| CTRI Number |
CTRI/2026/02/103158 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [randomized control trial] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Evaluation of Resistance Band Exercises and Foam Roller–Assisted Self-Myofascial Release in Chronic Low Back Pain |
|
Scientific Title of Study
|
A Comparative Evaluation of Resistance Band Exercises and Foam Roller–Assisted Self-Myofascial Release in Managing Disability and Quality of Life in patients with Chronic Low Back Pain. |
| Trial Acronym |
N/A |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kajal |
| Designation |
Student |
| Affiliation |
Prakash institute of physiotherapy rehabilitation & Allied medical sciences |
| Address |
PLOT N0 9A POCKET P2 SECTOR OMEGA 1 GREATER NOIDA UP
PLOT N0 9A POCKET P2 SECTOR OMEGA 1 GREATER NOIDA UP
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8791136047 |
| Fax |
|
| Email |
pkbhardwaj750087@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Puja Sharma PT |
| Designation |
Associate Professor |
| Affiliation |
Prakash Institute of Physiotherapy Rehabilitation & Allied medical sciences |
| Address |
Physiotherapy Department
Room no 302
PLOT N0 9A POCKET P2 SECTOR OMEGA 1 GREATER NOIDA UP
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9873252361 |
| Fax |
|
| Email |
S.PUJA47@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Jha PT |
| Designation |
Assistant Professor |
| Affiliation |
Prakash Institute of Physiotherapy Rehabilitation & Allied medical sciences |
| Address |
Physiotherapy Department
Room no 302
PLOT N0 9A POCKET P2 SECTOR OMEGA 1 GREATER NOIDA UP
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8527701813 |
| Fax |
|
| Email |
SHUBHAMJHA14141@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kajal |
| Address |
Prakash institute of physiotherapy rehabilitation and allied medical sciences |
| 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 Parvesh Bhardwaj |
AMARSAVITI PHYSIOTHERAPY CLINIC |
Room no 185 FIRST FLOOR PHYSIOTHERAPY DEPARTMENT GREATER NOIDA NEAR BETA PLAZA
Gautam Buddha Nagar
UTTAR PRADESH |
9058680740
amarsavitiphysiotherapyclinic@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Amarsaviti Physiotherapy Clinic |
Approved |
| Prakash Institute of physiotherapy rehabilitation and allied medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A Resistance band exercise program |
Group A Resistance Band Exercise Group
Participants will receive structured resistance band exercises targeting trunk and hip musculature including trunk flexion and extension lateral flexion hip abduction adduction bird dog side bridge and glute bridge with resistance bands
Frequency 3 sessions per week 1 supervised 2 home based
Duration 8 to 12 weeks
Progression Gradual increase in resistance and repetitions based on individual tolerance
Purpose Improve trunk muscle strength spinal stability endurance and functional ability
Group B Foam Roller Assisted SMFR Group
Participants will perform self myofascial release using foam rollers targeting lumbar paraspinals gluteal muscles piriformis hip flexors and thoracolumbar fascia
Frequency 3 sessions per week 1 supervised 2 home based
Duration 8 to 12 weeks
Progression Gradual increase in duration and pressure within comfort limits
Purpose Reduce myofascial stiffness pain improve flexibility and enhance functional performance |
| Comparator Agent |
Group B Foam roller assisted self myofacial release |
Participants allocated to the comparator group will receive a foam roller–assisted self-myofascial release program targeting the lumbar erector spinae gluteus maximus and medius piriformis hip flexors and thoracolumbar fascia. The techniques will include lumbar rolling, gluteal rolling piriformis release hip flexor self-release and thoracolumbar fascia release using a foam roller.
The intervention will be delivered three sessions per week (one supervised session and two home-based sessions) for a duration of 8–12 weeks with gradual progression in pressure and duration within safe limits. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving voluntary consent to participate
Adults age between 50 to 65 years
Chronic low back pain for more than 3 months
OSWESTRY DISABILTY INDEX more than 20 percent
Medically stable and able to perform resistance band or SMFR exercises
|
|
| ExclusionCriteria |
| Details |
Red flag conditions tumor infection fracture neurological deficit
History of spinal surgery
Severe cardiovascular respiratory or neurological illness
Pregnancy
Cognitive impairment or inability to follow instructions
Participation in structured core strengthening or resistance exercise in the past 3 months |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oswestry Disability Index |
Baseline measured post intervention 8 to 12 weeks and 3 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| visual analogue scale |
Baseline measured post intervention 8 to 12 weeks and 3 months follow up |
| Trunk Muscle Endurance Tests |
Baseline measured post intervention 8 to 12 weeks and 3 months follow up |
| SF-36 Health Survey |
Baseline measured post intervention 8 to 12 weeks and 3 months follow up |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
22/02/2026 |
| 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="0"
Months="8"
Days="15" |
|
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
|
Group A Resistance Band Exercise Group Participants will receive structured resistance band exercises targeting trunk and hip musculature including trunk flexion and extension lateral flexion hip abduction adduction bird dog side bridge and glute bridge with resistance bands Frequency 3 sessions per week 1 supervised 2 home based Duration 8 to 12 weeks Progression Gradual increase in resistance and repetitions based on individual tolerance Purpose Improve trunk muscle strength spinal stability endurance and functional ability
Group B Foam Roller Assisted SMFR Group Participants will perform self myofascial release using foam rollers targeting lumbar paraspinals gluteal muscles piriformis hip flexors and thoracolumbar fascia Frequency 3 sessions per week 1 supervised 2 home based Duration 8 to 12 weeks Progression Gradual increase in duration and pressure within comfort limits Purpose Reduce myofascial stiffness pain improve flexibility and enhance functional performance |