| CTRI Number |
CTRI/2025/07/090173 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Comparative Study (RCT)] |
| Study Design |
Other |
|
Public Title of Study
|
This study aims to find out which technique (PRT or MRT) is more effective in reducing pain, improving mobility, and enhancing daily functioning for people with Piriformis Syndrome. |
|
Scientific Title of Study
|
Effects of Positional Release Technique Versus Myofascial Release Technique on Pain, Range of Motion and Functional Impact on Lower Extremity among Patients with Piriformis Syndrome: A Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lucky Pandey |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Plot No.2 Sector 17A Yamuna Expressway Greater Noida Gautam Buddh Nagar Uttar Pradesh India
Department of Physiotherapy School of Allied Health Science Galgotias University Plot No.2 Sector 17A Yamuna Expressway Opp. Buddha International Circuit Greater Noida Gautam Buddh Nagar
Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9311258326 |
| Fax |
|
| Email |
lucky11.841428@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lucky Pandey |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
E003 Block E Department of Physiotherapy School of Allied Health Science Galgotias University Plot No.2 Sector 17A Yamuna Expressway Opp. Buddha International Circuit Greater Noida Gautam Buddh Nagar Uttar Pradesh 203201
Plot No.2 Sector 17A Yamuna Expressway Opp. Buddha International Circuit Greater Noida Gautam Buddh Nagar Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9311258326 |
| Fax |
|
| Email |
lucky11.841428@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lucky Pandey |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
E003 Block E Department of Physiotherapy School of Allied Health Science Galgotias University Plot No.2 Sector 17A Yamuna Expressway Opp. Buddha International Circuit Greater Noida Gautam Buddh Nagar Uttar Pradesh 203201
Plot No.2 Sector 17A, Yamuna Expressway Opp. Buddha International Circuit Greater Noida, Gautam Buddh Nagar Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9311258326 |
| Fax |
|
| Email |
lucky11.841428@gmail.com |
|
|
Source of Monetary or Material Support
|
| Various Hospital of Noida and Delhi India 203201 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
nil |
| Type of Sponsor |
Other [] |
|
|
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 Pragnya Jyoti Dash |
Galgotias University |
Plot No 2 Sector 17-A Yamuna Expressway Greater Noida Gautam Buddh Nagar Uttar Pradesh India 201306
Gautam Buddha Nagar
UTTAR PRADESH |
9475427313
pragnya.dash@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| DEPARTMENTAL RESEARCH COMMITTEE |
Approved |
| DEPARTMENTAL RESEARCH COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manual therapy |
Comparison of Effects of two manual techniques :Positional Release Technique vs Myofascial Release Technique among Piriformis Syndrome |
| Intervention |
Manual Therapy: Positional Release Technique And Myofascial Release technique |
In this study, the comparators are pain levels, range of motion (ROM) in the affected limb, and functional impact (assessed by a functional scale LEFS). These are the variables used to determine which technique, PRT or MFR, is more effective in treating piriformis syndrome for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Male and female with piriformis syndrome with chronic low back pain
2 Piriformis muscle tightness
3 Age 20-50 years
4 Positive test for FAIR test |
|
| ExclusionCriteria |
| Details |
1.Age below 20 years and above 50 years
2.H/O Fracture of Pelvis, Femur and Sacrum, any previous trauma
3.Subject with skin infection, any Cardiopulmonary condition, tumors, spondylitis, and disc herniation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post treatment Outcome measure will be taken using Goniometer, NPRS, and LEFS and compare both pre- treatment outcomes measure and post-treatment outcomes measure. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post treatment Outcome measure will be taken using Goniometer, NPRS, and LEFS and compare both pre- treatment outcomes measure and post-treatment outcomes measure. |
4 weeks |
| Post treatment Outcome measure will be taken using Goniometer NPRS & LEFS & compare both pre- treatment outcomes measure & post treatment outcomes measure |
4 weeks |
|
|
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)
|
14/07/2025 |
| 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="0"
Months="0"
Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study compares Positional Release Technique (PRT) and Myofascial Release Technique (MRT) for treating Piriformis Syndrome. Both techniques likely reduce pain and improve range of motion and function. One technique might be slightly more effective than the other. |