| 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
|
|
|
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
|
|
|
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.
|
|
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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). |