| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [om.wadhokar@dpu.edu.in].
- 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.
- 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. |