| CTRI Number |
CTRI/2024/04/065496 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the Effectiveness of Muscle Energy Technique and Positional Release Technique in subjects with piriformis syndrome |
|
Scientific Title of Study
|
Effectiveness of Muscle Energy Technique Vs Positional Release Technique in the management of 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 |
Keerthana T |
| Designation |
MPT Orthopaedic Student |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences
Room No 4017 Division of Orthopaedics Department of Physiotherapy #395
Sarojini naidu road Sidhapudur Coimbatore
Tamil Nadu
641044
India
Coimbatore
TAMIL NADU
641044
India |
| Phone |
8870396093 |
| Fax |
|
| Email |
keerthithangavel09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Saravanan K |
| Designation |
Professor |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences
Room No 4017 Division of Orthopaedics Department of Physiotherapy #395
Sarojini naidu road Sidhapudur Coimbatore
Tamil Nadu
641044
India
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9842124007 |
| Fax |
|
| Email |
Saro1978pt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Saravanan K |
| Designation |
Professor |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences
Room No 4017 Division of Orthopaedics Department of Physiotherapy #395
Sarojini naidu road Sidhapudur Coimbatore
Tamil Nadu
641044
India
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9842124007 |
| Fax |
|
| Email |
Saro1978pt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramakrishna Institute of Paramedical Sciences
Room No 4017 Division of Orthopaedics Department of Physiotherapy #395
Sarojini naidu road Sidhapudur Coimbatore
Tamil Nadu
641044
India |
|
|
Primary Sponsor
|
| Name |
Keerthana T |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences
Room No 4017 Division of Orthopaedics Department of Physiotherapy #395
Sarojini naidu road Sidhapudur Coimbatore
Tamil Nadu
641044
India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Keerthana T |
Sri Ramakrishna Multi Speciality Hospital |
Sri Ramakrishna Institute of Paramedical Sciences
Room No 4017 Division of Orthopaedics Department of Physiotherapy #395
Sarojini naidu road Sidhapudur Coimbatore
Tamil Nadu
641044
India
Coimbatore
TAMIL NADU |
8870396093
keerthithangavel09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMAKRISHNA HOSPITAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Piriformis Syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Muscle Energy Technique
Positional Release Technique |
total duration of 30 minutes duration 3 sessions per week for 2 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
both gender between 30 to 40 years
BMI:25 to 29.9 Kg/m
Symptoms lasts between 3 to 6 month
Pain: mild to moderate
positive FAIR TEST along with following symptoms
Unilateral buttock pain and radiculopathy
Gluteal pain aggravated when sitting
External tenderness near the greater sciatic notch
limited medial rotation of hip |
|
| ExclusionCriteria |
| Details |
Non cooperative patients
Pregnancy
Malignancy
Neurological conditions
Previous history of trauma and surgery to the hip and spine
Hip joint pathology
Systemic inflammatory condition
Congenital or acquired abnormality in spinal column.
Pathology at disc or facet joint
Degenerative conditions
Infectious diseases |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Range of motion
Functional ability |
At baseline and after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Effectiveness of Muscle Energy Technique Vs Positional Release Technique in the management of Piriformis Syndrome ABSTRACT The term Piriformis Syndrome defined as an entrapment neuropathy involving compression or irritation of the sciatic nerve due to piriformis muscle spasm or other inflammatory process of the muscle . The prevalence of Piriformis syndrome ranged from 12.2% to 27%. The muscle energy technique and the positional release technique are effective in the management of piriformis syndrome. AIM Aim of this study is to compare the effect of muscle energy technique vs positional release technique in the management of piriformis syndrome. OBJECTIVE To evaluate the effect of muscle energy technique in the management of piriformis syndrome. To evaluate the effect of positional release technique in the management of piriformis syndrome To compare the effectiveness of muscle energy technique and positional release technique in the management of piriformis syndrome METHODOLOGY ï‚·GROUP A : Receive post isometric relaxation of MET for 10 mins ( 3 repetition) ï‚· GROUP B: Receive positional release technique for 10 mins (3 repetition) 3 sessions/week for 2 week, Total duration of 30 minutes for each group RESULTS statistical analysis will be done after data collection and conclusion will be drawn KEYWORDS Piriformis Syndrome , muscle energy Technique , Positional Release Technique
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