| CTRI Number |
CTRI/2025/10/095634 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare two therapy methods – Positional Release Technique and Instrument-Assisted Soft Tissue Mobilization – to see which works better for reducing pain, improving lower back movement, and daily function in people with long-term mechanical low back pain. |
|
Scientific Title of Study
|
Comparative Effectiveness of Positional Release technique and Instrument Assisted Soft Tissue Mobilization on Pain, Lumbar range of motion and Function in Chronic 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 |
Adeena |
| Designation |
MPT Student |
| Affiliation |
ISIC - Institute of Rehabilitation Sciences |
| Address |
Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj New Delhi, Delhi 110070
South DELHI 110070 India |
| Phone |
09015199688 |
| Fax |
|
| Email |
adeenaangel6@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Chitra Kataria |
| Designation |
Principal, ISIC - Institute of Rehabilitation Sciences |
| Affiliation |
ISIC - Institute of Rehabilitation Sciences |
| Address |
Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj New Delhi, Delhi 110070
South DELHI 110070 India |
| Phone |
9810310670 |
| Fax |
|
| Email |
rehab@isiconline.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Chitra Kataria |
| Designation |
Principal, ISIC - Institute of Rehabilitation Sciences |
| Affiliation |
ISIC - Institute of Rehabilitation Sciences |
| Address |
Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj New Delhi, Delhi 110070
South DELHI 110070 India |
| Phone |
9810310670 |
| Fax |
|
| Email |
rehab@isiconline.org |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre, Vasant Kunj, 110070 |
|
|
Primary Sponsor
|
| Name |
Indian Spinal Injuries Centre |
| Address |
Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj New Delhi, Delhi 110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Chitra Kataria |
Indian Spinal Injuries Centre |
ISIC Physiotherapy Department South DELHI |
9810310670
rehab@isiconline.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Instrument Assisted Soft Tissue Mobilization |
The patient is asked to lie on his tummy; lubricant (Oil) will be applied to the lower back area to facilitate smooth gliding of the IASTM tool (Graston) which is made of stainless steel, allowing therapists to apply pressure to painful areas in muscles, helping to relieve pain and improve movement.
The intervention will begin with light to moderate pressure, ensuring that the patient experiences only mild discomfort without pain. IASTM will be applied for approximately 90–120 seconds on each muscle, followed by 1 minute of rest after each muscle, with the instrument held at a 45° angle. The total treatment duration will be about 15 minutes. In the remaining days, hot pack and back exercises will be given as part of conventional physiotherapy.
Treatment duration - 03 weeks |
| Intervention |
Positional Release Technique |
The patient is asked to lie on his tummy. The examiner palpates the painful points on the lateral aspect of the transverse processes from L1 to L5. The therapist then side bends and raises the hip while applying pressure to the painful point. This position is maintained for 90 seconds. The process is repeated for 2–3 repetitions for each movement, with a total duration of 15 minutes. Hot pack and back exercises will be provided in Conventional physiotherapy.
Treatment duration - 03 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with Chronic Mechanical Low back pain,
Moderate pain on VAS that persists for at least 12 weeks and presence of tender points in the lower back region.
|
|
| ExclusionCriteria |
| Details |
Participants with history of trauma or surgery, diagnosed with neurological disorder, spinal causes, systemic disease and skin conditions like petechiae, ecchymosis, allergy to metal and emollients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain (Visual Analogue Scale)
|
03 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lumbar Range Of Motion (Android/ iOS Clinometer App)
|
03 weeks |
| Oswestry Disability Index (ODI) |
03 weeks |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/10/2025 |
| 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="6" Days="0" |
|
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
|
1. Background: Chronic mechanical LBP originates from the anatomical structures of spine, intervertebral discs, and surrounding soft tissues and persists for >12 weeks. The global prevalence of chronic low back pain is substantial, with up to 23% of the population affected, and frequent episode of recurrences. Various manual therapy techniques such as Positional Release Therapy (PRT), Instrument Assisted Soft Tissue Mobilization (IASTM), Muscle Energy Technique (MET) and Myofascial Release (MFR), are utilized in the management of Chronic Mechanical Low Back Pain. IASTM and PRT both have shown significant effect on pain and range of motion in individuals with Chronic Mechanical Low Pain. 2. OBJECTIVES 3. HYPOTHESIS Null Hypothesis Ho- • There will be no significant difference in Positional Release Technique and Instrument Assisted Soft Tissue Mobilization on reduction in pain, functional disability and improving lumbar ROM in Chronic Mechanical Low Back Pain. Alternate Hypothesis H1- • There will be significant difference in Positional Release Technique and Instrument Assisted Soft Tissue Mobilization on reduction in pain, functional disability and improving lumbar ROM in Chronic Mechanical Low Back Pain. 4. Material and Methods This randomized controlled trial will be conducted on Chronic mechanical low back patients experiencing chronic low back pain, recruited from the Indian Spinal Injury Centre, New Delhi. A total of 24 participants (12 in each group) will be included based on strict inclusion and exclusion criteria. Eligible individuals will be aged 18–50 years, diagnosed with chronic mechanical low back pain and suffering from mild to moderate low back pain (VAS-3 to 6) for more than 3 months. Participants with history of trauma or surgery, diagnosed with neurological disorder, spinal causes, systemic disease and skin conditions like petechiae, ecchymosis, allergy to metal and emollients. Baseline assessments will cover pain (Visual Analogue Scale), Lumbar ROM (Android/ iOS App) and Functional disability (Oswestry Disability Index). Participants will be randomly assigned into two experiments (PRT + conventional therapy) and (IASTM + conventional therapy). The intervention will be conducted for 35 minutes per session, three times a week for three weeks. Post-intervention assessments will follow the same outcome measures. Group A: PRT + Conventional Physiotherapy The patient is asked to lie on his tummy. The examiner palpates the painful points on the lateral aspect of the transverse processes from L1 to L5. The examiner then side bends and raises the hip while applying pressure to the painful point. This position is maintained for 90 seconds. The process is repeated for 2–3 repetitions for each movement, with a total duration of 15 minutes. Hot pack and back exercises will be provided in Conventional physiotherapy. Group B: IASTM + Conventional Physiotherapy The patient is asked to lie on his tummy; lubricant (Oil) will be applied to the lower back area to facilitate smooth gliding of the IASTM tool (Graston) which is made of stainless steel, allows therapists to apply pressure to painful areas in muscles, helping to relieve pain and improve movement. The intervention will begin with light to moderate pressure, ensuring that the patient experiences only mild discomfort without pain. IASTM will be applied for approximately 90–120 seconds on each muscle, followed by 1 minute of rest after each muscle, with the instrument held at a 45° angle. The total treatment duration will be about 15 minutes. In the remaining days, hot pack and back exercises will be given as part of the conventional physiotherapy. 5. Statistical Analysis Plan: Data will be analyzed using SPSS v21.0. Normality will be tested with the Shapiro-Wilk test. Paired t-test or Wilcoxon test will be used for within-group comparisons, and independent t-test or Mann–Whitney U test for between-group comparisons. |