| CTRI Number |
CTRI/2025/07/091089 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of IASTM versus Myofascial Release on Pain and Thoracolumbar Fascia in Mechanical Low Back Pain |
|
Scientific Title of Study
|
Effectiveness of Instrument-assisted Soft-tissue mobilization versus Myofascial release on Pain and Morphological characteristics of thoracolumbar fascia in Mechanical low back pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ali Hossain |
| Designation |
Undergraduate Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room: 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801866116817 |
| Fax |
|
| Email |
alihossaink.23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K M Amran Hossain |
| Designation |
Lecturer |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room: 407, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801735661492 |
| Fax |
|
| Email |
kma.hossain@just.edu.bd |
|
Details of Contact Person
Public Query
|
| Name |
Dr K M Amran Hossain |
| Designation |
Lecturer |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room: 407, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801735661492 |
| Fax |
|
| Email |
kma.hossain@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Dr Ehsanur Rahman |
| Address |
Room: 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore, Bangladesh |
| Type of Sponsor |
Other [University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ehsanur Rahman |
Musculoskeletal Lab, Department of Physiotherapy and Rehabilitation |
Room: 302, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
|
8801716062263
chairman.ptr@just.edu.bd |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of Department of Physiotherapy and Rehabilitation, JUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Instrument Assisted Soft Tissue Mobilization |
Area: Thoracolumbar region (T12 to L5).
Duration: ~5–10 minutes/session.
Frequency: Single sessions per week for 4 weeks.
Tools: Stainless steel or polymer IASTM tools.
|
| Comparator Agent |
Myofascial Release |
Area: Thoracolumbar fascia.
Duration: ~10–15 minutes/session.
Frequency: 3 sessions per week for 4 weeks (total 12 sessions).
Techniques: Sustained pressure, cross-hand technique, gentle stretching.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults between 18 and 65 years
Mechanical LBP of over 3 months duration with at least ½ of days with pain over the prior 6-months (Deyo et al., 2014)
Able to understand study procedures and willing to sign an informed consent document
Willing to forgo any manual therapy treatment for LBP for the initial 4-week study period
Willing to forgo any manual therapy treatment for LBP, other than study treatments, during the 4-week treatment period
|
|
| ExclusionCriteria |
| Details |
Chiropractic care or other manual therapy treatment within 90 days
Necessary tissue layers could not be visualized with ultrasound imaging
Body Weight above 350 lbs. (158.76 kg), (safety limit for motorized table)
Unable to tolerate or safely receive study procedures
Condition identified requiring referral to another provider (e.g., suspected or confirmed abdominal aortic aneurysm, low back pain from suspected renal lithiasis)
Unable or unwilling to comply with study procedures
Current or planned pregnancy (self-reported) within the Study timeframe
Prior surgery to the thoracolumbar region
Needing a proxy
Connective tissue disorder such as Marfan and Ehlers-Danlos syndrome
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ultrasound imaging for comparing the morphological characteristics
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale (11-point)
Pressure Pain Threshold (PPT)
Oswestry Disability Index (ODI)
Roland-Morris Disability Questionnaire (RMDQ)
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="0"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
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-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kma.hossain@just.edu.bd].
- For how long will this data be available start date provided 01-09-2025 and end date provided 18-02-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized clinical trial investigates whether IASTM or MFR is more effective in reducing pain and improving the morphological characteristics (thickness, echogenicity, deformation) of the thoracolumbar fascia in patients with chronic mechanical low back pain. The study addresses a research gap by using ultrasound imaging to assess fascia changes, which has not been clearly established in prior research.
Participants (aged 18–65 with MLBP for over 3 months) will be divided into an experimental group receiving IASTM and a control group receiving MFR. Outcomes will be measured through ultrasound imaging and pain/disability scales like the Numeric Pain Rating Scale and Oswestry Disability Index. Appropriate statistical tests will compare within and between-group effects. |