| CTRI Number |
CTRI/2010/091/001091 [Registered on: 22/07/2010] |
| Last Modified On: |
12/03/2013 |
| 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
|
A clinical trial to determine the effect of Reflexology therapy in addition to the pharmacological drugs for managing patients suffering from Diabetic Neuropathy |
|
Scientific Title of Study
|
Randomized Clinical Trial (RCT) on the effect of reflexology in the management of patients suffering from diabetic neuropathy: Case studies |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| I 483 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Dalal |
| Designation |
|
| Affiliation |
|
| Address |
Dept 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
|
| Name |
Dr Krishna Dalal |
| Designation |
|
| Affiliation |
Head & Associate Professor |
| Address |
Dept 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
|
| Name |
Dr (Mrs) Manjari Tripathi |
| Designation |
|
| 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 |
|
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Source of Monetary or Material Support
|
| Monetary support: Indian Council of Medical Research (ICMR), New Delhi. Material support: All India Institute of Medical Sciences (AIIMS), New Delhi |
|
Primary Sponsor
Modification(s)
|
| Name |
Indian Council of Medical Research ICMR New Delhi |
| Address |
Indian Council of Medical Research
P.O. Box No. 4911
Ansari Nagar
New Delhi - 110029
India |
| Type of Sponsor |
Government funding agency |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishna Dalal |
Department of Biophysics, 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
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, All India Institute of Medical Sciences New Delhi 110 029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Diabetic Neuropathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pharmacological drugs |
Pharmacological drugs were assigned by the concerned clinician |
| Intervention |
Reflexology therapy which will be of 30 minutes duration twice a day, during which the specific reflex areas on feet are stimulated along with the pharmacological drugs. |
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Day(s) |
| Gender |
Both |
| Details |
1. Age group: any age
2. Both of sex
3. Patients who were residents of Delhi or have arrangement for stay over Delhi for a minimum duration 1 month. And during the follow-up period, the proper correspondence should be available to the laboratory for getting the information about their health status.
This is required for monitoring their health in response to reflexology.
4. Patients who have signed in informed consent proforma
5. Patients with Blood sugar level: greater than or equal to 120mg/decilitre(Fasting) and greater than or equal to 200mg/deciliter (post prandial) for more than 1 occasion
6. Patients with documented peripheral diabetic neuropathy. |
|
| ExclusionCriteria |
| Details |
1. Patients non-resident of Delhi or not having any
arrangement to stay in Delhi during the training period
which was 2½ months -3 months
2. Patients with end organ damage (viz., gangrene, toes
or foot amputation) due to diabetes/any cause
3. Patients not willing to sign informed consent from
4. Patients suffering from over-neuropathy
5. Patients with other chronic disorders like malignancy,
T.B., asthma or any communicable disease.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Neuropathy pain score measured by Visual Analogue Scale (VAS) in the range of 0-10, where 0 indicates no pain while 10 indicates excruciating pain |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life in neuropathy as measured by neuroQOL, responses on the reflex areas, objective and subjective parameters.
Abnormal features recorded on the reflex areas:
(i) Tenderness
(ii) Hollowness formation
(iii) Abnormal pigmentation
(iv) Swelling
(v) Corn formation
Objective parameters:
(i) Blood sugar level F & PP
(ii) Glycosylated HbA1c
(iii) Blood pressure
(iv) Frequency of urination
(v) Nerve conduction velocity
(vi) Vibration sensitivity
(vii) Thermal sensitivity
Subjective parameters (standard questionnaire):
(i) Numbness in the legs/ feet
(ii) Tingling sensation
(iii) Difficulty in walking
(iv) Difficulty in standing
(v) Burning sensation
|
6 months for all the secondary outcome measures |
|
Target Sample Size
Modification(s)
|
Total Sample Size="71"
Sample Size from India="71"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/12/2006 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
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).
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