| CTRI Number |
CTRI/2025/05/086657 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Reulsive Compress on Piriformis Syndrome |
|
Scientific Title of Study
|
Effect of Reulsive Compress on Piriformis Syndrome |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay Kumar |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
R Block Sant Ravidas Bhawan Flat no 1 Swami Vivekanand Subharti University
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8979494643 |
| Fax |
250005 |
| Email |
abhaysinghnaturecure@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
R Block Sant Ravidas Bhawan Flat no 1 Swami Vivekanand Subharti University
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8979494643 |
| Fax |
250005 |
| Email |
abhaysinghnaturecure@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
R Block Sant Ravidas Bhawan Flat no 1 Swami Vivekanand Subharti University
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8979494643 |
| Fax |
250005 |
| Email |
abhaysinghnaturecure@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abhay Kumar |
| Address |
R Block Sant Ravidas Bhawan Flat no 1 Swami Vivekanand Subharti University |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Swami Vivekanand Subharti University |
Subhartipuram, Delhi-Haridwar Meerut Bypass road, NH-58, Meerut - 250005 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhay Kumar |
Maharishi Aurobindo Subharti and College and Hospital of Naturopathy and Yogic Sciences |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences, Swami Vivekanand Subharti University
Meerut
UTTAR PRADESH |
8979494643
250005
abhaysinghnaturecure@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical), Swami Vivekanand Subharti Univesity |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Revulsive Compress |
Revulsive compress is given on the lower back for 20 minutes in which the hot application is made for several minutes and cold application for a few seconds. The hot fomentation bag is applied over the lower back for 4 minutes followed by a cold application (ice bag) which is applied for 1 minute. This is repeated for 4 times. |
| Intervention |
Revulsive Compress |
Revulsive compress is given on the lower back for 20 minutes in which the hot application is made for several minutes and cold application for a few seconds. The hot fomentation bag is applied over the lower back for 4 minutes followed by a cold application (ice bag) which is applied for 1 minute. This is repeated for 4 times. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both Males and females
aged group between 30–70 years
Positive FAIR (flexion, adduction and internal rotation) test
Pain for more than one month |
|
| ExclusionCriteria |
| Details |
Individuals with leg pain that was not related to the piriformis, disc herniation, sacroiliac joint dysfunction, degenerative joint disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Electromyomanogram (EMG) |
Electromyomanogram (EMG) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale |
Visual analogue scale |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Intervention: Revulsive compress: Temperature- Hot 98-104 0F (36-400C) and cold 55-650F (12-180C) Duration- 20 minutes(32) Apparatus –Hot fomentation bag and ice bag. Procedure – Revulsive compress is given on the lower back for 20 minutes in which the hot application is made for several minutes and cold application for a few seconds. The hot fomentation bag is applied over the lower back for 4 minutes followed by a cold application (ice bag) which is applied for 1 minute. This is repeated for 4 times. |