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Cover of Evidence review for the clinical and cost-effectiveness of manual therapy for the management of osteoarthritis

Evidence review for the clinical and cost-effectiveness of manual therapy for the management of osteoarthritis

Osteoarthritis in over 16s: diagnosis and management

Evidence review E

NICE Guideline, No. 226

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-4740-9

1. Manual therapy

1.1. Review question

What is the clinical and cost-effectiveness of manual therapy for the management of osteoarthritis?

1.1.1. Introduction

The benefit of exercise for people with some forms of osteoarthritis is well established. Manual therapy may also help provide a benefit for some joints by increasing mobility and reducing pain. There are a variety of techniques including passive stretching, soft tissue techniques and acupressure/trigger point therapy.

There is no standard current practice relating to the provision of manual therapy for people with osteoarthritis, the use of this management approach is left to the discretion and expertise of the treating healthcare professional. As manual therapy needs to be delivered in a face-to-face context, there is potentially a resource implication for offering manual therapy in a system in which remote consultations are employed. This review aims to investigate the effectiveness of manual therapy (including passive and active mobilisation) and manual therapy plus exercise compared to exercise or no manual therapy in the management of osteoarthritis to establish whether manual therapy should be offered to people with osteoarthritis.

1.1.2. Summary of the protocol

For full details see the review protocol in Appendix A.

Table 1. PICO characteristics of review question.

Table 1

PICO characteristics of review question.

A range of non-pharmacological interventions have been reported to reduce joint pain and improve function. However, these interventions are not used consistently. This review aims to assess the clinical and cost-effectiveness of manual therapy (including passive and active mobilisation) in the management of osteoarthritis. A minimum duration of one week was thought relevant to ensure that the participants received more than one session of the intervention.

1.1.3. Methods and process

This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual. Methods specific to this review question are described in the review protocol in Appendix A and the methods document.

Declarations of interest were recorded according to NICE’s conflicts of interest policy.

1.1.4. Effectiveness evidence

1.1.4.1. Included studies

Fifteen randomised controlled studies were included in the review;1, 2, 5, 12, 32, 33, 48, 51, 55, 77, 82, 86, 87, 95, 105 these are summarised in Table 2. Evidence from these studies is summarised in the clinical evidence summaries below.

The clinical studies identified included the following comparisons:

  • Manual therapy compared to sham therapy
  • Manual therapy compared to no treatment
  • Manual therapy and exercise compared to exercise
  • Manual therapy and exercise compared to sham therapy
  • Manual therapy and exercise compared to no treatment

See also the study selection flow chart in Appendix C, study evidence tables in Appendix D, forest plots in Appendix E and GRADE tables in Appendix F.

Most of the studies were in combination with exercise and the majority of studies included participants with osteoarthritis of the knee.

1.1.4.2. Excluded studies

There were relevant systematic reviews, which did not meet the PICO for inclusion completely with the main difference being the comparators. The references were checked any studies that fulfilled the inclusion criteria were included.

See the excluded studies list in Appendix J.

1.1.5. Summary of studies included in the effectiveness evidence

Table 2. Summary of studies included in the evidence review.

Table 2

Summary of studies included in the evidence review.

See Appendix D for full evidence tables.

1.1.6. Summary of the effectiveness evidence

Table 3. Clinical evidence summary: manual therapy versus sham therapy.

Table 3

Clinical evidence summary: manual therapy versus sham therapy.

Table 4. Clinical evidence summary: manual therapy versus no treatment.

Table 4

Clinical evidence summary: manual therapy versus no treatment.

Table 5. Clinical evidence summary: manual therapy and exercise versus exercise.

Table 5

Clinical evidence summary: manual therapy and exercise versus exercise.

Table 6. Clinical evidence summary: manual therapy and exercise versus sham therapy.

Table 6

Clinical evidence summary: manual therapy and exercise versus sham therapy.

Table 7. Clinical evidence summary: manual therapy and exercise versus no treatment.

Table 7

Clinical evidence summary: manual therapy and exercise versus no treatment.

1.1.7. Economic evidence

1.1.7.1. Included studies

Three health economic analyses (from four papers) with all the relevant comparisons were included in this review.3, 72, 81, 85 These are summarised in the health economic evidence profile below (Table 8) and the health economic evidence tables in Appendix H.

1.1.7.2. Excluded studies

No relevant health economic studies were excluded due to assessment of limited applicability or methodological limitations.

See also the health economic study selection flow chart in Appendix G.

1.1.8. Summary of included economic evidence

Table 8. Health economic evidence profile: Manual therapy.

Table 8

Health economic evidence profile: Manual therapy.

1.1.9. Economic model

This area was not prioritised for new cost-effectiveness analysis.

1.1.10. Unit costs

Relevant unit costs are provided below to aid consideration of cost effectiveness.

ResourceUnit costs (cost per hour)(a)Source
Community physiotherapist including training costs (band 5/6/7)£38/£50/£60PSSRU 202039
(a)

Including qualification costs

1.1.11. Economic evidence statements

  • One cost-utility analysis reported that supervised group exercise therapy alone dominated both manual therapy alone and manual therapy and exercise therapy combined. This analysis was graded as partially applicable with potentially serious limitations.
  • One cost-utility analysis reported that supervised exercise alone over one year was cost effective compared with supervised exercise alone over nine weeks (ICER: £3,100). Supervised exercise alone over one year also dominated supervised exercise plus manual therapy over nine weeks and supervised exercise plus manual therapy over one year. However, manual therapy plus exercise over nine weeks was cost effective versus manual therapy alone over nine weeks. This analysis was graded as partially applicable with potentially serious limitations.
  • One cost utility analysis that was based on three separate network meta-analyses reported that manual therapy was cost effective compared with usual care in only one of the three analyses (ICER; £15,389 when only trials with a low risk of bias for allocation concealment with outcomes between 3–13 weeks were included. A full incremental analysis of various non-pharmacological interventions (acupuncture, braces, heat treatment, insoles, interferential therapy, laser/light therapy, manual therapy, neuromuscular electrical stimulation, pulsed electromagnetic field, pulsed electrical stimulation, static magnets and transcutaneous electrical nerve stimulation) also reported that acupuncture was the most cost-effective strategy in two of the three network meta-analyses (£13,502 and 14,275), with transcutaneous electrical nerve stimulation the most cost-effective option in the other (£2,690). The analysis was assessed as directly applicable with potentially serious limitations.

1.1.12. The committee’s discussion and interpretation of the evidence

1.1.12.1. The outcomes that matter most

The critical outcomes were quality of life, pain and physical function. These were considered critical due to their importance to people with osteoarthritis. The Osteoarthritis Research Society International (OARSI) consider that pain and physical function were the most important outcomes for evaluating interventions. Quality of life gives a broader perspective on the person’s wellbeing, allowing for examination of the biopsychosocial impact of interventions. Psychological distress, osteoarthritis flare and minor adverse events and moderate/major adverse events were included as important outcomes.

The committee considered osteoarthritis flares to be important in the lived experience and management of osteoarthritis. However, these were also considered difficult to measure with no clear consensus on their definition. The Flares in OA OMERACT working group have proposed an initial definition and domains of OA flares through a consensus exercise; “it is a transient state, different from the usual state of the condition, with a duration of a few days, characterized by onset, worsening of pain, swelling, stiffness, impact on sleep, activity, functioning, and psychological aspects that can resolve spontaneously or lead to a need to adjust therapy”. However, this has been considered to have limitations and has not been widely adopted. Therefore, the committee included the outcome accepting any reasonable definition provided by any studies discussing the event.

Mortality was included as a treatment adverse event rather than as a discreet outcome and categorised as an important outcome. Osteoarthritis as a disease process is not considered to cause mortality by itself and mortality is an uncommon outcome from osteoarthritis interventions.

There was evidence available for all outcomes apart from osteoarthritis flares. However, while some data was available, there was only limited evidence available for psychological distress and adverse events throughout the literature.

1.1.12.2. The quality of the evidence

Fifteen studies were included in this review. The comparisons where evidence was present included:

  • Manual therapy compared to sham therapy
  • Manual therapy compared to no treatment
  • Manual therapy and exercise compared to exercise
  • Manual therapy and exercise compared to sham therapy
  • Manual therapy and exercise compared to no treatment

The evidence varied from high to very low quality due to a mixture of risk of bias, imprecision and inconsistency. The committee concluded that the amount of evidence had increased since the previous version of the guideline. However, the quality of that evidence had not improved. While some studies had more participants than previous studies, the blinding was often inadequate and allocation concealment was not well reported. Inconsistency led to issues in comparisons where more evidence was available, with some studies showing significantly larger benefits than others. The reasons for this heterogeneity could not be explained by subgroup analyses agreed in the protocol.

Manual therapy compared to sham therapy

The evidence for this comparison ranged from moderate to very low quality due to a mixture of imprecision and inconsistency, where heterogeneity could not be resolved by subgroup analysis. Risk of bias was mostly due to a mixture of selection (due to inadequate reporting of allocation concealment).

Manual therapy compared to no treatment

The evidence for this comparison ranged from moderate to very low quality due to a mixture of risk of bias, imprecision and inconsistency, where heterogeneity could not be resolved by subgroup analysis. Risk of bias was mostly due to a mixture of selection (due to inadequate reporting of allocation concealment and/or differences in baseline values between study arms) and performance bias (due to inadequate blinding of participants and outcome assessors).

Manual therapy and exercise compared to exercise

The evidence for this comparison ranged from moderate to very low quality due to a mixture of risk of bias, imprecision and inconsistency, where heterogeneity could not be resolved by subgroup analysis. Risk of bias was mostly due to a mixture of selection (due to inadequate reporting of allocation concealment) and performance bias (due to inadequate blinding of participants and outcome assessors).

Manual therapy and exercise compared to sham therapy

The evidence for this comparison was reported in one study with 60 participants and included one outcome, pain at less than or equal to 3 months. The quality of this outcome was high.

Manual therapy and exercise compared to no treatment

The evidence for this comparison ranged from moderate to very low quality due to a mixture of risk of bias, imprecision and inconsistency, where heterogeneity could not be resolved by subgroup analysis. Risk of bias was mostly due to a mixture of selection (due to inadequate reporting of allocation concealment), performance (due to inadequate blinding of participants and outcome assessors) or attrition bias (due to incomplete outcome data being available).

1.1.12.3. Benefits and harms
Key uncertainties

The committee acknowledged that while there was more evidence then when the review was conducted in the previous version of the guideline, the evidence was limited due to higher risk of bias in included studies and the presence of imprecision. This was linked to the small number of participants in studies. The committee concluded that the limitations in study design made it difficult to determine the effect of manual therapy.

The committee discussed that generally the adverse events data for these trials was limited as this was generally found in small studies with a short follow up time and so it is unclear whether this is representative of the events expected to be seen in real life practice. Given this, the committee considered the evidence for serious adverse events to be unclear throughout the review reflecting this in their weighting of findings while making recommendations. The committee noted throughout the evidence that the number of adverse events was often low and where events were reported they were transient in nature (such as increased pain). Given this, while the committee acknowledged where clinically important differences were highlighted in the evidence, but also considered the nature and true number of these events.

Manual therapy compared to sham therapy

Evidence from this comparison was reported in studies where at most 222 participants were present in the outcomes. The evidence showed a clinically important benefit in quality of life at >3 months for the SF-36 mental component only, pain at ≤3 and >3 months and physical function at ≤3 months. No clinically important difference was seen in quality of life at ≤3 months for the SF-36 mental component only, quality of life at >3 months for the SF-36 physical component and physical function at >3 months. A clinically important harm was seen in quality of life at ≤3 months for the SF-36 physical component only.

Manual therapy compared to no treatment

Evidence for this comparison included more studies where at most 331 participants were present in the outcomes. The evidence showed clinically important benefits in quality of life at >3 months, pain at ≤3 and >3 months and physical function at ≤3 and >3 months. There were unclear effects where some outcomes showed clinically important benefits while others showed no clinically important difference in quality of life at ≤3 months and psychological distress at ≤3 and >3 months. No clinically important difference in moderate/major adverse events at >3 months was seen. However, a clinically important harm in minor adverse events at ≤3 months was seen (based on one small study with 35 participants).

Manual therapy and exercise compared to exercise

Evidence for this comparison was reported in a larger number of studies. However, the number of participants included in an outcome was at most 320 participants. The evidence showed an unclear effect on pain at ≤3 months. One outcome (including a change score) including one study with 150 participants but of moderate quality showed a clinically important benefit of exercise alone, while another outcome (including final values) including four studies with 320 participants but of very low quality showed clinically important benefits of manual therapy and exercise. Otherwise no clinically important differences were seen in quality of life at ≤3 months, pain at >3 months, physical function at ≤3 and >3 months, psychological distress at ≤3 months and moderate/major adverse events at >3 months.

Manual therapy and exercise compared to sham therapy

Evidence for this comparison was reported in one study with 60 participants. The only outcome reported was pain at ≤3 months which showed a clinically important benefit of manual therapy and exercise. This was based on high quality evidence. The committee acknowledged that the evidence for this comparison was difficult to interpret due to the potential effect that exercise alone may have on the result.

Manual therapy and exercise compared to no treatment

Evidence for this comparison was reported in more studies. However, the number of participants included in an outcome was at most 311 participants. The evidence showed clinically important benefits of manual therapy and exercise in quality of life at >3 months, pain at ≤3 and >3 months and physical function at >3 months. However, the evidence showed no clinically important differences in quality of life at ≤3 months, physical function at ≤3 months, psychological distress at ≤3 months and moderate/major adverse events at >3 months. The committee acknowledged that the evidence for this comparison was difficult to interpret due to the potential effect that exercise alone may have on the result.

Weighing up the clinical benefits and harms

On considering this evidence, the committee acknowledged that while there were some benefits due to manual therapy this was often in outcomes that were imprecise or heterogenous with inconsistency that could not be resolved by subgroup analysis. Due to the nature of this, the committee concluded that there was insufficient evidence to indicate a benefit from manual therapy alone. However, there was evidence of benefit for manual therapy when combined with exercise that may the benefit from exercise alone in pain The committee acknowledged the uncertainty in the outcomes for this, but overall agreed that manual therapy when combined with exercise could be considered for people with osteoarthritis. This may be appropriate for people who are finding it difficult to start exercise alone.

Given this the committee recommending that manual therapy should only be considered for people with knee and hip osteoarthritis, delivered in combination with exercise and that people should be informed that there is insufficient evidence for manual therapy alone. The committee found that the majority of evidence was at less than 3 months with the average amount of time that manual therapy was provided for being seven weeks. Given this, the committee agreed that manual therapy should be provided in the short term to help people to start exercise if they were finding this difficult without additional intervention. However, they recommended that further research was required to understand this more and provide evidence for joint sites other than hip and knee osteoarthritis (see research recommendations).

1.1.12.4. Cost effectiveness and resource use

Manual therapy may be delivered by physiotherapists, chiropractors or osteopaths in the NHS.

Three economic evaluations were identified in the review. One economic evaluation showed that for people with hip and knee osteoarthritis, supervised group exercise therapy alone dominated both manual therapy alone and manual and exercise therapy combined.

A second economic evaluation took a UK perspective and was based on three separate network meta-analyses of randomised controlled trials (RCTs); one analyses was based on all eligible trials, one was confined to only those trials that utilised adequate allocation concealment and the final analyses further limited the trials to include those with a adequate allocation concealment and an end point reported at 3–13 weeks. QALYs were calculated by mapping from various measures to EQ-5D and then pooling the results to give an overall estimate. It was deemed to be directly applicable. The model time horizon was relatively short at 8 weeks. The unit costs were taken from 2011/12 and were therefore unlikely to be representative of current NHS practice. For these reasons, it was graded as having potentially serious limitations.

The analysis compared various non-pharmacological interventions to usual care (acupuncture, braces, heat treatment, insoles, interferential therapy, laser/light therapy, manual therapy, neuromuscular electrical stimulation (NMES), pulsed electromagnetic field (PEMF), pulsed electrical stimulation (PES), static magnets and transcutaneous electrical nerve stimulation (TENS)). Manual therapy was not cost effective versus usual care at a cost per QALY gained threshold of £20,000 in two of the three analyses; the analysis that considered all trials as well as the analysis that limited to trials to those with suitable allocation concealment. In the analysis that confined trials to those with suitable allocation concealment as well as an end point at 3–13 weeks, manual therapy was cost effective versus usual care with a cost per QALY reported of £15,389.

In a full incremental analysis, TENS was the most cost-effective option in an analysis of all trials with a cost per QALY gained of £2,690. However, acupuncture was the most cost-effective option in an analysis of trials with a low risk of bias for allocation concealment and trials with a low risk of bias for allocation concealment with outcomes between 3–13 weeks with costs per QALY gained of £13,502 and £14,275, respectively.

The final economic evaluation had a New Zealand perspective. The analysis was based on a single randomised controlled trial of 75 participants with four comparators: supervised exercise alone over nine weeks, supervised exercise alone over one year, supervised exercise plus manual therapy over nine weeks and supervised exercise plus manual therapy over one year. The sources of costs that were used during the analysis were unclear. This evaluation was graded as partially applicable with potentially serious limitations. The most cost-effective intervention was supervised exercise alone over nine weeks with a cost per QALY gained of £3,100 versus supervised exercise alone over nine weeks. This option also dominated both interventions with manual therapy included, being cheaper and more effective. However, manual therapy plus exercise delivered over nine weeks was cost effective versus manual therapy alone over nine weeks.

The cost effectiveness evidence from these three studies was mixed overall. The committee concluded that manual therapy could be cost effective as an adjunct to exercise but not by itself. It therefore recommended that manual therapy be considered as an adjunct to therapeutic exercise in people with osteoarthritis of the hip, knee, or hand.

1.1.12.5. Other factors the committee took into account

The committee also considered the delivery of manual therapy. Manual therapy would be delivered by healthcare professionals including physiotherapists, chiropractors and osteopaths. Treatment is typically individual and delivered face to face. The committee acknowledged that this may be challenging in current practice due to changes following the COVID-19 pandemic. The committee noted that some evidence reported people being taught to deliver manual therapy to themselves, which may be a way to resolve some of the challenges from this. However, further research would be required to ensure that self-administered manual therapy is as effective as manual therapy delivered by a healthcare professional. This was incorporated in research recommendation.

The committee noted that the research identified does not appear to represent the diverse population of people with osteoarthritis. They agreed that any further research should be representative of the population, including people from different family backgrounds, and socioeconomic backgrounds, disabled people, and people of different ages and genders. Future work should be done to consider the different experiences of people from diverse communities to ensure that the approach taken can be made equitable for everyone. With this in mind the committee subgrouped their research recommendation by these protected characteristics where appropriate while suggesting that people from each group should be included in the research to ensure that it is applicable to the entire population.

1.1.13. Recommendations supported by this evidence review

This evidence review supports recommendations 1.3.6 to 1.3.7 and the research recommendation on manual therapy. Other evidence supporting these recommendations can be found in evidence review E.

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Appendices

Appendix A. Review protocols

Review protocol for manual therapy (PDF, 246K)

Appendix B. Literature search strategies

  • What is the clinical and cost-effectiveness of manual therapy for the management of osteoarthritis?

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.75

For more information, please see the Methodology review published as part of the accompanying documents for this guideline.

B.1. Clinical search literature search strategy (PDF, 147K)

B.2. Health Economics literature search strategy (PDF, 150K)

Appendix D. Effectiveness evidence

Download PDF (379K)

Appendix G. Economic evidence study selection

Download PDF (153K)

Appendix H. Economic evidence tables

Download PDF (209K)

Appendix I. Health economic model

No original economic modelling was undertaken.

Appendix J. Excluded studies

Clinical studies

Download PDF (122K)

Health Economic studies

Published health economic studies that met the inclusion criteria (relevant population, comparators, economic study design, published 2005 or later and not from non-OECD country or USA) but that were excluded following appraisal of applicability and methodological quality are listed below. See the health economic protocol for more details.

None.

Appendix K. Research recommendations – full details

K.1. Research recommendation

What is the clinical and cost-effectiveness of manual therapy for people with osteoarthritis, when used alone and when used in combination with therapeutic exercise?

K.2. Why this is important

In this review, manual therapy in combination with therapeutic exercise was shown to likely be clinically and cost-effective. However, the evidence for this was based on a limited number of small trials of low quality. There was limited evidence for the clinical and cost-effectiveness of manual therapy used alone, which came from studies that were of low quality, with insufficient blinding and allocation concealment and with some imprecision. Given this, further research that was sufficiently well powered and of high quality would be important to be more certain of the benefits of manual therapy and whether it is only effective when combined with exercise or whether it is effective without exercise.

K.3. Rationale for research recommendation

Download PDF (100K)

K.4. Modified PICO table

Download PDF (175K)

Final

Evidence reviews underpinning recommendations 1.3.6 to 1.3.7 and research recommendations in the NICE guideline

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Copyright © NICE 2022.
Bookshelf ID: NBK590293PMID: 37036920

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