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CTRI Number  CTRI/2025/02/081426 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 19/02/2025
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   Effect of Total Motion Release Technique versus Lumbar Sustained Natural Apophyseal Glide (SNAGS) in Chronic Low Back Pain 
Scientific Title of Study   To Compare the Effect of Total Motion Release Technique versus Lumbar Sustained Natural Apophyseal Glide (SNAGS) in Patient 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  Dr Nirav Vaghela 
Designation  Professor 
Affiliation  K M Patel Institute of Physiotherapy 
Address  Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad, Anand, Gujarat, India. 388325

Anand
GUJARAT
388325
India 
Phone  9428647304  
Fax    
Email  niravpv@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Palak Patel 
Designation  MPT student  
Affiliation  K M Patel Institute of Physiotherapy 
Address  Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad, Anand, Gujarat, India. 388325

Anand
GUJARAT
388325
India 
Phone  9723293526  
Fax    
Email  ppalak023@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Palak Patel 
Designation  MPT student  
Affiliation  K M Patel Institute of Physiotherapy 
Address  Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad, Anand, Gujarat, India. 388325

Anand
GUJARAT
388325
India 
Phone  9723293526  
Fax    
Email  ppalak023@gmail.com  
 
Source of Monetary or Material Support  
Electrotherapy unit of physiotherapy department of K M Patel Institute of Physiotherapy Shree krishna hospital Karamsad Gujarat  
 
Primary Sponsor  
Name  Dr Palak Patel Self funded 
Address  Shree Krishna Hospital K M Patel Institute of Physiotherapy OPD no 152 Karamsad Anand Gujarat India 388325 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
nil  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 Nirav Vaghela  K M Patel Institute of Physiotherapy  Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad, Anand, Gujarat. 388325.
Anand
GUJARAT 
9428647304

niravpv@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE -2 Bhaikaka University, Karamsad, Anand, Gujarat-388325 [DHR Reg. No. EC/NEW/INST/2021/592][OHRP Reg. No. IRB00014178]  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lumbar Sustained Natural Apophyseal Glide  Lumbar SNAGS had been given to the spine at the L4 level. Sustained superior oblique glide to L4 and with passive lumbar flexion and extension movement. duration will be 5 repetition and 3 sets 10 sessions for 2 weeks Intervention will be given to participants Total Treatment duration: 30 minutes 
Intervention  Total Motion Release Technique   termed the Fab 6: (1) seated arm raise (2) standing arm press (3) seated trunk twist (4) seated leg raise (5) single-leg sit-to-stand motion and (6) bent-knee toe reach (2 sets of 20 repetitions) 10 sessions for 2 weeks Intervention will be given to participants Total Treatment duration: 30 minutes  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  age between 20 to 50 years
both male and female
Chronic pain more than 3 months will be included
chronic low back pain with radiating and non-radiating pain.
 
 
ExclusionCriteria 
Details  •If they had any recent spinal surgery, trauma or advised for surgery.
•Low Back Pain with Tingling, Numbness and Burning pain will be excluded.
•Any renal diseases, Spinal conditions like, Tumors, Spondylolisthesis, infection & spinal fracture, Systemic disease– spinal tuberculosis.
•Psychological conditions will be excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Numerical pain rating scale (NPRS)  Before and After Treatment  
 
Secondary Outcome  
Outcome  TimePoints 
Range of Motion (Assessed by the Modified Schober’s Test)  Before and After Treatment 
Oswestry disability Index (ODI)  Before and After Treatment  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   03/03/2025 
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="1"
Months="0"
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  

INTRODUCTION: The most common condition people experience in their lifetime is low back discomfort. Based on years lived with disability (YLD) measures, non-specific low back pain has been classified as the most prevalent cause of disability. It is the second most common source of reported pain after headaches. The age-related degenerative changes that occur in people between the ages of 30 to 40 years increase their risk of developing low back pain. Total Motion Release (TMR) Technique is one of the manual therapy technique. Researchers have reported that the therapeutic application of TMR has decreased pain, increased function, and restored range of motion (ROM) in the knee, low back, and shoulder, despite the fact that TMR has not been thoroughly researched in patient care. It has also been discovered that TMR application restores non-painful ROM limits. The application of Mulligan’s Mobilisation with Movement Technique (MWM) for musculoskeletal disorders, including low back pain, is becoming more and more common. One of the most significant MWM techniques, known as "sustained natural apophyseal glide" (SNAG) was invented by Brian Mulligan. An accessory passive glide is applied to the lumbar vertebrae during SNAG as the patient concurrently engages in an active movement. Both structural and functional deterioration are its symptoms. Positional defect is improved and range of motion is increased by using passive overpressure in conjunction with Brian Mulligan’s Mobilization with Movement (MWM). 

NEED OF THE STUDY: There was only single pilot study being done on studying the effects of Total Motion Release on Non - Specific low back pain where some specific postures were been practiced by the patients with LBP. We are aware that Lumbar SNAGS is also proven effective in alleviating LBP. For its practice, a therapist is required. So we would like to compare Lumbar SNAGS with this new concept i.e. TMR and would like to observe which one is more effective. If TMR found more effective it can be easily practiced by the patients and can be prescribed as home exercise program to have the extended effects/ reduced symptoms.

METHODOLOGY: Participants will be allocated randomly through computer generated random number table in two groups: Total Motion Release Technique with Conventional Therapy -group (A) and Lumbar SNAGS with Conventional Therapy - group (B). Before starting the intervention, all the participants’ baseline data will be obtained as per case report sheet. Both the groups will be assessed Before Intervention using valid Outcome Measures like Numerical pain rating scale (NPRS), Range of Motion (Assessed by the Modified Schober’s Test), Oswestry disability Index (ODI) [Annexure (4.7) (English) and Annexure (4.7) (Gujarati)]. To check the status of pain, Range of Motion and Functional ability in patients with Low Back Pain. Then, 10 sessions * 2 weeks Intervention will be given to participants. After completion of 10 sessions patients will be re-assessed by using valid Outcome Measures like Numerical pain rating scale (NPRS), Range of Motion (Assessed by the Modified Schober’s Test), Oswestry disability Index (ODI).  

 
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