| CTRI Number |
CTRI/2025/04/084894 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| 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
|
Effectiveness of soft tissue release for chronic lower back pain |
|
Scientific Title of Study
|
Efficacy of Instrument Assisted Soft tissue mobilization for Chronic 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 |
Md Ariful Islam |
| Designation |
Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no:304, Department of Physiotherapy and Rehabilitation, Dr. M R Khan Medical Center, Jashore University of Science and Technology, Jashore, Bangladesh.
7408
Other |
| Phone |
01941716050 |
| Fax |
|
| Email |
ari948765@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Zahid Hossain |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no:410, Department of Physiotherapy and Rehabilitation, Dr. M R Khan Medical Center, Jashore University of Science and Technology, Jashore, Bangladesh.
7408
Other |
| Phone |
01670962775 |
| Fax |
|
| Email |
mz.hossain@just.edu.bd |
|
Details of Contact Person
Public Query
|
| Name |
Md Feroz kabir |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no:308, Department of Physiotherapy and Rehabilitation, Dr. M R Khan Medical Center, Jashore University of Science and Technology, Jashore, Bangladesh.
7408
Other |
| Phone |
01765932545 |
| Fax |
|
| Email |
feroz@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Dr. M R Khan Medical Center Jashore University of Science and Technology, Jashore-7408, Bangladesh. |
|
|
Primary Sponsor
|
| Name |
Md Ariful Islam |
| Address |
Room no:304, Department of Physiotherapy and Rehabilitation, Dr. M R khan Medical Center, Jashore University of Science and Technology, Jashore, Bangladesh. |
| Type of Sponsor |
Other [ [Self-Funded]] |
|
|
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 Md Tofajjal Islam Tuhin |
Musculoskeletal Physiotherapy Lab. Jashore university of Science and Technology |
Room no:301, Department of Physiotherapy and Rehabilitation, Dr. M R khan Medical Center, Jashore University of Science and Technology, Jashore, Bangladesh.
|
01778790798
yousufraju6423@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board Jashore University of Science and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional care |
Conventional physiotherapy treatments that are commonly used clinically for chronic LBP, including Mckenzie MDT approach and many other therapeutic intervention. In this study we use Mckenzie MDT approach and IRR in control group (conventional care).
• Mckenzie MDT according to patient condition:
i. Lying prone-10 min× 2 times per day.
ii. Sustain extension-10 min × 2 times per day.
iii. Repeated extension in lying- 10 Reps × 2 times per day.
iv. Repeated extension in lying with over pressure- 10 Reps × 2 times per day.
v. Lumber spine mobilization in extension- 10 Reps × 2 times per day.
vi. Rotation in extension-10 Reps × 2 times per day.
• Electrotherapy: Hot compression using IRR for 15 minutes.
|
| Intervention |
Conventional with IASTM therapy |
Position the patient in a comfortable, relaxed position, typically lying prone (face down) with the lumbar spine in a neutral position. Engage the patient in a 5-10 minute warm-up involving light aerobic activity or heat therapy . This increases blood flow to the area and prepares the tissues for mobilization. Apply a lubricant (e.g., ultrasound gel, massage oil) to the low back to allow smooth gliding of the IASTM tool over the skin. Use the IASTM tool to perform moderate-pressure strokes in different directions (longitudinal, cross-fiber, circular) . Each stroke should last between 5-10 seconds, and focus on 30 seconds to 2 minutes for each specific area of tightness or dysfunction . Start with light to moderate pressure, ensuring the patient experiences only mild discomfort, not pain.
Frequency: 2-3 times per week, for 4-6 weeks.Intensity: Moderate pressure; patient pain level should not exceed 2-3/10.Time: 30 seconds to 2 minutes per area, 10-15 minutes per session.Type: IASTM with tools, combined with stretching or other therapies.
Conventional physiotherapy treatments that are commonly used clinically for chronic LBP, including Mckenzie MDT approach and many other therapeutic intervention. In this study we use Mckenzie MDT approach and IRR in control group (conventional care).
• Mckenzie MDT according to patient condition:
i. Lying prone-10 min× 2 times per day.
ii. Sustain extension-10 min × 2 times per day.
iii. Repeated extension in lying- 10 Reps × 2 times per day.
iv. Repeated extension in lying with over pressure- 10 Reps × 2 times per day.
v. Lumber spine mobilization in extension- 10 Reps × 2 times per day.
vi. Rotation in extension-10 Reps × 2 times per day.
• Electrotherapy: Hot compression using IRR for 15 minutes.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Male and female between 18 and 60 years old; 2) Having LBP for more than 3 months; 3) Pain intensity from 3 to 7 in NPRS; 4) The written informed consent of the participants. |
|
| ExclusionCriteria |
| Details |
1) Prior Lumber spine surgery; 2) A history of congenital/acquired postural deformity, tumor, instability, inflammatory disease, spinal cord compression, fracture or infection. 3) Severe Osteoporosis, Arthritis or bone disease; 4) Unstable or severe disabling chronic cardiovascular and pulmonary disease. 5) History of serious psychological or psychiatric illness. 6) current pregnancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of motion, Disability |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
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)
|
27/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
The aim of this study is to
evaluate the efficacy of instrument-assisted soft tissue mobilization for chronic
Low Back Pain
The process I will continue, in
short:
Pt
enrollment Randomization Pre-test Post
test follow-up
After the trial
registration, the researcher will enroll the chronic low back pain
patients through the initial screening. The patient will be allocated to
two groups in the concealed process. Both groups will receive conventional
physiotherapy specifically one group receive Convention Care and another IASTM.
The researcher will measure outcomes in baseline, pretest to post-test,
and follow-up. In this study, the researcher will follow CONSORT
guidelines.
|