Randomized Clinical Trial (RCT) on the effect of reflexology in the management of patients suffering from diabetic neuropathy: Case studies

A two armed, randomized, parallel group clinical trial was conducted to determine the effect of Reflexology in addition to the pharmacological drugs for managing patients suffering from peripheral neuropathy associated with diabetes mellitus. The patients were selected for this trial following the patients selection criteria and the ethical norms of the All India Institute of Medical Sciences. They were referred by the Outpatient Departments of Neurology & Endocrinology, All India Institute of Medical Sciences. A sample size of 71 patients of both genders were recruited during the year 2006 to 2009 for this trial. The intervention therapy (Reflexology) procedure was performed in the Department of Biophysics. A group of 18 patients was withdrawn from the trial. Thus the study group contains a sample size of 29 [mean age in years (mean ± SD) 56.75 ± 9.65 and duration of diabetes in years (median (range)) 10 (3-28) and duration of neuropathy in years (median (range)) 3 (0.5-8)]. The control group is comprised of sample size 29 [mean age in years (mean ± SD) 55.89 ± 11.21 and duration of diabetes in years (median (range)) 13 (4-30) and duration of neuropathy in years (median (range)) 6 (2-14)]. The sample size of this trial was calculated anticipating 20% mean reductions in neuropathy in the study group patients compared with the conventional one with 5% Level of significance and 80% power. Using statistical analysis software STATA 9.0 (College station, Texas, USA) the sample size was estimated to be 25 per group. We studied a sample size of 29 per group assuming 10% lost to follow up. Reflexology therapy was applied with the hypothesis that it would bring back and maintain homoeostasis amongst the internal body organ functions, harmonize all the endocrine glands functions and rectify the symptoms associated with diabetes. The working principle of the acupressure foot reflexology is that by applying mechanical stimulations in the form of momentary pressure and relaxation on specific areas on the feet, one is able to rectify the internal organs functions. With this hypothesis, a predetermined reflexology protocol was applied to treat the study group patients holistically. Reflexology therapy was applied by their own caregivers who got trained in the reflexology technique. For this purpose, an initial period of 2 ½ -3 months was devoted to train the caregivers with periodic monitoring of their performances. Reflexology was applied 3 sessions per day, each session of ½ hour duration. At the completion of training, therapy was applied 2 sessions per day for a further period of 3 months. The duration of the trial was 6 months for both the groups. All the data were recorded for both the groups at the pre- and post- therapy stages. The reflexology data for detecting the abnormal functions of the internal organs were recorded for the study group patients only.The primary outcome measure of this trial was the pain score measured by Visual Analogue Scale (VAS) in the range of 0 to 10, where 0 indicates no pain and 10 indicates excruciating pain. The secondary outcome measures were the Quality of life in neuropathy measured by neuroQOL. The objective parameters recorded are (i) blood sugar level (both fasting and pp) (ii) glycosylated HbA1c, (iii) blood pressure, (iv) frequency of urination, (v) nerve conduction velocity (NCV), (vi) vibration sensitivity and (vii) thermal sensitivity. The subjective parameters were measured using standard questionnaire and these include (i) numbness in the legs / feet, (ii) tingling sensation, (iii) burning sensation, (iv) difficulty in walking and (v) difficulty in standing. All these data were analyzed statistically using students t- test, Chisquare test / Fishers exact test with the software STATA 9.0 (college station, Texas USA).The VAS pain score was found to be 61.48% and 34% improvement for the study and control group patients respectively with a p-value of 0.001. There are 53% improvements in Quality of Life in neuropathy for the study group patients with a p-value of 0.001. There was marked improvement in all other parameters as mentioned above in the study group patients when compared with the control group ones, with statistically highly significant values (p-value < 0.001).The observations on the pre- and post- therapy data of the reflexology features viz., tenderness, hollowness formation, abnormal pigmentation, swelling, corn formation, etc on the feet (if it is not due to unfit of the shoes), led to conclude on the functional status of the internal organs. This is an important observation of this trial which may be used for diagnose the abnormal functions and hence the related ailment(s).