A randomized clinical trial for determining the efficacy of acupressure hand- and foot- reflexology in addition to the anti-epileptic drugs (AEDs) compared with AEDs alone in the management of patients suffering from intractable epilepsy

Phase 2

Completed

Conditions: Intractable epilepsy

Registration Number: CTRI/2010/091/001072

Lead Sponsor: Central Council for Research in Yoga Naturopathy

Brief Summary: This randomizedclinical trial was conducted to observe the efficacy of reflexology therapy inaddition to anti-epileptic drugs (AEDs) in treating patients suffering fromintractable epilepsy. The hypotheses of hand- and foot- reflexology therapywere respectively to produce results similar to that of vagus nervestimulations and to maintain homeostasis in the functional status among thebody parts. All the subjects taken part in this clinical trial were recruitedfrom the out patients department of Neurology, All India Institute of MedicalSciences (AIIMS). Training on reflexology therapy and monitoring the therapycompliances were performed in the department of Biophysics, AIIMS. The patientswere surgically failures or not candidates for palliative epilepsy surgery ornon-responders of AEDs. Intractable epilepsy patients were defined as thesubjects who had been suffering for a duration of more than 2 years, havingseizure frequency at least 2 seizures per month and not responding to at leasttwo anti-epileptic drugs (AEDs) on adequate doses with good compliances. Thetrial could be completed in a group of 84 patients who had been randomlyassigned into two groups. Both control and active group subjects continued ontheir respective ongoing AEDs. The active group patients received hand- andfoot -reflexology therapy in addition. Amongst the types of epilepsy, theobserved ones were dyscognitive seizures, evolving to bilateral, convulsive seizures (involving tonic, clonic, or tonic andclonic components) and others which included partial seizure, general motorseizure and Lennox Gastaut Syndrome. For the active group patients, reflexologytherapy was applied following a pre-determined therapy protocol in a stagedmanner for an average duration of 2Â½ months with periodic monitoring of thetherapy application compliances. Patients got the reflexology therapy appliedby their caregivers at their desired places. During this training period, thepatients and their caregivers were presented at the reflexology laboratory forthe following purposes: (i) to get the caregivers trained on a particular stepof reflexology therapy, (ii) to monitor the response of reflexology therapy, ifthere developed any adverse effect, and (iii) to assess the quality assuranceof the compliances. Patients were asked to apply reflexology therapy on feet 2times per day. Stimulations on the reflexology areas of the vagus nerve, whichwere mapped on hands, were produced by the thumb-nail of thepatients/caregivers. This process was prescribed for 5 sessions per day with 15stimulations of ~20 secondsâ€™ duration per session. The follow-up period of each subject startedfrom the day of 1st therapy session administered and it was 1Â½ yearirrespective of the group. During this follow-up period, the active grouppatients were asked to report at the laboratory at least once per week for theinitial period of 2Â½ months; 2 times per months for a period of next 6 months;and thereafter once in a month. Identical procedure was followed for thecontrol group patients also. Though the follow-up period was 1 year 6 months,reflexology therapy was advised to be continued up to the next 3years 6 monthsonce per day with the hypothesis of avoiding regeneration of the epilepticfoci. The primary outcome measures were to determine (i) the % of reduction inseizure frequency at the end of the follow-up period with respect to thebaseline; and (ii) improvement in the quality of life in epilepsy. Thesecondary outcomes were to detect the knee/lower limb pain (measured by usingvisual analogue scale) and other associated symptoms by the reflexology method;and accordingly reflexology therapy was applied. Data records on seizurefrequency were collected from the seizure diaries maintained by thecaregivers. Reduction in seizurefrequency in both groups was compared using Wilcoxon non-parametric test.Within the group, the parameters were compared by two sided Wilcoxon Sign test.The quality of life was assessed by using QOLIE-31 instrument and the data wasstatistically analyzed using paired sample T-test. The median seizure frequency(number of seizures/month) in control group reduced from 18(range 2-700) to16(range 2-700). These data for active group were 12(range 2-800) and 2(range0-210) respectively. There was 87.5% reduction in seizure frequency in the activegroup (p-value < 0.001). The pre-therapy scores of the quality of life inepilepsy for control and active groups were 41.05Â±7 and 43.6Â±8 respectively. Therespective post-therapy data were 49.07Â±6 and 65.4 Â± 9. The comparative data werestatistically significant with p-value of 0.002. In the group of evolving tobilateral, convulsive seizures, the excellent response (75%â‰¤Responseâ‰¤100%) wasamong 76.9% patients. The excellent responses were found to be 54.5% and 50%among the dyscognitive seizures and other types of seizures respectively. Usingreflexology techniques, it was possible to detect the internal organdysfunctions by observing certain external features on the feet and hands. Theabnormalities observed on the reflexology areas were tenderness, pigmentation,swelling, hollowness, scaly skin, reoccurrence of corn or callus formation etc.(if it was not due to the misfit of foot wares). By this method, it wasobserved that 86% of the active group patients suffered from lower limb painwith a p-value<0.001. Post-therapy data revealed that 84% patients respondedwith 81% reduction in pain severity (p-value<0.001). Other associated symptomsviz., urinary disorders and blood pressure were also improved with statistical significance(p-value<0.05). It was also revealed that there were changes in (i)hoarseness (1 patient), (ii) vomiting (1 patient) and (iii) voice change (2 patients)that developed during the trial period in 4 patients of the active group. Theseobservations were similar to the findings of directly implanted Vagus NerveStimulations as reported by vagus nerve stimulation study group. Theobservations of this clinical trial brought out with the possibility thatacupressure hand- and foot- reflexology therapy together with AEDs may beuseful for treating patients with intractable epilepsy especially evolving tobilateral, convulsive seizures and dyscognitive seizures. However, amulti-centre study is required to validate all the observations of thisphase-II clinical trial.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 98

Inclusion Criteria

Patients of the age group of 3 years to 50 years and both genders had been included if they were the residents of Delhi or had some arrangements to stay in Delhi (the centre of study), for a period of minimum three months, and submitted of their own the filled-in consent proforma.
They had been suffering from confirmed epilepsy with at least a frequency of 2 seizures per month, had failed 2 or more drugs in various rational combinations over a period of 2 or more years.
They were surgical failures or were not the candidates for surgery.
They were likely to stay on the stable and adequate doses of AEDs for a period of 3 months prior to the trial.

Exclusion Criteria

Any patient suffering from either or more of the following diseases has been excluded from this study: malignancy of any kind, brain tumor, encephalitis, meningitis, tuberculosis, HIV-infection, and any kind of organ resection due to any reason.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Response of the patients to the therapy which was measured in terms of improvement in reducing seizure frequency (R)	1 year 6 months
2.No. of times seizures could be aborted during aura	1 year 6 months
3.Quality of life in epilepsy	1 year 6 months

Secondary Outcome Measures

Name	Time	Method
1.Abnormal features noted on the reflex areas	2.Any other associated symptom

Trial Locations

Locations (1): All India Institute of Medical Sciences
🇮🇳
Delhi, DELHI, India
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr Mrs Krishna Dalal
Principal investigator
01126593215
drkrishnadalal@gmail.com