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CTRI Number  CTRI/2025/10/095581 [Registered on: 03/10/2025] Trial Registered Prospectively
Last Modified On: 01/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two manual therapy technique in hip pain participants for improvement in pain, range of motion and function 
Scientific Title of Study   Comparative effectiveness of muscle energy technique and positional release technique on hip pain, range of motion and function in piriformis syndrome 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
N/A  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mehar Negi 
Designation  MPT(Musculoskeletal) student 
Affiliation  ISIC -IRS 
Address  Room no. 3, 2nd floor, (Musculoskeletal department) Indian Spinal Injuries Center Institute of Rehabilitation Sciences Sector C Vasant Kunj New Delhi

South West
DELHI
110070
India 
Phone  9643191895  
Fax    
Email  meharnegi1612@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Megha Nijhawan 
Designation  Associate Professor 
Affiliation  ISIC-IRS 
Address  2nd floor, Musculoskeletal lab, Indian Spinal Injuries Center Institute Of Rehabilitation Sciences Sector C Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  8802021752  
Fax    
Email  physiomegha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mehar Negi 
Designation  MPT (Musculoskeletal) student 
Affiliation  ISIC-IRS 
Address  Room No. 3, 2nd Floor (Musculoskeletal department) Indian Spinal Injuries Center Institute of Rehabilitation Sciences Sector C Vasant Kunj New Delhi

South West
DELHI
110070
India 
Phone  09643191895  
Fax    
Email  meharnegi1612@gmail.com  
 
Source of Monetary or Material Support  
Indian Spinal Injuries Center Institute of Rehabilitation Sciences, Sector C, Vasant Kunj, South Delhi-110070,India  
 
Primary Sponsor  
Name  NA 
Address  N/A 
Type of Sponsor  Other [N/A] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mehar Negi PT  Indian Spinal Injuries Center Institute of Rehabilitation Sciences  Room No. 3, 2nd Floor (Musculoskeletal department) Indian Spinal Injuries Center Institute of Rehabilitation Sciences Sector C New Delhi
South West
DELHI 
09643191895

meharnegi1612@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Muscle energy technique  This is group A will receive muscle energy technique for 5 to 7 seconds for 3 repetitions 
Comparator Agent  Positional release technique  Group B will receive positional release technique hold it for 90 seconds for 3 repetitions 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Unilateral buttock pain
Pain greater or equal to 4cm or above on VAS and persists for at least 1 month
Aggravation of pain by sitting
External tenderness over the greater sciatic notch
Pain with maneuvers that increase tension in the piriformis muscle. FAIR Flexion, Adduction and Internal rotation HCLK Heel contralateral knee participants diagnosed with piriformis syndrome
 
 
ExclusionCriteria 
Details  Diagnosed with spinal causes of sciatic pain: Lumbar disc herniation, spinal stenosis, spondylolisthesis
History of spine or lower limb surgery
Diagnosed with neurological disorders- peripheral neuropathy
Axial Spinal palpation painful L2 to S1
SLR Positive
Pregnancy
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
VAS for hip pain  0 week (Baseline), 1 week and 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Universal goniometer for hip range of motion and LEFS for function
 
Baseline, 1 week and 2 weeks after intervention 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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)   15/10/2025 
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="7"
Days="0" 
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  
Introduction
Piriformis syndrome is a painful musculoskeletal condition characterized by buttock or hip pain, often leading to chronic discomfort, restricted hip mobility, and functional limitations. 
 It can significantly affect daily activities and impose a socioeconomic burden. Manual therapy techniques such as Muscle Energy Technique (MET) and Positional Release Technique (PRT) are frequently used in its management. MET aims to improve muscle length and joint mobility through controlled contractions, whereas PRT reduces muscle spasm by positioning the muscle in a shortened, pain-free state. 
 Review of Literature-Previous studies have demonstrated positive effects of both techniques on pain, hip range of motion (ROM), and function in piriformis syndrome; however, there is no consensus on which is more effective. Limited comparative research exists, creating a gap in evidence-based practice.
 This study aims to compare the effectiveness of MET and PRT on pain, hip internal rotation ROM, and functional ability in individuals with piriformis syndrome.
Objectives and Hypothesis
Primary Objectives:
To compare the effectiveness of Muscle Energy Technique (MET) and Positional Release Technique (PRT) on pain, hip internal rotation and function in piriformis syndrome.

Null hypothesis: There is no significant difference in the effectiveness of MET and PRT on pain (VAS), improving hip internal rotation (Universal Goniometer) and in enhancing function (LEFS) in individuals with piriformis syndrome.
Alternate hypothesis: There is significant difference in the effectiveness of MET and PRT on pain (VAS), improving hip internal rotation (Universal Goniometer) and function in piriformis syndrome.

Materials and Methods
a. Study Design: Randomized Controlled Trial
b. Sample size and method
Sample Size: 22 participants (11 in each group)
 Method of Calculation: Based on previous study (Velappanchavadi, 2019) taking VAS (Visual Analog Scale) as the primary outcome, with:
Effect size = 1.11
Alpha = 0.05
Power = 0.80

c. Enrolment period: approximately 5–6 months after RRC and IEC approval
d. Total Study duration: approximately 6 months 
e. Inclusion and exclusion criteria:  Participants aged 18–50 years diagnosed with piriformis syndrome with unilateral buttock pain more than or equal to 4 cm on VAS for at least 1 month will be included. Exclusion criteria include spinal pathologies, prior spine/lower limb surgery, neurological disorders, pregnancy, and positive SLR.
f. Study Procedure: After RRC and IEC clearance, participants fulfilling inclusion criteria were enrolled after informed consent. They were randomly allocated into two groups using random allocation software. Baseline assessment of pain (VAS), hip internal rotation (Universal Goniometer), and function (LEFS) was done.
Group A: MET and  Conventional Physiotherapy
Group B: PRT and  Conventional Physiotherapy
Both groups received 6 sessions per week for 2 weeks. Post-intervention assessments were taken at the end of week 1 and week 2 using the same outcome measures. Data collection lasted 5–6 months and analysis will be  performed using SPSS v21.
g. Assessment tools:
 Pain is assesses by Visual Analog Scale (VAS)
 Hip Internal Rotation Range of Motion assess by  Universal Goniometer
 Function assesses by  Lower Extremity Functional Scale (LEFS)

      Statistical Analysis Plan (SAP)
Data will be analyzed using SPSS v21.0 with a significance level of  0.05 and power of 0.80 . Descriptive statistics will summarize data as mean and standard deviation or median (IQR) for continuous variables and frequencies for categorical variables. Normality will be tested using the Shapiro–Wilk test. For normal data, between-group changes will be analyzed using Mixed-Model ANOVA and within-group changes using Repeated Measures ANOVA; for non-normal data, the Friedman and Wilcoxon signed-rank tests will be used. Effect sizes, p-values, and 95 percentage confidence intervals will be reported, with missing data handled appropriately.

 
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