| CTRI Number |
CTRI/2025/07/090693 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| 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
|
Comparison of soft tissue release versus muscle stretching techniques in Iliosacral dysfunction among lower back pain |
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Scientific Title of Study
|
EFFECT OF FOAM ROLLING VERSUS MUSCLE ENERGY TECHNIQUE IN ILIOSACRAL DYSFUNCTION AMONG CHRONIC LOW BACK PAIN PATIENTS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rama |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no. 2, Ground Floor, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University)
Ambala
HARYANA
133207
India |
| Phone |
09518260372 |
| Fax |
|
| Email |
ramataneja.055@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amita Aggarwal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
First Floor, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University)
Ambala
HARYANA
133207
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rama |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room no. 2, Ground Floor, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University)
Ambala
HARYANA
133207
India |
| Phone |
09518260372 |
| Fax |
|
| Email |
ramataneja.055@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rama |
| Address |
Room no. 2,Ground Floor, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rama |
Physiotherapy OPD |
Room no. 114,115; First Floor, Maharishi Markandeshwar Superspeciality Hospital, Mullana, Ambala
Ambala
HARYANA |
09518260372
ramataneja.055@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharishi Markandeshwar Institute Of Medical Sciences And Research, Mullana, Ambala |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, (2) ICD-10 Condition: M258||Other specified joint disorders, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Foam Rolling |
Myofascial release of Quadratus lumborum, Hamstring and Iliopsoas for upslip, anterior and posterior innominate is given along with corrective exercise, moist heat pack and Conventional TENS |
| Comparator Agent |
Muscle Energy Technique |
Muscle Energy Technique of Quadratus lumborum, Hamstring and Iliopsoas for upslip, anterior and posterior innominate is given along with corrective exercise, moist heat pack and Conventional TENS |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 20 – 40 yrs
2. Willingness to participate and sign informed consent form
3. Both male and female
4. Individuals suffering from unilateral SI Joint dysfunction
5. Individuals suffering from Chronic low back pain (more than 3 months)
6. Include only anterior, posterior and upslip ilio-sacral dysfunction
7. Three out of five positive pain provocation tests (i.e; FABER, High Thrust, Distraction, Compression, and Gaenslen’s test)
8. Three tests out of five tests of iliac crest height, levelness of the PSISs, levelness of the ASISs, standing flex test, and Gillet test should be positive, for Anterior and posterior innominate whereas for upslip dysfunction using standing flexion test
9. VAS cut-off points of mild to moderate
|
|
| ExclusionCriteria |
| Details |
1. Skin Allergy in the thigh, lumbosacral or pelvic area
2. Recent fracture or surgery in the thigh, lumbosacral or pelvic area
3. Radiating pain with motor or sensory deficits
4. Non-cooperative patients
5. In-flare and out-flare dysfunction
6. Pregnancy
7. Other pathologies like SIJ infection, superior cluneal nerve (iliac crest) syndrome, trochanteric bursitis, and scoliosis.
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Pain: Visual Analogue Scale (VAS)
2. Pain Pressure threshold (PPT): Pressure Algometer
3. Function: Modified Oswestry Disability Index (MODI)
|
Day -1 (baseline), at the end 2 weeks and after 4 weeks (follow-up to check the carry over effect).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Leg Length: Functional Leg Length Discrepancy (LLD)
2. Quality of Life : EuroQol-5 Dimension
|
Day -1 (baseline), at the end 2 weeks and after 4 weeks (follow-up to check the carry over effect). |
|
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Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
11/08/2025 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
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Brief Summary
|
Background: Between 15% and 30% of people with mechanical low back pain are found to have Sacroiliac (SI) joint pain. The sacroiliac joint is unable to function in isolation; anatomically and biomechanically, it shares its muscles with the hip joint. In general SI joint itself is unaffected, but the musculature surrounding the joint is dysfunctional. Purpose: There are many studies that look at the treatment approaches separately, none have specifically focused on the ilio-sacral muscle level approach and compared the effects of Foam Roller and MET when used as an adjuvant therapy to improve pain and function in Chronic low back pain. Hence, the purpose of this study is to find the effect of Foam Roller versus Muscle energy technique on iliosacral dysfunction among chronic low back patients. Study design: Two-group Pre - Post Experimental design Methods: Patients with chronic low back pain due to ilio-sacral dysfunction will be recruited. Demographic details will be noted, and testing procedure will be explained. Random distribution of subjects to Group A and Group B will be done using chit method. Group A will receive Foam Roller along with corrective exercise whereas Group B will receive Muscle Energy Technique (MET) along with corrective exercise. Both interventions will be given for 2 weeks, 3 days per week (total 6 sessions). Primary Outcome measures will include pain (Visual Analog scale), Trigger point (Pressure- Pain threshold), Function (Modified Oswestry Disability Index) whereas Secondary Outcome will include Functional Leg Length Discrepancy (LLD), Quality of life (EuroQol-5 Dimension).
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