| CTRI Number |
CTRI/2025/12/099845 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To compare the effect of three common therapies massage tools , massage gun and foam roller on flexibility and daily function in patients with chronic low back pain |
|
Scientific Title of Study
|
To assess long term effectiveness of Instrument assisted soft tissue mobilization, Physio gun and Foam roller on Quadratus lumborum muscle flexibility, lumbar spine range of motion and functional status of subjects with chronic low back pain - A comparative interventional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NILL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kei Rashid Mwakaleke |
| Designation |
PG Scholar |
| Affiliation |
Marwadi university |
| Address |
Marwadi university
Morbi Road Gavridad 360003
Rajkot Gujarat
Faculty of Healthy science
Department of Physiotherapy
Room number MB557
INDIA
Rajkot
GUJARAT
360003
India |
| Phone |
7400447321 |
| Fax |
|
| Email |
keirashidmwakaleke.133874@marwadiuniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ashika Tanna PT |
| Designation |
Thesis Guide |
| Affiliation |
Marwadi university |
| Address |
Marwadi university
Morbi Road Gavridad 360003
Rajkot Gujarat
Faculty of Healthy science
Department of Physiotherapy
Room number MB555
INDIA
Rajkot
GUJARAT
360003
India |
| Phone |
9913694912 |
| Fax |
|
| Email |
ashika.tanna@marwadieducation.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
kei Rashid Mwakaleke |
| Designation |
PG Scholar |
| Affiliation |
Marwadi university |
| Address |
Marwadi university
Morbi Road Gavridad 360003
Rajkot Gujarat
Faculty of Healthy science
Department of Physiotherapy
Room number MB557
INDIA
Rajkot
GUJARAT
360003
India |
| Phone |
7400447321 |
| Fax |
|
| Email |
keirashidmwakaleke.133874@marwadiuniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Marwadi university
Morbi Road Gavridad 360003
Rajkot Gujarat
Faculty of Healthy science
Department of Physiotherapy
INDIA |
|
|
Primary Sponsor
|
| Name |
Kei Rashid Mwakaleke |
| Address |
Marwadi university
Morbi Road Gavridad 360003
Rajkot Gujarat
Faculty of Healthy science
Department of Physiotherapy
Room number MB557
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 |
| Dr Kei Rashid |
Marwadi Physiotherapy Center |
Marwadi university
Morbi Road Gavridad 360003
Rajkot Gujarat
Faculty of Healthy science
Department of Physiotherapy
Room number MB557
INDIA
Rajkot
GUJARAT |
07400447321
keirashidmwakaleke.133874@marwadiuniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Marwadi University ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION |
1.By using edge tool instrument IASTM that will be kept at 45° with the skin and slow strokes along the muscle fibers from origin to insertion by using sweeping strokes followed by fanning technique will be provided for 15 minutes |
| Intervention |
FOAM ROLLER |
A firm foam, 45x12cm cylindrical roller will be used, and a slow rolling technique with moderate intensity will be applied to the Quadratus lumborum for 30 seconds at a time. Each set will consist of 10 rolls performed in a cephalocaudal direction, with ten sets in total A break of 10 s will be provided after the completion of each set |
| Comparator Agent |
NIL |
NIL |
| Intervention |
PHYSIO GUN |
.Percussion therapy will be applied to Quadratus Lumborum muscle for 5 minutes per session at medium speed (level 2). The percussion method will be changed longitudinally in a straight line from distal to proximal and back to distal |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
LBP for more than 12 weeks
Limited range of motion of lumbar spine due to tightness of the Quadratus Lumborum.
Hypersensitive tender points on palpation
|
|
| ExclusionCriteria |
| Details |
Subjects with history of any spinal surgery
Subjects with altered sensation or spinal cord injury
Subjects with hip joint pathology.
Radiating pain due to nerve root involvement
Phobia of instruments
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical pain rating scale
Modified Schober test
Standard Goniometer for lumbar spine range of motion
Oswestry Disability Index |
At baseline second week third week and fourth week |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
There are various treatments that can be used to relieve Quadratus Lumborum (QL) muscle tightness, these treatments include stretching, muscle energy technique (MET), myofascial release therapy (MFR), positional release therapy (PRT), transverse friction massage (TFM). instrument assisted soft tissue mobilization, physio gun and foam roller are forms of myofascial release improves muscle flexibility and fascial restriction. Incorporating these tools for improving QL flexibility will help to improve lumbar spine mobility and overall functional ability. These tools are easy to use as they reduce imposed stress on the hands of a therapist, also can be used as home-based intervention and for self-care. This study will highlight the importance of targeting Quadratus Lumborum muscle and including this muscle in the treatment of LBP as it is involved as a potential source of low back pain. It will emphasize the significance of addressing Quadratus Lumborum muscle in the management of low back pain (LBP) also to evaluate the effect of Instrument assisted soft tissue mobilization, physio gun and foam roller on QL muscle flexibility, lumbar spine range of motion, functional ability and to compare the effect of each technique and determine which is more effective in the treatment of LBP.
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