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CTRI Number  CTRI/2026/04/108647 [Registered on: 20/04/2026] Trial Registered Prospectively
Last Modified On: 08/04/2026
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   Exercise Therapy in improving low back pain 
Scientific Title of Study   Comparative efficacy of positional release technique and craniosacral therapy to improve pain in individuals with 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  Manshi 
Designation  Student (Orthopedics) 
Affiliation  Gurugram University 
Address  Department of Physiotherapy, Gurugram University, Sector 87, Gurugram, Haryana

Gurgaon
HARYANA
122505
India 
Phone  8595662017  
Fax    
Email  manshidayma835@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gurpreet Singh 
Designation  Assistant Professor 
Affiliation  Gurugram University 
Address  Department of Physiotherapy, Gurugram University, Sector 87, Gurugram, Haryana

Gurgaon
HARYANA
122505
India 
Phone  9350567096  
Fax    
Email  physio11r@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Gurpreet Singh 
Designation  Assistant Professor 
Affiliation  Gurugram University 
Address  Department of Physiotherapy, Gurugram University, Sector 87, Gurugram, Haryana

Gurgaon
HARYANA
122505
India 
Phone  9350567096  
Fax    
Email  physio11r@gmail.com   
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Gurugram University 
Address  Gurugram University Kankrola Sector 87 Gurugram Haryana 122505  
Type of Sponsor  Research institution 
 
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 Manshi PT  Department of Physiotherapy  Gurugram University Sector 87, Gurugram Haryana 122505
Gurgaon
HARYANA 
8595662017

manshidayma835@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Craniosacral therapy  3 days a week and 2 weeks 
Intervention  Positional Release Technique  3 days a week and 2 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  64.00 Year(s)
Gender  Both 
Details  1. Adult individual 18 and 45 years
2. Minimum pain score of 1
3. Pain intensity of is greater than 4 on NPRS scale
4.Low back pain of atleast 3 and 6 months
5.Disability index of more than 20 percent
6. Pressure of atleast one myofascial trigger point 
 
ExclusionCriteria 
Details  1. History of neurologic disorder Infection Seizure Inflammatory diseases
2. History of Osteoporosis recent fractures Structural deformities of spine Disc pathology Tumour Radicular symptoms
3. Recent medication injection steroid 3 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain, Range of motion  3 days a weeks and 2 week 
 
Secondary Outcome  
Outcome  TimePoints 
Functional Disability  3 days a weeks and 2 week 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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 
Date of First Enrollment (India)   20/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/04/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
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  

INTRODUCTION

BACKGROUND 

Low back pain (LBP) is a common health problem globally, managed in primary healthcare settings. A person with LBP clinically presents with discomfort, tightening of the muscles, or stiffening below the costal border and over the lower folds of the gluteal muscles, with or without discomfort in the leg. Across all age groups, LBP is one of the most prevalent musculoskeletal conditions in the general population and is the most prevalent disability among middle aged adults. Patients experience pain following their initial episode of symptoms, along with a reduction in their quality of life. LBP affects between 4% and 33% of the population at any given time, with estimates of an 80% lifetime incidence, depending on population and methodology. Several factors can result in acute LBP, including individual stance deviations, improperly functioning muscles (muscle imbalance, atrophy, or weakness), instability, joint disorders in the lower lumbar area, and injury (most often from motor vehicle accidents).


Positional Release Therapy (PRT) on the other hand is a method which uses tender points and a position of comfort to relieve the associated dysfunction. The tender point is used as a guide and the position of comfort is maintained. This prolonged shortening of the muscle causes shortening of both the intrafusal (muscle spindle) and extrafusal fibres. These changes in tum result in a significant increase in function, range of motion and a decrease in pain. PRT is an indirect manual therapy technique because its action is away from the restricted barrier into the direction of greatest ease. One advantage of PRT is that because of its gentleness and effectiveness, it is appropriate for some selected patient populations such as paediatrics, geriatrics, sports injuries, auto accidents, general orthopaedic conditions, amputees, respiratory and neurological participants

. 

Craniosacral therapy (CST) is an alternative and complementary therapy which claimed to release the tension of the muscles, ligaments, and fascia in the sacral area. CST seems to activate central pain inhibitory centers. CST is suggested for all musculoskeletal conditions particularly back pain. It was shown that CST has an effect on non-specific chronic low back pain, pelvic pain, chronic neck pain, and acute lower back pain. Craniosacral Therapy intends to normalize sympathetic nerve activity, often increased in chronic pain patients, by modifying craniosacral rhythms. While the specific mechanisms of Craniosacral Therapy are still understudied, clinical trails have shown a preliminary evidence for Craniosacral Therapy on improving patient reported outcomes such as pain and function in subjects with Non-Specific Neck Pain.


Procedure And Protocol

Participants will be divided into two groups, Group A: PRT  and Group B: CST

Group A: Positional Release Technique (PRT): This group will receive the positional release therapy with the subject lying prone.

1.Quadratus lamborum muscle: The tender points will be located on the lateral aspect of transverse processes from L1 to L5. Pressure will be applied anteriorly and then medially. The patient will be in prone with the head of the table raised or pillow placed under the patient’s chest, the examiner will standing on the opposite side of the tender point and reach across to grasp the ilium of the affected site. The examiner will then instruct the patients to flex and abduct the ipsilateral hip to approximately 45 degrees.

2. Piriformis: The tender point will found in the belly of the muscle approximately halfway between the inferior lateral angle of the sacrum and the greater trochanter. Pressure will applied interiorly. the patient will prone, and the examiner will be  standing on the tender point side. The ipsilateral leg will suspended off the table with the bent knee resting on the therapist’s thigh. The hip will flexed to 60 to 90 degree and abducted; rotation willl be used to fine-tune the position.

3. Erector spinae: This group received the positional release therapy with the subject lying prone. The subject lay prone with trunk laterally flexed towards the tender side (Plate 2). The physiotherapist stood on the side of the tender point. The physiotherapist placed the knee on the table and rested the participant s affected leg on the physiotherapist’s thigh. The participant’s hip was extended and adducted, and slight rotation was used to fine tune the muscle . This technique as performed for the erector spinae for 90 sec with 3 repetitions (270 sec).  

Group B : Craniosacral therapy (CST):  Patients will be receive 10 session of CST in 2 weeks (3 sessions per week) and each session lasts 45 minutes. A session  will contains 4 phases including in prone position, in side-lying position behind the therapist, in side-lying in front of the therapist, and in supine position. Patients will be in each position for 10 minutes. To feel and follow craniosacral movements, craniosacral therapist put her both hands on two regions or bones.

Outcome Measure:

 1.Numerical Pain Rating Scale ( NPRS) will measure pain.

2. The Oswestry Disability Index ( ODI) will measure perceived level of functional disability and quality of life impairment caused by low back pain.

3. Goniometer will measure the range of motion 


 
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