EVIDENCE TABLES

Bloomfield DM (2002) Strategy for the management of vasovagal syncope. Drugs & Aging 19, 179–202.
Design: Expert Review, Evidence level 4

Aim: This review described the diagnosis and treatment of vasovagal syncope. It included specific areas such as;
Inclusion criteria
  • Any study types that are relevant to this topic.
  • There was no systematic search of the literature
  • There was not systematic grading of included evidence, although comments were made that reported the overall evidence body
Population
Individuals who suffer from disorders of autonomic control associated with orthostatic intolerance (which are a diverse group of syndromes) that can result in syncope and near-syncope.
Interventions
Outcomes
Results
The results reported in this review about the effectiveness of Fludrocortisone were presented in a narrative format. Essentially there is limited evidence (as reported by this review), one RCT comparing Fludrocortisone with atenolol and consensus support for the use of this drug.
  • Data supporting the value of fludrocortisone for the treatment of vasovagal syncope are extremely limited, although fludrocortisone is widely used and often considered one of the first lines of therapy for this condition.
  • No randomised placebo controlled studies have assessed the efficacy of fludrocortisone in preventing recurrences of vasovagal syncope.
  • Two small studies have evaluated fludrocortisone in paediatric patients (Scott 1995, Grubb 1992).
  • Fludrocortisone may not be well tolerated in elderly patients
References of Included Studies
Scott WA, Pongiglione G, Bromberg BI, et al. Randomized comparison of atenolol and fludrocortisone acetate in the treatment of pediatric neurally mediated syncope. Am J Cardiol 1995; 76: 400-2

Grubb BP, Temesy-Armos P, Moore J, et al. The use of head upright tilt table testing in the evaluation and management of syncope in children and adolescents. PACE 1992; 15: 742-8

Bloomfield DM, Sheldon R, Grubb BP, et al. Putting it together: a new treatment algorithm for vasovagal syncope and related disorders. Am J Cardiol 1999; 84 (8A): 33Q-9Q
Claydon VE (2006) Orthostatic hypotension following spinal cord injury: Understanding clinical pathophysiology. Spinal Cord 341–351.
Design: Expert, Unsystematic review, evidence level 4

Aim: The aim of this review is to outline the incidence and patho-physiological mechanisms underlying the orthostatic hypotension that commonly occurs following SCI. The aetiology of this condition is described. The management of orthostatic hypotension is also examined.
Inclusion criteria
Not described
Exclusion criteria
Not described
Population
Patients who have SCIs
Interventions
Outcomes
Results
Compression bandages:
As quoted from the review:
“The use of compression bandages or support stockings to restrict venous pooling in the visceral area and dependent limbs should be encouraged”
[this review did cite 3 other studies that also presented evidence but these citations were other unsystematic review articles]

Fludrocortisone
  • Reference was made to the mechanism of action of this drug and listed as a strategy for the management of hypotension in SCI patients.
  • 2 other refs were also cited but on further inspection of these citations, one was a single case study and the other a low grade comparative study with 6 patients with hypoadrenergic orthostatic hypotension.
General comments
The evidence about the management of orthostatic hypotension is presented in a narrative format. All the evidence included in this review was of low grade with no RCTs cited.
Faghri PD (2002) Electrically induced and voluntary activation of physiologic muscle pump: A comparison between spinal cord-injured and able-bodied individuals. Clinical Rehabilitation 878–885.
Design: Comparative, non-randomised, evidence level 2−
Country: USA

Aim: The purpose of the present study was to compare the haemodynamic responses of stroke volume, cardiac output, blood pressure, total peripheral resistance and heart rate to changes in position from sitting to standing and during 30 min of stationary standing between able-bodied and spinal cord-injured participants.
Inclusion criteria
spinal cord-injured individuals
Exclusion criteria
  • Individuals with cardiac problem, pacemaker, recent fracture, incompetence uncontrolled spasticity and venous thrombosis within the last four weeks were excluded from the study.
  • Individuals were excluded from the study if the Doppler ultrasound examination revealed evidence of a venous insufficiency or deep venous thrombosis.
Population
  • 14 healthy spinal cord-injured individuals (C3–T12, ASIA criteria) were recruited
  • Mean age 29 ± 6 years, weight 70 ± 15 kg and height 170 ± 8 cm
Interventions
  • Participants were used as their own control.
  • All participants participated in two testing conditions on two separate days:
    1. stationary standing, defined as standing without any intervention for 30 min and
    2. dynamic standing, defined as standing utilizing FES during 30 min of standing for spinal cord-injured participants and performing voluntary tiptoe contractions during 30 min for able-bodied participants.
  • The two testing conditions were at least 24 hours apart for each participant, and the order of testing was random (by tossing a coin)
Outcomes
Results
  • During stationary standings, when participants moved from sitting to standing, spinal cord-injured participants showed significant reductions in systolic blood pressure, diastolic blood pressure and mean arterial pressure, while these values were maintained in able bodied participants (p<0.05).
  • During dynamic standing in which FES-induced contractions of the muscles started in spinal cord-injured participants while they were sitting and continued until standing, all of the blood pressure values were maintained to pre-standing values. There were no changes in any of these variables in able-bodied participants during change in position from sitting to standing.
Percentage changes in the haemodynamic values from standing at time zero were compared with 5 and 30 min of standing during all the standing sessions (stationary and dynamic).
  • During stationary standing in spinal cord-injured subjects, there were significant reductions in all of the haemodynamic values except for significant increases in total peripheral resistance at 5 and 30 min of standing.
  • During dynamic standing in spinal cord-injured subjects, at 5 min, there were no changes in any of the haemodynamic variables.
  • Following 30 min of this standing, while subjects maintained all the blood pressure values to pre-standing values, there were significant increase in heart rate and reduction in stroke volume (p<0.05).
Cardiac output was maintained and no changes were observed in total peripheral resistance.
  • During stationary standing by able-bodied subjects there were significant reductions in stroke volume, cardiac output and an increase in total peripheral resistance following 30 min.
  • During dynamic standing able-bodied subjects maintained all of their haemodynamic values at 5 min, however, following 30 min, cardiac output decreased while heart rate and total peripheral resistance increased.
General comments
Frisbie JH (2004) Postural hypotension, hyponatremia, and salt and water intake: Case reports. Journal of Spinal Cord Medicine 133–137
Design: Case series, Evidence level 3
Country: US

Aim: This study examined whether salt and water intake correlated with the severity of postural hypotension (PH)
Inclusion criteria
Exclusion criteria
Population
Participants were 4 patients with tetraplegia, motor and sensory complete, aged 68 to 83 years, who were paralyzed for 9 to 54 years, who had PH. These patients were ranked by the amount of ephedrine prescribed on a daily basis to treat PH over the preceding 2-year period.
Interventions
salt and water intake
Outcomes
The total urinary output of sodium and water and the effect of orthostasis on urine output rate, osmolality, sodium concentration, and creatinine secretion were determined over a 48-hour period of collection and compared with severity of PH.
Results
  • The ephedrine requirements, in order of decreasing severity of PH:
    100 mg/d, 25 mg/d, 12.5 mg/d, and no ephedrine needed.
  • The 24-hour sodium excretions in order of decreasing severity of PH:
    50, 92, 180, and 164 mEq.
  • The urine volumes were 1.4, 3, 2.6, and 5.4 L, respectively.
  • In the same order of decreasing PH severity, the sitting position relative to the recumbent position was characterized by increasing rates of creatinine secretion (ratios of 0.69, 0.74, 0.95, and 0.80), increasing rates of water excretion (ratios of 0.49, 0.28, 0.69, and 0.99), decreasing urine osmolality (ratios of 1.2, 1.8, 1.3, and 0.8), and increasing sodium concentrations (ratios of 0.9, 1.3, 1.2, and 2.6).
General comments
In individuals with tetraplegia, severe PH was accompanied by avid conservation of water and impaired retention of sodium in the sitting position, as well as limited salt and water intake.

This is a very small observational study presenting very limited evidence about whether salt and water intake correlated with the severity of postural hypotension. In order to understand this process the study would need to have included several more participants and conducted a controlled study.
Rimaud D, Calmels P, Roche F, Mongold JJ, Trudeau F, Devillard X (2007) Effects of graduated compression stockings on cardiovascular and metabolic responses to exercise and exercise recovery in persons with spinal cord injury. Archives of Physical Medicine & Rehabilitation 88, 703–709.
Design: Comparative, non randomised study, evidence level 2−
Country: Physical medicine and rehabilitation department in France

Aim: To investigate whether reporting blood redistribution by means of graduated elastic stockings affects exercise and post exercise responses in people with spinal cord injury (SCI).
Inclusion criteria
men with traumatic SCI
Exclusion criteria
Population
Fourteen men with traumatic SCI, grouped according to their level of injury.
Interventions
Participants performed 2 maximal wheelchair exercise tests 1 week apart, in random order and under a counter-balanced design. One test was done with and the other without graduated elastic stockings (21 mmHg).
Outcomes
  • Blood lactate, blood pressure, heart rate, maximal power output, and oxygen consumption (Vo2).
  • BP was reported in detail as it was the relevant outcome measure listed in the PICO.
Results
Different systolic blood pressure (SBP) were recorded according to conditions, injury level and exercise.
  • For low-level group; a significantly higher SBP at rest with the stockings on than without them (139±24mmHg vs 126±16mmHg, P<0.05)
  • For high-level group: lower SBP at rest was recorded with stockings than without (132±20mmHg vs 141±12 mmHg, no significant difference)
  • SBP was significantly lower at rest without stockings in the low-level group that in the high-level group (P<0.05)
  • Under both conditions, SBP increased at the end of the test in the low-level group (126±16mmHg at rest 141±38mmgHg at peak exercise without stockings: 139± 24mmH to 144± 40mmHg with, not significantly different).
  • Compared to; post exercise, SBP dropped in the high level group even with stockings (141±12mmHg at rest to 127±21mmHg at peak exercise without the stockings: 132±20mmHg to 119±37mmHg with the stockings, no significant difference)
  • Post exercise venous lactate concentration was reduced in SCI participants with lesion levels below T6 while wearing graduated elastic stockings during both exercise and recovery (10.9+/−3.9 mmol/L vs 12.5+/−4.6 mmol/L, P<0.05).
  • There were no significant differences in sub-maximal and maximal values (heart rate, Vo2, power output) between participants tested with and without graduated elastic stockings
General comments
Wearing elastic stockings affects post exercise responses by decreasing lactate concentration in well-trained, low-level paraplegic patients after a maximal exercise. The relatively low pressure generated by the stockings may not, however, influence the venous system enough to produce improved performance and cardiovascular responses.

Applicability of this study is limited due to the lack of comparability of the participant group with MSCC patients.
Svensson M, Siosteen A, Wetterqvist H, Sullivan L (1995) Influence of physiotherapy on leg blood flow in patients with complete spinal cord injury lesions. Physiotherapy Theory and Practice 11, 97–107.
Design: Before and After study (observational), evidence level 2−
Country: Sweden

Aim: To examine the effects of passive leg movements on lower limb blood flow in acute SCI patients, post injury.
Inclusion criteria
Patients with traumatic SCI
Exclusion criteria
Patients with cardiovascular disease or any other condition that would affect the study outcomes.
Population
  • 6 patients with traumatic SCI
  • Aged b/n 18–71 (median 24) years
  • Level of injury varied from C5 to T8
  • 3 were tetraplegic, 3 paraplegics
Interventions
5 and 30 movement series of exercises over 4 weeks – maximal passive flexion- extension in all joints of the leg with hip flexion limited to 70 ° in order to avoid movements of the pelvis and spine.
  • Resting blood flow was taken prior to tx.
  • One leg of each patient, always the same, was treated with the 5 movement and then 30 movement series. The contralateral leg remained untreated and not moved at all.
  • Measurements were taken after 5 movement series and the after the 30 movement series.
Outcomes
  • Arterial blood flow (recorded by venous occlusion plethysmography)
  • Skin blood flow (recorded by laser-Doppler)
  • Skin Temperature
Results
Arterial blood flow
  • Comparison of the treatments involving 5 and 30 repetitions showed approx. the same relative increase in blood flow.
In the treated leg:
  • 5 passive leg movements resulted in a mean increase of 0.37±26ml/100g/min
  • 30 movements resulted in a mean increase of 0.19±0.25ml/100g/min
In the untreated leg:
  • 5 passive leg movements resulted in a mean increase of 0.29 ±0.31 ml/100g/min
  • 30 movements resulted in a mean increase of 0.21± 0.22ml/100g/min

    The increase in blood flow was lower after treatment with 30 movements compared to 5 movements.

  • In the first week of measurement: blood flow increased significantly after 5 movements in both treated and untreated leg (P<0.05).
  • No other significant differences were reported when pre- and post treatment blood flow were compared.
Skin Blood Flow
In the treated leg:
  • 5 passive leg movements resulted in a mean increase in skin blood flow of 2.6±1.68%
  • 30 movements resulted in a mean increase in skin blood flow of 1.3 ±1.1%
In the untreated leg:
  • 5 passive leg movements resulted in a mean increase in skin blood flow of 2.2±2.36%
  • 30 movements resulted in a mean increase in skin blood flow of 0.6±0.52%

    The increase was lower after the 30 movement series the after the 5 movement series.

The increase in skin blood flow was significant in the treated leg after 5 passive leg movements during the first week of measurements, other differences recorded were not stat significant.

Skin Temperature
In the treated leg:
  • 5 passive leg movements resulted in a mean increase in temp of 0.9± 1.0°C
  • 30 movements resulted in a mean increase in temp of 0.03± 0.3°C
In the untreated leg:
  • 5 passive leg movements resulted in a mean increase in temp of 1.07± 1.2°C
  • 30 movements resulted in a mean increase in temp of 0.5 ± 0.3°C

    Out of 74 temperature measurements recorded, 48 indicated an increase.

General comments
This low quality evidence indicated that an increase in blood flow was slight or absent after treatment and there was no difference between the 5- and 30-movement series. The parameters studied did not indicate any useful effects of passive leg movements in the prevention of thrombosis in acute SCI patients.
Ter WW, De Groot PC, van Kuppevelt DH, Hopman MT (2006) Passive leg movements and passive cycling do not alter arterial leg blood flow in participants with spinal cord injury. Physical Therapy 86, 636–645
Design: Comparative, non-randomised study. Evidence level 2−

Aim: The purpose of this study was to assess peripheral circulatory responses during and after passive leg movements and passive cycling in participants with SCI (and control participants who were healthy by using protocols like those used in the clinical setting in rehabilitation centres.)
Inclusion criteria
All of the participants with SCI had motor complete lesions (American Spinal Injury Association class A or B) with injury levels between T2 and L1, and time since injury varied from 1 to 17.5 years
All participants were between 20 and 49 years of age and had no history of diabetes, cardiac diseases, recent DVT, or recent pressure ulcers.
Exclusion criteria
Population
  • 8 men with SCI and 8 male participants who were healthy (control participants)
Interventions
  • Passive leg movements carried out by a physical therapist and passive cycling (2 forms of passive exercise)
  • The tests were performed between 8:30 am and 1:00 pm.
  • The same investigator performed the test procedures, and passive leg movements were applied by 1 physical therapist in exactly the same sequence and manner for all participants.
  • Successively, each participant underwent 2 interventions, which consisted of passive leg movements and passive cycling.
Outcomes
  • Leg blood flow (LBF) at rest, during and after 10 minutes of standardized passive leg movements, and during and after 20 minutes of passive leg cycling (Echo Doppler measurements)
  • Blood pressure was measured continuously
  • Total peripheral resistance (TPR)
  • Leg vascular resistance (LVR)
  • Mean arterial pressure (MAP)
  • Cardiac output (CO)
For the variables LBF, LVR, TPR, MAP, and CO, 2-factor repeated-measures analyses were applied with time (rest, intervention, and recovery values) as the within-participant factor and group (SCI and control) as the between participant factor. The level of statistical significance for all tests was set at P<0.05.
Results
Resting Properties:
  • At supine rest, the arterial diameter and blood flow of the common femoral artery were decreased significantly in participants with SCI compared with control participants.
  • The LVR in participants with SCI was significantly higher than that in control participants.
  • No differences between the groups were seen in any other variable at rest.
Passive Leg Movements:
  • Repeated-measures analyses were applied to the data, and no significant main effect was found for blood flow
  • (P=0.68), LVR (P=0.71), TPR (P=0.59), MAP (P=0.46), or CO (P=0.65), indicating that the variables did not change over the time period examined.
  • No significant effect of an interaction of group and time was found for blood flow (P=0.35), LVR (P=0.22), TPR (P=0.68), or MAP (P=0.57).
Passive Leg Cycling:
  • Repeated-measures analyses revealed no changes over time for blood flow (P=0.14), LVR (P=0.34), TPR (P=0.59), MAP (P=0.37), or CO (P=0.84).
  • No significant effect of an interaction of group and time was found for blood flow (P=0.68), LVR (P=0.35), TPR (P=0.35), MAP (P=0.57), or CO (P=0.83).

From: Chapter 7, Supportive Care

Cover of Metastatic Spinal Cord Compression
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