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CTRI Number  CTRI/2024/11/076698 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 09/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Active Release Therapy and Muscle Energy Technique for Reducing Pain, Disability, and Depression in Individuals with Chronic Low Back Pain 
Scientific Title of Study   Effectiveness of Active Release Therapy Versus Muscle Energy Technique on Pain, Disability, and Depression in Chronic Non-Specific Low Back Pain: 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  Dr Om Wadhokar 
Designation  Assistant Professor 
Affiliation  Dr. DY Patil College of Physiotherapy 
Address  Dr. DY Patil College of Physiotherapy, MSK department, Pimpri, Pune
Dr. DY Patil College of Physiotherapy, out patient department, Pimpri, Pune
Pune
MAHARASHTRA
411018
India 
Phone  9158492096  
Fax    
Email  om.wadhokar@dpu.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Om Wadhokar 
Designation  Assistant Professor 
Affiliation  Dr. DY Patil College of Physiotherapy 
Address  Dr. DY Patil College of Physiotherapy, MSK department, Pimpri, Pune
Dr. DY Patil College of Physiotherapy, out patient department, Pimpri, Pune
Pune
MAHARASHTRA
411018
India 
Phone  9158492096  
Fax    
Email  om.wadhokar@dpu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Om Wadhokar 
Designation  Assistant Professor 
Affiliation  Dr. DY Patil College of Physiotherapy 
Address  Dr. DY Patil College of Physiotherapy, MSK department, Pimpri, Pune
Dr. DY Patil College of Physiotherapy, Out patient department, Pimpri, Pune
Pune
MAHARASHTRA
411018
India 
Phone  9158492096  
Fax    
Email  om.wadhokar@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr. DY Patil College of Physiotherapy, Dr. DY Patil Vidyapeeth, Pimpri, Pune, India, 411028 
 
Primary Sponsor  
Name  Dr DY Patil College of Physiotherapy Pune 
Address  Dr. DY Patil College of Physiotherapy, Dr. DY Patil Vidyapeeth, Pimpri, Pune, India, 411018 
Type of Sponsor  Private medical college 
 
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 
Navneet Mehta  Dr DY Patil Medical college, Hospital and research center  Physiotherapy department, OPD out patient department
Pune
MAHARASHTRA 
8805217289

navneetmehta2182@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical comittee of Dr. DY Patil College of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M999||Biomechanical lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Active Release Technique  Active Release Therapy (ART) is a mobilization of soft tissues. This non-intrusive treatment method of soft tissue finds and eliminates adhesions and tissue scarring that are the source of pain, bodily dysfunctions, reducing of sensations, fatigue and stiffness. duration is 6 days for 2 weeks 
Comparator Agent  Muscle Energy Technique  Muscle Energy Techniques (MET) are a set of soft tissue osteopathic manipulations that utilize accurately directed, patient initiated and controlled, isometric contractions which are intended to recover musculoskeletal function and reduce pain. duration is 6 days for 2 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1)Age: 18- 50 year young and middle aged adults.
2)Experiencing non-specific low back pain lasting for more than 3 months.
3)Mild to moderate functional disability.
4)Mild to moderate Depression.
5)Those who are willing to participate and ready to fill consent form.
 
 
ExclusionCriteria 
Details  1)History of recent trauma or surgery to the lower back, pelvis, hip.
2)Undergoing any other physiotherapy treatment.
3)Neurological disorders affecting lower limb or back.
4)Not willing to participate.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pressure Algometer  Day 0, After 1 week, After 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Oswestry Disability Index  Day 0, After 1 week, After 2 weeks 
Beck Depression Inventory  Day 0, After 1 week, After 2 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   19/11/2024 
Date of Study Completion (India) 11/06/2025 
Date of First Enrollment (Global)  19/11/2024 
Date of Study Completion (Global) 11/06/2025 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [om.wadhokar@dpu.edu.in].

  6. For how long will this data be available start date provided 08-11-2024 and end date provided 08-11-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Introduction: Low back pain (LBP) is labelled as pain, muscle stiffness or muscle tautness that is regionalized beneath the costal boundary and over the inferior gluteal folds. Chronic Low back pain (CLBP) is usually classified as when it exceeds over more than 12 weeks or 3 months. Non-Specific LBP refers to symptoms of unknown origin, without a clear specific cause. Not much is known about comparing the effects of Active Release Technique (ART) and Muscle Energy Technique (MET) with conventional treatment that have shown positive outcomes in CLBP.

Need for the study: There is no clear evidence comparing the effectiveness of ART and MET for non-specific CLBP. This study aims to address this issue by comparing the effects of ART versus MET, both combined with Conventional treatment, to assess which approach more effectively reduces Pain, Disability and reduces Depression in non-specific CLBP.

Aim of the study: To compare the Effectiveness of ART versus MET on Pain, Disability and Depression in Non-Specific CLBP.

Materials and Methods: This research protocol is planned to conduct a comparative study in Pune, India. The duration of the study will be 6 months. A total of 30 young and middle aged adults with non-specific CLBP, aged between 18-50 will be allotted into 2 groups ART (N=15) and MET (N=15). For a period of 2 weeks (3 sessions per week). The Algometer will assess pain. The Oswestry disability index will assess disability. The Beck Depression inventory will assess the level of depression. These measures will be assessed prior to the intervention, after 3 sessions and post intervention.

Results: This study will provide a definitive comparison of the effectiveness of ART versus MET along with conventional treatment in non-specific CLBP. Both groups showed significant improvements in pain, disability and depression. However the ART group experienced a faster reduction in pain and greater improvements in function and depression, while the MET group provided comparatively less sustained improvements.

Conclusion: Both ART and MET are effective for managing CLBP, while ART offering faster pain relief, functional recovery and benefits for depression. The choice of therapy should be tailored to patient specific needs and treatment goals.

 
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