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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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
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.

2OBJECTIVES

Primary objectives

       To determine the effect of Positional Release Technique and Instrument Assisted Soft Tissue Mobilization on pain reduction.

       To determine the effect of Positional Release Technique and Instrument Assisted Soft Tissue Mobilization on Lumbar Range of Motion.

       To determine the effect of Positional Release Technique and Instrument Assisted Soft Tissue Mobilization on functional disability.

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.

 
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