| 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)
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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 |
| Trial Acronym |
|
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)
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| 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)
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| 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
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|
Countries of Recruitment
Modification(s)
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India |
Sites of Study
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|
| 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 |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
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| 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)
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| 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)
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Computer generated randomization |
Method of Concealment
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|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
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| 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
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| 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"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
15/07/2005 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/07/2005 |
| Date of Study Completion (Global) |
Date Missing |
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. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
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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.
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