FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2010/091/001072 [Registered on: 05/07/2010]
Last Modified On: 15/03/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  
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 
Scientific Title of Study
Modification(s)  
Randomized clinical trial (RCT) of Reflexology therapy and usual drug treatment in the management of intractable epilepsy 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Mrs Krishna Dalal 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Biophysics
All India Institute of Medical Sciences
New Delhi
DELHI
110029
India 
Phone  01126593215  
Fax  01126588663  
Email  drkrishnadalal@gmail.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Mrs Krishna Dalal 
Designation   
Affiliation  Associate Professor  
Address  Department of Biophysics
All India Institute of Medical Sciences
New Delhi
DELHI
110029
India 
Phone  01126593215  
Fax  01126588663  
Email  drkrishnadalal@gmail.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr Manjari Tripathi 
Designation  Additional Professor 
Affiliation   
Address  Department of Neurology
All India Institute of Medical Sciences
New Delhi
DELHI
110029
India 
Phone  01126594494  
Fax  01126588663  
Email  manjari.tripathi@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Monetary support: Central Council for Research in Yoga & Naturopathy, Department of AYUSH, Ministry of Health and Family Welfare, Government of India Material support: All India Institute of Medical Sciences (AIIMS), New Delhi  
 
Primary Sponsor
Modification(s)  
Name  Central Council for Research in Yoga Naturopathy 
Address  Department of AYUSH, Ministry of Health and Family Welfare , Government of India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Nil   
 
Countries of Recruitment
Modification(s)  
  India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mrs Krishna Dalal  All India Institute of Medical Sciences  Department of Biophysics,All India Institute of Medical Sciences-110029
New Delhi
DELHI 
01126593215
01126588663
drkrishnadalal@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110 029  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Intractable epilepsy  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Anti-epileptic drugs (AEDs)  Pharmacological drugs were assigned by the concerned clinician  
Intervention  Reflexology therapy of 30 minutes duration twice a day in addition to the anti-epileptic drugs (AEDs)   
 
Inclusion Criteria
Modification(s)  
Age From  3.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  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.  
 
ExclusionCriteria 
Details  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.  
 
Method of Generating Random Sequence
Modification(s)  
Computer generated randomization 
Method of Concealment
Modification(s)  
Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking
Modification(s)  
Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
1.Response of the patients to the therapy which was measured in terms of improvement in reducing seizure frequency (R)
2.No. of times seizures could be aborted during aura
3.Quality of life in epilepsy
 
1 year 6 months 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1.Abnormal features noted on the reflex areas
2.Any other associated symptom
 
1 year 6 months 
 
Target Sample Size
Modification(s)  
Total Sample Size="98"
Sample Size from India="98" 
Phase of Trial
Modification(s)  
Phase 2 
Date of First Enrollment (India)
Modification(s)  
15/07/2005 
Date of First Enrollment (Global)  15/07/2005 
Estimated Duration of Trial
Modification(s)  
Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
K. Dalal, H. Kumar, K.G. Sharma, M. Tripathi, Elanchezhiyan D: An integrated management of intractable epilepsy through reflexology and AEDs [abstract].Epilepsia, 50(Suppl. 11):1–502, 2009. 
Brief Summary
Modification(s)  

This randomized clinical trial was conducted to observe the efficacy of reflexology therapy in addition to anti-epileptic drugs (AEDs) in treating patients suffering from intractable epilepsy. The hypotheses of hand- and foot- reflexology therapy were respectively to produce results similar to that of vagus nerve stimulations and to maintain homeostasis in the functional status among the body parts. All the subjects taken part in this clinical trial were recruited from the out patients department of Neurology, All India Institute of Medical Sciences (AIIMS). Training on reflexology therapy and monitoring the therapy compliances were performed in the department of Biophysics, AIIMS. The patients were surgically failures or not candidates for palliative epilepsy surgery or non-responders of AEDs. Intractable epilepsy patients were defined as the subjects who had been suffering for a duration of more than 2 years, having seizure frequency at least 2 seizures per month and not responding to at least two anti-epileptic drugs (AEDs) on adequate doses with good compliances. The trial could be completed in a group of 84 patients who had been randomly assigned into two groups. Both control and active group subjects continued on their respective ongoing AEDs. The active group patients received hand- and foot -reflexology therapy in addition. Amongst the types of epilepsy, the observed ones were dyscognitive seizures,  evolving to  bilateral, convulsive seizures (involving tonic, clonic, or tonic and clonic components) and others which included partial seizure, general motor seizure and Lennox Gastaut Syndrome. For the active group patients, reflexology therapy was applied following a pre-determined therapy protocol in a staged manner for an average duration of 2½ months with periodic monitoring of the therapy application compliances. Patients got the reflexology therapy applied by their caregivers at their desired places. During this training period, the patients and their caregivers were presented at the reflexology laboratory for the following purposes: (i) to get the caregivers trained on a particular step of reflexology therapy, (ii) to monitor the response of reflexology therapy, if there developed any adverse effect, and (iii) to assess the quality assurance of the compliances. Patients were asked to apply reflexology therapy on feet 2 times per day. Stimulations on the reflexology areas of the vagus nerve, which were mapped on hands, were produced by the thumb-nail of the patients/caregivers. This process was prescribed for 5 sessions per day with 15 stimulations of ~20 seconds’ duration per session.  The follow-up period of each subject started from the day of 1st therapy session administered and it was 1½ year irrespective of the group. During this follow-up period, the active group patients were asked to report at the laboratory at least once per week for the initial period of 2½ months; 2 times per months for a period of next 6 months; and thereafter once in a month. Identical procedure was followed for the control 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 months once per day with the hypothesis of avoiding regeneration of the epileptic foci. The primary outcome measures were to determine (i) the % of reduction in seizure frequency at the end of the follow-up period with respect to the baseline; and (ii) improvement in the quality of life in epilepsy. The secondary outcomes were to detect the knee/lower limb pain (measured by using visual analogue scale) and other associated symptoms by the reflexology method; and accordingly reflexology therapy was applied. Data records on seizure frequency were collected from the seizure diaries maintained by the caregivers.  Reduction in seizure frequency 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 was statistically analyzed using paired sample T-test. The median seizure frequency (number of seizures/month) in control group reduced from 18(range 2-700) to 16(range 2-700). These data for active group were 12(range 2-800) and 2(range 0-210) respectively. There was 87.5% reduction in seizure frequency in the active group (p-value < 0.001). The pre-therapy scores of the quality of life in epilepsy for control and active groups were 41.05±7 and 43.6±8 respectively. The respective post-therapy data were 49.07±6 and 65.4 ± 9. The comparative data were statistically significant with p-value of 0.002. In the group of evolving to bilateral, convulsive seizures, the excellent response (75%≤Response≤100%) was among 76.9% patients. The excellent responses were found to be 54.5% and 50% among the dyscognitive seizures and other types of seizures respectively. Using reflexology techniques, it was possible to detect the internal organ dysfunctions by observing certain external features on the feet and hands. The abnormalities 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 was observed that 86% of the active group patients suffered from lower limb pain with a p-value<0.001. Post-therapy data revealed that 84% patients responded with 81% reduction in pain severity (p-value<0.001). Other associated symptoms viz., 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. These observations were similar to the findings of directly implanted Vagus Nerve Stimulations as reported by vagus nerve stimulation study group. The observations of this clinical trial brought out with the possibility that acupressure hand- and foot- reflexology therapy together with AEDs may be useful for treating patients with intractable epilepsy especially evolving to bilateral, convulsive seizures and dyscognitive seizures. However, a multi-centre study is required to validate all the observations of this phase-II clinical trial.

 
Close