| CTRI Number |
CTRI/2025/06/088145 [Registered on: 03/06/2025] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| 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 comparative study of SNAG versus Mulligan’s Bent Leg Raise technique along with traditional physiotherapy in patients with non-specific mechanical low back pain |
|
Scientific Title of Study
|
A Randomized Comparative Study to Evaluate the Efficacy of Sustained Natural Apophyseal Glide Versus Mulligans Bent Leg Raise Technique Along With Traditional Physiotherapy in Patients With Non Specific Mechanical Low Back Pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohan Bhardwaj |
| Designation |
Post Graduate Student |
| Affiliation |
Shri Guru Ram Rain University School Of Paramedical and Allied Health Sciences |
| Address |
Shri Mahant Indiresh Hospital Department Of Physiotherapy North Block Basement
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9579939682 |
| Fax |
|
| Email |
bhardwajrohan21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Kumar PT |
| Designation |
Assistant Professor |
| Affiliation |
Shri Guru Ram Rain University School Of Paramedical and Allied Health Sciences |
| Address |
Shri Mahant Indiresh Hospital Department Of Physiotherapy North Block Basement
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9412468744 |
| Fax |
|
| Email |
drskumarmalik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohan Bhardwaj |
| Designation |
Post Graduate Student |
| Affiliation |
Shri Guru Ram Rain University School Of Paramedical and Allied Health Sciences |
| Address |
Shri Mahant Indiresh Hospital Department Of Physiotherapy North Block Basement
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9579939682 |
| Fax |
|
| Email |
bhardwajrohan21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Guru Ram Rai University, School of Paramedical and Allied Health Sciences.
Pathribag, Dehradun, Uttrakhand,248001 |
|
|
Primary Sponsor
|
| Name |
Rohan Bhardwaj |
| Address |
Shri Guru Ram Rai University, School of Paramedical and Allied Health Sciences. Pathribag, Dehradun, Uttrakhand,248001
|
| 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 Rohan Bhardwaj |
Shri Mahant Indiresh Hospital |
Shri Guru Ram Rai University,Shri Mahant Indiresh Hospital, North block Basement, Dehradun,248001
Dehradun
UTTARANCHAL |
9579939682
bhardwajrohan21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe(IEC) SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HEALTH SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mulligan’s Bent Leg Raise (BLR) Technique with Traditional Physiotherapy |
Participants in this group will receive Mulligan’s Bent Leg Raise (BLR) technique performed in supine lying with hips and knees flexed, supported on the therapist’s shoulder. Each session includes 10 minutes of Interferential Therapy (IFT) in crossfire mode, followed by a moist heat pack. Post-technique, spinal and core strengthening exercises are provided.
3 sessions per week for 4 weeks (12 sessions total) |
| Intervention |
Sustained Natural Apophyseal Glide (SNAG) with Traditional Physiotherapy |
Participants in this group will receive Sustained Natural Apophyseal Glide (SNAG) applied in prone and quadruped positions by a trained physiotherapist. Each session includes 10 minutes of Interferential Therapy (IFT) in crossfire mode, followed by a moist heat pack. After SNAG application, spinal strengthening and core stabilization exercises will be conducted.
3 sessions per week for 4 weeks (12 sessions total)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both males and females
Patients with non-specific Mechanical low back pain
|
|
| ExclusionCriteria |
| Details |
1.Fracture
2.Tumors
3.Infection
4.Inflammatory diseases
5.Individuals with neurological deficits
6.Chronic pathological pain
7.Conditions that could affect their ability to participate in the exercises.
8.Patients who had undergone previous surgical interventions for low back pain.
9.Any contraindication to physiotherapy & manual therapy.
10.Those who were currently receiving other forms of treatment for low back pain that could confound the results.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
NPRS -Numeric Pain Rating Scale
ODI-Oswestry Disability Index
GONIOMETER
Straight Leg Raise (SLR) test |
Baseline (Day 0)
Mid-intervention (on 15th day)
post intervention (on 30th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
13/06/2025 |
| 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
|
This randomized comparative experimental study aims to evaluate and compare the effectiveness of two manual therapy techniques Sustained Natural Apophyseal Glide SNAG and Mulligans Bent Leg Raise BLR when used alongside traditional physiotherapy in the treatment of non specific mechanical low back pain NSMLBP. A total of 58 participants aged 18 to 60 years will be randomly assigned into two equal groups. Group A will receive SNAG with traditional physiotherapy while Group B will receive Mulligans BLR technique with traditional physiotherapy. Both groups will undergo treatment three times per week for four weeks. Outcome measures including pain measured by Numeric Pain Rating Scale NPRS functional disability assessed by Oswestry Disability Index ODI lumbar range of motion measured by goniometry and the Straight Leg Raise SLR test will be assessed at baseline mid intervention second week and post intervention fourth week. The study seeks to determine which manual therapy approach provides superior clinical outcomes in pain relief mobility and functional improvement in patients with NSMLBP. |