| CTRI Number |
CTRI/2024/12/077744 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| 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
|
Myofascial Release versus Instrument Assisted Soft Tissue
Mobilization (IASTM) in reducing pain, improving muscle strength and
function with mechanical low back pain |
|
Scientific Title of Study
|
Comparison between Myofascial Release versus Instrument Assisted Soft Tissue
Mobilization (IASTM) in reducing pain, improving muscle strength and
function with mechanical low back pain: An Experimental 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 Chandan Kumar |
| Designation |
Professor |
| Affiliation |
Department of Physiotherapy, Galgotias University |
| Address |
Department of Physiotherapy, School of allied health sciences, Plot No. 2, Sector 17-A Yamuna Expressway, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7773923831 |
| Fax |
|
| Email |
ptchandan221@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditya yadav |
| Designation |
Scholar |
| Affiliation |
Department of Physiotherapy, Galgotias University |
| Address |
Department of Physiotherapy, School of allied health sciences, Plot No. 2, Sector 17-A Yamuna Expressway, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7773923831 |
| Fax |
|
| Email |
adityadav0603@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandan Kumar |
| Designation |
Professor |
| Affiliation |
Department of Physiotherapy, Galgotias University |
| Address |
Department of Physiotherapy, School of allied health sciences, Plot No. 2, Sector 17-A Yamuna Expressway, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7773923831 |
| Fax |
|
| Email |
ptchandan221@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, School of Allied Heath Sciences, Galgotias University, Plot No. 2, Sector 17-A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy School of Allied Health Sciences Galgotias University |
| Address |
Plot No. 2, Sector 17A Yamuna Expressway, Greater Noida, Gautam, Buddh Nagar, Uttar Pradesh, India |
| Type of Sponsor |
Other [University] |
|
|
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 |
| PROF DR CHANDAN KUMAR |
School of Allied Health Sciences |
Department of Physiotherapy, School of allied health sciences, Plot No. 2, Sector 17-A Yamuna Expressway, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
07773923831
ptchandan221@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee, Department of Physiotherapy, School of Allied Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Instrument Assisted Soft Tissue Mobilization (IASTM)
|
4 weeks, 4 day a week
Techniques:
â— Graston Technique
â— Hawkgrips
â— Fascial scraping
Treatment plan (Duration 45 minute):
1. Introduction and Assessment (5 minutes)
- Evaluate the patients pain and range of motion.
- Identify areas of tension.
2. Warm-up and Relaxation (10 minutes)
- Gentle stretching and mobilization (5 minutes)
- Deep breathing exercises (3 minutes)
- Soft tissue mobilization (2 minutes)
3. IASTM Techniques (20 minutes)
- Scrape and mobilize: 3-5 minutes per area
- 2-3 sets of 10-15 strokes per area
- Scrape and mobilize:
- Lower back (erector spinae, latissimus dorsi) (5 minutes)
- Glutes (piriformis, gluteus maximus) (5 minutes)
- Hip flexors (tensor fasciae latae, iliopsoas) (5 minutes)
- IT band and quadratus lumborum (5 minutes)
- Focus on:
- Breaking up adhesions
- Improving tissue mobility
4. Stretching and Self-Myofascial Release (5 minutes)
- Patient-performed stretches
- Foam rolling or self-myofascial release tools
5. Cool-down and Reassessment (5 minutes)
- Evaluate changes in pain and range of motion |
| Intervention |
Myofascial Release (MFR) |
Techniques:
â— Soft tissue mobilization
â— Trigger point therapy
â— Fascial stretching
â— Myofascial stretching
Treatment plan(Duration 45 minute):
1. Introduction and Assessment (5 minutes)
- Evaluate the patient's pain and range of motion.
- Identify areas of tension.
2. Warm-up and Relaxation (10 minutes)
- Gentle stretching and mobilization (5 minutes)
- Deep breathing exercises (3 minutes)
- Soft tissue mobilization (2 minutes)
3. MFR Techniques (20 minutes)
- Sustained pressure: 3-5 minutes per area
- Slow, deep strokes: 2-3 sets of 10-15 repetitions per area
- Focus on:
- Lower back (erector spinae, latissimus dorsi) (5 minutes)
- Glutes (piriformis, gluteus maximus) (5 minutes)
- Hip flexors (tensor fasciae latae, iliopsoas) (5 minutes)
- IT band and quadratus lumborum (5 minutes)
4. Stretching and Self-Myofascial Release (5 minutes)
- Patient-performed stretches
- Foam rolling or self-myofascial release tools
5. Cool-down and Reassessment (5 minutes)
- Evaluate changes in pain and range of motion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 18-45 years
2. Diagnosis of mechanical low back pain (MLBP)
3. Pain duration: ≥ 6 weeks
4. Pain intensity: ≥ 3/10 on the Numeric Pain Rating Scale (NPRS)
5. Ability to provide informed consent |
|
| ExclusionCriteria |
| Details |
1. Previous spinal surgery or instrumentation
2. Severe spinal degeneration or deformity
3. Spinal fracture or tumor
4. Neurological deficits (e.g., numbness, tingling, weakness)
5. Pregnancy or breastfeeding
6. Active inflammatory or infectious diseases
7. Recent trauma or injury to the lower back
8. Contraindications to manual therapy (e.g., bleeding disorders, osteoporosis) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale
Back Muscles strength measurement through sphygmomanometer |
0 Week
4 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry Low Back Pain Disability |
baseline- 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
21/12/2024 |
| 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="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
1. Mechanical low back pain is a prevalent condition affecting millions worldwide. 2. Current treatments have varying degrees of effectiveness, and there is a need for evidence-based alternatives. 3. MFR and IASTM are popular manual therapies, but their comparative effectiveness is unknown. 4. Limited research exists comparing MFR and IASTM for mechanical low back pain. A research study comparing Myofascial Release and Instrument Assisted Soft Tissue Mobilization is necessary because it would address a significant gap in the literature, providing clinicians with evidence-based insights on the most effective treatment strategies for managing mechanical low back pain. By exploring pain reduction, muscle strength, and functional improvement, such a study has the potential to improve patient care, reduce disability, and influence healthcare policy surrounding the treatment of low back pain. |