Summary Sheet: Number 1

Summary sheet Country of origin: Israel

Methods

All patients attended the MS Centre, they were block randomised into groups by assignment of a sealed envelope containing either active or control.

Each patient received 45 minutes of treatment for 11 weeks either individualised Reflexology or non-specific calf massage.

36 Reflexologists were involved, each treating one active and one control patient (removes the argument that it’s the effect of the specific therapist that causes the results). The patients were informed they were going to receive either sole or calf Reflexology.

Clinical assessment was blinded and carried out before, at the onset of treatment, after 6 weeks, on completion and after an additional three months.

Outcome measurements were;

Paresthesia (areas of prickling or tingling on skin) – by Visual Analogue Scale (VAS)

Urinary symptoms - by American Urological Association symptom score

Muscle strength – by British Medical research Council (BMRC) scale.

Muscle tone – by Ashworth score.

An open pre-study had calculated the sample size. 20 patients had been treated for six weeks and the difference in intensity of paresthesia was evaluated. The sample size calculation for the study used a projected improvement in 30% of the active group and 5% in the control. They study size was then calculated at 70 patients split between the two groups.

Data analysis – by Wilcoxon rank test and Mann – Whitney test.

Results

Only patients completing the trial were entered into the results. 75% completed. There were no differences between the groups.

There were variations of symptoms amongst individual patients.

But comparison between the two groups showed statistically significant differences in the paresthesia (p= 0.01), urinary symptoms (p=0.03) and spasticity (p=0.03), while muscle strength showed only borderline improvement (p=0.06).

The difference in the intensity of the paresthesia continued between the groups after three months of follow up (p=0.04).

Conclusions

Reflexology resulted in an improvement of various symptoms of MS to a statistically significant level. No improvement was seen in the control group. Extraordinarily, the statistical improvement in spasticity and the statistically borderline improvement in muscle strength together are remarkable as the usual drug intervention for spasticity usually results in muscle weakness.

The treatment was safe with no adverse effects noted.

Comments

An excellent and positive study. The sample size was calculated in the first instance which makes it more possible to show a positive result if there is one to be detected.

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