 patients,113 a prospective survey of 465 patients,114 and 2 extensive literature reviews.115,116 In their 2003 study, Hurwitz et al.112 reported that “No serious complications from spinal manipulation or manual treatment have been reported... [in] any of the published clinical trials involving [spinal] manipulation or mobilization” (p. 21). Hurwitz et al.112 suggested that manipulation conferred a greater risk than mobilization for benign, transient unforeseen-Tx-AEs that usually occur within 24 hours of treatment {L-5}. Indeed, about 5 of every 100 patients treated with manipulation will feel “very noticeable” discomforts, whereas about 20 will feel moderate discomfort, and about 15 will feel slight discomfort {L-4}.117 This total of affected patients (40 of 100) approximates the 34% to 55% estimate by Cagnie et al.114 In more than 80% of these cases, discomforts disappeared within 24 hrs, and in more than 85%, discomforts occurred on the day of the manipulation {L-4}.117 Rare, unforeseen-Tx-AEs include spinal cord compression, facet edema, disk herniation,116 long thoracic nerve palsy,118 ruptured cervical discs,119 and diaphragm paralysis related to phrenic nerve trauma.120 In addition, women and younger patients (27 to 46 years) have reported more complaints {L-2c}.113
Without considering the issue of dissection, patient differences in susceptibility to adverse events related to manipulation are apparent (being female, being older, smoking, regular medication use, history of migraine) {L-4}.114 However, we agree with the conclusion suggested by the results of Cagnie et al.114 that these risk factors have not been consistently predictive, and we question their clinical utility {L-5}. 5.3. Managing the risk of adverse events associated with a treatment modality and predicted by an observable risk factor (foreseen-Tx-AE) Managing the risk of foreseen-Tx-AEs involves respecting risk factors and reacting appropriately if an adverse event is noted. We extracted a list of factors from the risk management literature we found (more than 6,774 citations, more than 309 relevant articles), which likely constituted all reported foreseen-Tx-AEs. This list reflected our understanding of each relevant study’s determination of whether, strictly within the context of the study, the factor was a contraindication to the studied treatment modality, or merely indicated a requirement for caution {L-5}.GDC We concluded that most of the contraindications we had listed were likely not contraindications outside of the specific study context or with patients other than the studied cases {L-5}.GDC Many of the comorbidities Côté et al.94 reported in their survey of 1,131 Saskatchewan patients seeking chiropractic care {L-2c} were considered contraindications in this list. These included arthritis (26.8% of patients seeking a chiropractor only, 50% of patients seeking a chiropractor and medical physician), cardiovascular disease (12.2%, 25%) and significant depressive symptoms (22.5%, 38.5%). Most of the ailments that mimic mechanical pain for which patients may seek chiropractic treatment (Section 5.1) were also considered contraindications in this list: systemic lupus arythmetous, Bornholm disease95 or neoplasms95,96 (osteoblastoma),97 seizures, TIAs,102 Marfan syndrome,103 undetected septic arthritis,104 and cervical fractures.105 With most patients presenting with one or more of the factors we listed as a contraindication or caution, we deem that best practice rests on differentiating these factors into absolute contraindications (Section 5.3.1), factors requiring modification of a desired treatment modality (Section 5.3.2), or factors suggesting caution (Section 5.3.3).
5.3.1. Risk factors that are absolute contraindications Where a risk factor signals a contraindication to an effective treatment modality, we deem that best practice comprises discontinuing care and immediate referral to emergency health services, or merely discontinuing the modality and an in-depth consideration of alternative modalities or referral. Barring obvious medical emergencies (e.g., onset of myocardial infarct), we identified only 3 risk factors that are absolute contraindications that require immediate discontinuance of care and referral to emergency health services in the course of care: 1) at least 1 of 4 signs or symptoms of neurovascular impairment (unilateral facial paresthesia, objective cerebellar signs, lateral medullary signs, visual field defects), or other signs or symptoms of neurovascular impairment with unknown cause; 2) neck or occipital pain with a sharp quality and severe intensity that is sudden and unlike any previously experienced pain (even when it is suspected the pain is of a musculoskeletal or neuralgic origin); and 3) severe and persistent headache that is sudden and unlike any previously experienced headache (even when it is suspected the pain is of a musculoskeletal or neuralgic origin) {L-5}.GDC These are absolute contraindications to all treatment modalities {L-5}.GDC All other risk factors we identified as absolute contraindications require merely discontinuing a specific treatment modality, and considering alternative modalities or referral. Tables 3a to 3h list absolute contraindications based on evidence extracted from the articles we found. Tables 3a to 3h extensively incorporate the GDC’s (unpublished) practice expertise, and the Tables are thus of a Level 5 caliber. In Tables 3a to 3h, conditions or syndromes are not expected to be diagnosed within the scope of chiropractic practice, unless otherwise noted. All other definitions cited in this CPG apply. 5.3.1.1. Risk factors that are absolute contraindications to an HVLA manipulation can also be absolute contraindications to a manipulation that is not HVLA or mobilization Tables 3b and 3c list risk factors that are absolute contraindications to manipulation when defined as a high velocity, low amplitude (HVLA) thrust. The principle behind these absolute contraindications is that aspects of administering the manipulation (e.g., force, direction, amplitude, velocity, patient position, frequency, duration, location of treatment) may exacerbate the risk factor or other adverse events made possible by the factor (e.g., thrombi “resting” in a cervical aneurysm may be dislodged by an HVLA thrust and ascend to the brain, osteoporosis in the cervical vertebrae may weaken bone to the point where an HVLA thrust will cause fracture).
Manipulation that is not HVLA or mobilization are generally considered by the profession to be potential options where an HVLA thrust is contraindicated {L-5}.GDC However, we deem that where it is the mere movement of neck tissues that causes a risk factor to be an absolute contraindication to an HVLA thrust, manipulation that is not HVLA or mobilization are equally contraindicated by this factor {L-5}. We consider that it is a practitioner’s responsibility to acquire the practice experience and expertise to identify which factors are risks because of the mere movement of neck tissues {L-5}. 5.3.2. Risk factors that require treatment modality modifications Compiling a list of all risk factors requiring modification of a desired treatment modality was beyond the scope of this CPG. Essentially every characteristic of a patient constitutes a factor; chiropractic uses treatment modalities specifically tailored in innumerable ways to each patient’s needs. This flexibility of treatment greatly expands treatment possibilities, allowing, for example, forceful or non-forceful maneuvers, or tangential or direct segment application. Where a risk factor does not signal a contraindication to a treatment modality, but does signal a specific tailoring of the desired modality, we deem that best practice comprises a systematic approach to modifying the administration of the modality; the risk factor signals a “modality modification.” Table 4 lists the aspects of core treatment modalities that we concluded should be considered by practitioners when faced with a modality-modifying risk factor, in the context of their practice experience and expertise {L-5}. Our literature search did not reveal any evidence supporting or refuting this list, and thus Table 4 incorporates solely the GDC’s (unpublished) practice expertise. 5.3.3. Risk factors that require treatment caution Compiling a list of all risk factors requiring caution in treatment was beyond the scope of this CPG. Essentially, caution should always be exercised as part of good practice {L-5}.GDC Thus, this CPG specifically identifies factors where we concluded there was a lack of clarity between these factors and those that indicate modality modifications or absolute contraindications {L-5}. Table 5 summarizes these “caution-indicating” risk factors.
We define caution as proceeding with a particular treatment modality only after an assessment that is as thorough as possible indicates the risk with administering this modality is not exacerbated. In the context of good practice always involving caution, the clinical importance of the above is that in some cases this assessment will lead to the conclusion that a risk factor initially indicating caution is, in truth, an indicator for modality modification (Section 5.3.2) or a contraindication (Section 5.3.1). For example, with thorough assessment, multiple cautionindicating risk factors presenting in a patient may (together) indicate modification of, or a contraindication to the desired treatment modality. 6. Results: research recommendations (details http://ccachiro.org/cpg) 6.1. Compared groups The GDC embarked on creating this CPG believing there was a large base of scientific studies available. The GDC has concluded from its work translating the results of these studies into a set of concise recommendations, and agrees with others’ conclusions,120,121 that the scientific base for chiropractic cervical treatment of neck pain is not of sufficient quality or scope to “cover” current chiropractic practice comprehensively, although this should not suggest other disciplines are more evidence based. In addition, the specificity of the studied treatments meant few studies could be directly generalized to more than a minority of patients. We concluded that the result was an imbalance in the quantity and quality of our treatment evidence; that is, some infrequently used treatments have greater prominence than their use in practice warrants (e.g., 3-point traction, pulsed electromagnetic fields), and some frequently used modalities are not dealt with clearly and directly. Ultimately, this likely means that the clinical usefulness of the evidence and recommendations may be lower than we would like.
As mentioned in Section 3, individual modalities of treatment generally differed between studies (see Tables 1 and 2). In addition, treatments were often vaguely defined (e.g., “manual therapy”). These factors dramatically reduced our ability to synthesize results across studies, and undermined the usefulness of these studies for practitioners.
6.2. No-treatment comparison groups Only 12 of the studies22,25–35 that supported the treatment recommendations (Section 4) included a no-treatment comparison group. The evidence that showed chiropractic treatment to be clearly better than no treatment was for very specific examples of manipulation with traction or mobilization, where the primary clinical goal was to reduce pain. In light of the potential for self-resolution of pain complaints (Section 4.1), this weakness in a study is fatal to the utility of the study’s results in treating pain.
6.3. Placebo comparison groups In research, a placebo is generally considered an intervention that is used in across-group comparisons, to separate the direct benefits of the studied treatment from the effects of personal contact, the clinical milieu and patients’ belief in these benefits – thereby isolating the critical element of the studied treatment. Only 710,17,18,21–24 of the treatment studies (Section 4) included what their authors considered to be placebo groups. Of these 7 studies, we consider only 3 studies21,22,24 to have used effective placebos. The others used placebos that included more than the factors defined above (palpation,23 physical contact with treatment device,17,18 infrared irradiation10). This merely reflects how difficult it is to design valid placebos in a chiropractic practice laden with physical contact modalities that are, by design, tailored to each patient’s unique needs.122 In addition, research is susceptible to including placebos that are an incremental part of the studied treatment (e.g., palpation compared with palpation plus acupuncture)123 or an independent treatment modality (e.g., ”manual contact” with no segmental movement compared with mobilization).22 Pain is subjective124,125 and strongly influenced by psychologic,80,124,126 cultural,126 physiologic,80,124,127 family, and work127 factors, and the patient’s belief in the effectiveness of a treatment.128 Pain is likely very susceptible to personal contact, the clinical milieu and belief in the benefits of a treatment. Several studies bear this out:
The above, plus our understanding of the holistic approach of chiropractic and the nature of chiropractic modalities, has led us to conclude that what is generally termed placebo effect (effect of contact, milieu, belief) is a valid and integral part of chiropractic treatment of neck pain. This suggests that best practice includes considering contact, milieu and belief as an active treatment modality that can be refined. One repercussion is that future chiropractic research should consistently and specifically examine this.
7. Implementing the recommendations The following information tools are presented to aid in implementing this CPG: a summary Table of the evidence-based cervical pain benefits of chiropractic treatment (Appendix 3); algorithms that illustrate the process of individualizing care (Figure 1
For researchers, a set of CPG development Q&As is included in the first and second Response to profession-wide feedback about the chiropractic clinical practice guideline: evidence-based treatment of adult neck pain not due to whiplash documents available at The CCA web-site. 7.1 Question and Answer List
8. Conclusion Well executed research, and the high caliber evidence this can produce, can objectively quantify outcomes subjectively observed in daily practice. This research can be used to confidently predict the response to a treatment for a clearly delimited problem. Thus, evidence-based practice permits the administration of interventions that are objectively known to produce a favorable clinical response in patients sharing the same problem. This CPG examined the evidence for treatments designed to alleviate neck pain. Pain is fundamentally qualified by its multi-factor origin and the idiosyncratic way it demonstrates itself as a set of symptoms. Thus, we agree with at least one literature review,125 examining the use of research in chiropractic practice, that it is likely impossible for the subjects of any studied group to be experiencing the “same” pain condition – homogeneously susceptible to a tested treatment {L-5}. One repercussion is that a study assessing the impact of a treatment’s effectiveness is unlikely to satisfactorily direct good practice on its own, because it is likely other patients’ pain (and thus treatment needs) will differ from the studied sample. The GDC concluded this is a unique confounder in using evidence-based chiropractic to treat pain. Faced with this, we consider that the most effective method of using the scientific literature in practice includes the application of “individualizing” algorithms. These illustrate the optimal decision path used to tailor objectively-determined treatments, which benefit the average patient, to particular patients – the care that is ultimately offered is thereby unique to each patient.
Appendix 1: Spotlight on dissection (more detail in Appendix 16, technical version at http://ccachiro.org/cpg)
The small sample sizes of the clinical trials supporting this CPG are unlikely to have encountered the rare adverse event of a cervical artery disturbance following manipulation, ranging from arterial insufficiency to vertebral artery dissection.112,144,147,149–155 We consider dissection to be independent of stroke; dissection was differentiated from stroke in several articles, and it was reported that not all dissection led to stroke, and not all stroke was the result of dissection.148,149,156–160 The term “spontaneous” was used often in the literature to describe dissections “without a cause.” However, we agree with several authors161 that it is unlikely that dissection occurs spontaneously, and we do not consider this distinction to be clinically useful. We use the term idiopathic (i.e., unknown cause) to denote dissections reported in the literature as being spontaneous or of unknown cause. The evidence suggests that manipulation is not associated with carotid artery dissection (CAD) {L-4}149,153 {L-5},162,163 and supports our consideration that there is no anatomic basis for an association between manipulation and CAD {L-5}. The remainder of Appendix 1 deals with results reported for dissection in general or vertebral artery dissection (VAD) only, unless discussion of the carotid or basilar arteries is warranted. Some of the literature we retrieved considered “vertebrobasilar” dissection without distinguishing which artery the dissection was in. This imprecision weakens the usefulness of these reports {L-5}.GDC
1.1. Incidence of dissection or VAD or VAD-related stroke associated with manipulation The evidence149,156,161,164–167 suggests that VAD following manipulation occurs very rarely (1 per million manipulations [Appendices 16a, 16b in the technical version of this CPG available at http://ccachiro.org/cpg]), and that most VAD arise from ordinary ADL, but none of the evidence is of sufficient quality to support objective conclusions {L-5}.GDC The core difficulty appears to be that if the rate of manipulation-associated VAD is 1 per million manipulations, 12 million manipulations would have to be studied to reach a scientifically confident conclusion {L-5}167 – a logistically impractical proposition at this time {L-5}.GDC 1.2. Role of manipulation The evidence suggests that more manipulations do not mean more complications {L-4}148 and manipulation does not exacerbate the outcome of dissections {L-4}.149 However, the evidence also suggests there is a statistical association between manipulation and bilateral VAD149,153,156,168 (with VAD symptoms moments to 10 days later), but not unilateral VAD {L-4},149 and between manipulation and VAD within 30 days {L-4}.153 Contrasting one study {L-4}149 but supported by another {L-4},168 we deem that it is unlikely (based on anatomic principles) that manipulation can be responsible for bilateral VAD but not unilateral {L-5}, and thus an association between manipulation and bilateral VAD is likely not clinically important {L-5}.GDC Also, as suggested by Hufnagel’s results {L-4},156 it is unlikely (based on physiologic principles) that a manipulation can be responsible for a VAD more than 3 weeks later {L-5};GDC thus, a 30-day association between manipulation and VAD is likely not clinically important {L-5}.GDC Considering the possibility that manipulation may cause dissection directly, we strongly agree with Sackett’s167 suggestion that none of the available evidence shows causation. However, the evidence does suggest that patients with impaired vertebral artery flow may seek manipulative care for symptoms of these impairments {L-4}148 {L-5}.149,150,154
1.3. Managing the issue of dissection Irrespective of cause, it appears there may be a remote risk of VAD occurring subsequent to manipulation {L-5}.GDC We agree with Magarey et al.146 that this risk is a clinical factor to be managed, much as drug side effects are in pharmacotherapy and anesthetic adverse events are in surgery {L-5}. This risk does not suggest that manipulation should be excluded from the armamentarium of practice as several authors169,170 have hinted {L-5}.GDC The diagnosis (or assessment leading to diagnosis), treatment and reassessment steps of the decision algorithm in Figure 1 1.3.1. Informed consent The evidence suggests that informed consent is as important for younger and healthier patients as it is for others, because these patients bear a disproportionately high burden of dissection-related stroke {L-3b}157 {L-4}.153
1.3.2. Predispositions to dissection in a patient’s history Trauma The evidence suggests that a recent history of trauma may predispose to dissection {L-4}.149 Lifestyle Sex The evidence suggests that a person’s sex is not a determinant of non-traumatic VAD {L-4}.168 Non-vascular illnesses Vascular pathologies (excluding dissection or impaired vertebral artery flow) The evidence suggests that a history of vascular pathologies is not a definitive determinant of VAD {L-4},156 although it may be suggestive of risk; of the vascular pathologies that have been proposed as risks for dissection, the most clearly demonstrated have been tissue abnormalities of the cervical arteries {L-3b}171 {L-4},172 but the link between these abnormalities and dissection, and the practicality of pre-manipulatively identifying these remains elusive {L-5}.GDC Patients predisposed to dissection by these factors may seek chiropractic care for neck pain {L-5}.GDC Hyperhomocysteinemia and cervical artery dissection The evidence suggests that hyperhomocysteinemia is associated with CAD-173 or dissection-174 related stroke {L-3b}, but not CAD per se {L-3b},173 contradicting at least one extensive review.175 The role of 5, 10-methylenetetrahydrofolate reductase (MTHFR, a deficient enzyme form associated with hyperhomocysteinemia) is ambiguous {L-5};GDC it is not associated with dissection-related stroke (a mix of VAD and CAD) {L-3b}174 or non-dissection stroke {L-5},175 but it is associated with CAD-related stroke {L-3b}.174 Hyperhomocysteinemia may be associated with VAD, but results are too inconclusive at this time for this to have clinical importance {L-5}.GDC Historical predispositions; caution or contraindication? Together, the current evidence144,148–150,153,156,158,169,171–179 suggests that none of the predisposing factors hypothesized in the literature definitively predict a dissection-related “cerebrovascular ischemic event” {L-4},144 and, therefore, none is a contraindication to manipulation {L-5}.GDC However, other evidence suggests that caution should be exercised in treating patients with a history of trauma {L-4},149 a smoking habit {L-4}149 (especially among patients vulnerable to tobacco’s negative, cumulative vascular effects {L-4}),153 or known arterial tissue abnormalities {L-3b}171 {L-4}.172
1.3.3. Noting predispositions during physical examination; impaired vertebral artery flow Doppler identification of impaired vertebral artery flow The evidence of an extensive review of the literature suggests that a positive (impaired) Doppler “flow test” does not predict impaired vertebral artery blood flow {L-5}.146 Provocative identification of impaired vertebral artery flow Pre-manipulative vertebral artery function tests to identify patients with impaired flow have been part of practice knowledge since Smith and Eldridge introduced a test in 1962.147 Since then, several tests have been developed, and the vertebral artery flow effects180 of these are moderately well understood: Barré-Leiou’s sign test, George’s cerebrovascular craniocervical functional test, Maigne’s test, Hautant’s test, Underberg’s test, Dix-Hallpike maneuver (also known as Nylen’s or Barany’s maneuver), and deKleyn’s test.147 The most common is deKleyn’s test.147 The evidence suggests that a positive (impaired) provocative “flow test” rarely indicates changes in vertebral artery blood flow {L-4}147 and, consequently, deKleyn’s test is neither sensitive nor specific. Thus a positive test should not be an absolute contraindication to manipulation {L-5}.147 Other results {L-4} have also suggested pre-manipulative flow testing is unlikely to identify patients with flow impedances {L-5}.146 Observational identification of impaired vertebral artery flow (overt symptoms of VBI) We agree with the evidence defining the signs and symptoms of VBI (nystagmus, nausea, numbness, diplopia, drop attacks, dysphagia, dysarthria, ataxia),181 as differentiated from benign paroxysmal positional vertigo (BPPV) {L-5}.146 It is our understanding that these differentiated signs and symptoms may indicate the vertebral artery has an anatomic predisposition to dissection, has a narrow safety margin for the impairment of flow, or is dissected {L-5}. This suggests caution in proceeding with treatment when overt signs or symptoms of VBI are noted {L-5}.GDC
1.3.4. Dissection in the chiropractic clinic Identifying the occurrence of dissection before or during a visit We agree with at least 3 other reports153,162,182 that manipulation is contraindicated for patients with an active or existing VAD or CAD, although there have been uneventful case reports of manipulation being used with benefit in treating patients who have “recovered” from dissections.169,183
This is relevant because impaired vertebral artery flow can exhibit symptoms149,150,154 that may lead to the patient seeking chiropractic care {L-5};GDC VAD and CAD are associated with neck-pain and headache {L-4},99,149 although asymptomatic ICAD has been reported {L-5}.162 The evidence suggests that symptoms of impaired vertebral artery flow can lead patients to seek chiropractic care {L-4};149,156 and that in most patients with dissection-precipitated cerebral ischemia, the event of dissection161 – or the presence of dissection leading to stroke148,153 (specifically VAD)149,168,184 – is associated with neck or occipital pain with a sharp quality and severe intensity, or a severe and persistent headache, which is sudden and unlike any previously experienced pain or headache {L-4}. However, this pain may not be clearly distinguished from musculoskeletal or neuralgic pain {L-5}.144,153
Mitigating the harm of VAD; a stroke The full extent of identifying and managing the risk of stroke subsequent to VAD is beyond the scope of this CPG. However, we conclude that any sign of VAD should precipitate immediate referral to emergency health services {L-5}.GDC The evidence suggests that progression from VAD to stroke may be indicated by specific neurovascular signs or symptoms: unilateral facial paresthesia, objective cerebellar signs, lateral medullary signs, and visual field defects {L-4}.168 Vertigo is also cited,168 but we consider this to be a prevalent symptom of various less alarming syndromes, such as those with inner ear involvement {L-5}.GDC We agree with the text by Goetz185 that provides a more complete list of signs and symptoms {L-5}.
1.3.5 Recommendation summary
Appendix 2: Stroke; an adverse event of the rotation component of manipulation? (more detail in Appendix 17, technical version at http://ccachiro.org/cpg)
Stroke has been associated with chiropractic manipulation in the news media for some time. Reports associating chiropractic treatment with stroke rest on accepting a hypothetical 5-link chain: 1) manipulation may be associated with dissection or cervical artery intima injury with 2) possible clot formation at the site of injury, 3) from which emboli or thrombi may be shed, 4) which in-turn may occlude arteries feeding the brain, 5) possibly causing a full stroke. However, not all dissection leads to stroke, and not all stroke is the result of dissection.148,149,156–160 The evidence suggests that rotary manipulation is very popular but its role in precipitating cerebrovascular (CV) accidents remains unclear {L-5}.GDC On one hand, no particular manipulation technique predicts stroke {L-4},148 and no particular technique is disproportionately prevalent among manipulation-associated stroke patients {L-4}.156 On the other hand, rotation techniques applied to the upper-cervical spine are more associated with CV accidents than non-rotation or rotation to the mid- or lower-cervical spine {L-4},186 and upper-cervical manipulations of any type are 4 times more associated with cerebrovascular incidents (CVIs, transitional signs of possible CV accident) than lower-cervical manipulations {L-4}.187
2.1. Hyperhomocysteinemia as a risk for stroke or TIA The evidence that elevated plasma homocysteine concentrations (and the associated, reduced plasma concentrations of folate, vitamin B12 or vitamin B6 {L-1b}192 {L-2c})188–191 correlates with an increased risk of stroke is not conclusive {L-5}GDC – although some evidence directly suggests that specifically sub-optimal levels of vitamin B6, and not hyperhomocysteinemia, are associated with hypothesized increases in the risk of stroke or TIA {L-5}.193 Although the evidence is inconclusive, this suggests that patients presenting with known hyperhomocysteinemia should be treated with caution {L-5},GDC but not that an assay of homocysteine levels should be part of an assessment with healthy patients. 2.2. Stroke; predictors of this adverse event subsequent to manipulation The link between rotation manipulation and stroke is tenuous (above), and at least one study194 has reported that the maximal angular difference between the head and neck or trunk in the course of a rotation manipulation does not exceed the active physiologic range of motion {L-4}. However, we concluded that the risk factors for stroke should be accounted for in best practice patterns (Section 5). See Tables 3a to 3h for all identified risk factors that are absolute contraindications, Table 5 for all identified factors that require treatment caution, and Table 6 for stroke-specific risk factors that require treatment modality modification {L-5}. Section 5.3.2 clarifies the clinical meaning of modality modification.
Appendix 3 Evidenced, cervical pain benefit from chiropractic treatments
Footnotes Contributing advisors: Literature Search Team (treatment and dissection, all at CMCC, Toronto, ON): Carol Hagino, BSc, MBA; Janet Hayes RN, CCRP; Kim Humphreys, PhD, DC; Anne Taylor-Vaisey, MLS; Howard Vernon DC, PhD, FCCS(C). Literature Search Team (adverse events): Andrea Furlan, MD; Anne Taylor-Vaisey, MLS. Literature Search Team (treatment update): Anne Taylor-Vaisey, MLS. Evidence Extraction Team: Thor Eglington, MSc, RN (Ottawa, ON); Bruce P Squires, PhD, MD (Ottawa, ON). Critical commentary: Donald R Murphy, DC, DACAN (Rhode Island Spine Center, Department of Community Health, Brown University School of Medicine, Providence, RI, USA). Review Panel: Robert R Burton, BSc, DC, FCCRS(C), DACRB (St John’s, NL); Andrea Furlan, MD; Richard Roy, DC (Université du Québec à Trois Rivières, Trois Rivières, QC ); Steven Silk, BSc, DC (Wiarton, ON); Roy Till, DC, FCCRS(C) (Stoney Creek, ON). Task Force: Grayden Bridge, DC (President, The Canadian Chiropractic Association [The CCA]); H James Duncan, BFA, ex-officio (The CCA); Wanda Lee MacPhee, BSc, DC (President, Canadian Federation of Chiropractic Regulatory Boards [CFCRB]); Bruce Squires, BA, MBA (ex-officio, Ontario Chiropractic Association [OCA]); Greg Stewart, BPE, DC (The CCA); Keith Thomson, DC (CFCRB); Dean Wright, DC (ex-officio, President, OCA). Sources of support and sponsoring agency: This work was funded by an unrestricted grant provided by the Ontario Ministry of Health and Long-Term Care to the Ontario Chiropractic Association. This work was sponsored by The CCA and the CFCRB. Conflicts of interest: The contributing individuals declared no conflicts of interest. GDC members Andrea Furlan and Janice Gross Stein received a per diem for their participation. The literature search and evidence extraction teams were contracted. 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