| CTRI Number |
CTRI/2025/02/080878 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| 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
|
Impact of Spinal Mobilization with Limb Movement on Pain, Nerve Function, and Mobility in Lumbar Canal Stenosis Patients |
|
Scientific Title of Study
|
Effect of spinal Mobilization with limb movement (SMWLM) on pain, nerve conduction velocity of common peroneal nerve, neurogenic claudication, range of motion of lumbar spine and functional activities in patients with lumbar canal stenosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kajal Yadav |
| Designation |
Student |
| Affiliation |
PG Student |
| Address |
Budhera, Gurugram-Badli Road, Gurugram-122505, Haryana, India
Gurgaon
HARYANA
122505
India |
| Phone |
8700036186 |
| Fax |
|
| Email |
kjlyadav04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddhartha Sen |
| Designation |
Professor |
| Affiliation |
Professor |
| Address |
Budhera, Gurugram-Badli Road, Gurugram-122505, Haryana, India
Gurgaon
HARYANA
122505
India |
| Phone |
9412985124 |
| Fax |
|
| Email |
siddhartha_fphy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Kajal Yadav |
| Designation |
Student |
| Affiliation |
PG Student |
| Address |
Budhera, Gurugram-Badli Road, Gurugram-122505, Haryana, India
Gurgaon
HARYANA
122505
India |
| Phone |
8700036186 |
| Fax |
|
| Email |
kjlyadav04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy,SGT University, Chandu Budhera village 122505 |
|
|
Primary Sponsor
|
| Name |
Kajal Yadav |
| Address |
Budhera, Gurugram-Badli Road, Gurugram-122505, Haryana, India |
| 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 |
| Kajal Yadav |
SGT Hospital |
Room No. 13, Department of physiotherapy, Chandu Budhera
Gurgaon
HARYANA |
8700036186
kjlyadav04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Faculty of Physiotherapy |
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 |
Lumbar flexion exercise Group |
Exercises: hamstring Stretch, bridging, single knee to chest, double knee to chest and posterior pelvic tilt. |
| Intervention |
Spinal Mobilization with Limb Movement |
spinal Mobilization
Exercises: Hamstring Stretch, bridging, single knee to chest, double knee to chest and posterior pelvic tilt.
All exercises will be performed 3 times per week for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Pre-diagnosed patients with lumbar canal stenosis
2.Patients with their MRI suggesting LSS AP diameter less than 12mm & lateral recess diameter less than 7mm.
3.Patients presenting with Neurogenic Claudication include pain in the buttock, groin, and anterior thigh, which radiates to the posterior part of the leg to the feet and leg symptoms like cramps, fatigue, heaviness, weakness and/or paraesthesia on the basis of assessment. |
|
| ExclusionCriteria |
| Details |
1. Any previous history of spinal surgeries like laminectomy or spinal fractures.
2. Patients with cardiac or pulmonary disease.
3. Patients with any kind of spinal deformity (hyperlordosis, kyphosis, scoliosis)
Vascular claudication
4. Any predisposing disease such as cancer, diabetes, renal failure, tumor, pregnancy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain, range of motion of lumbar spine, neurogenic claudication, nerve conduction velocity of common peroneal nerve |
Day 1 assessment after 2 weeks assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional activities |
Day 1 assessment after 2 weeks assessment |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
23/02/2025 |
| 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="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
|
Low back pain (LBP) is a widespread issue, with Lumbar Spinal Stenosis (LSS) being a key contributor, affecting around 20% of LBP patients. LSS is a condition where the spinal canal narrows, leading to nerve compression, pain, and sensory disturbances, particularly in the lower back and legs, and is common in older adults. It is diagnosed using clinical assessments and imaging techniques like MRI or CT scans. There are two types of stenosis: central and lateral, each caused by different structural changes in the spine. Electromyography (EMG) and Nerve Conduction Studies (NCS) are often used to evaluate nerve damage in these patients. Spinal mobilization with leg movement (SMWLM), a technique involving spinal mobilization combined with leg movement, is suggested for treating leg pain from low back issues, but no studies have investigated its effect on LSS specifically. This study aims to explore the impact of SMWLM on patients with lumbar canal stenosis. Hypothesis: Null Hypothesis · H01: There will be no significant effect of spinal mobilization with limb movement on pain in patients with lumbar canal stenosis. • H02: There will be no significant effect of spinal mobilization with limb movement on nerve conduction velocity in patients with lumbar canal stenosis. • H03: There will be no significant effect of spinal mobilization with limb movement on neurogenic claudication in patients with lumbar canal stenosis. • H04: There will be no significant effect of spinal mobilization with limb movement on nerve range of lumbar spine in patients with lumbar canal stenosis • H05: There will be no significant effect of spinal mobilization with limb movement on functional activities in patients with lumbar canal stenosis. Alternate Hypothesis · H1: There will be any significant effect of spinal mobilization with limb movement on pain in patients with lumbar canal stenosis. • H12: There will be any significant effect of spinal mobilization with limb movement on nerve conduction velocity in patients with lumbar canal stenosis. • H13: There will be any significant effect of spinal mobilization with limb movement on neurogenic claudication in patients with lumbar canal stenosis. • H14: There will be any significant effect of spinal mobilization with limb movement on range of lumbar spine in patients with lumbar canal stenosis. • H15: There will be any significant effect of spinal mobilization with limb movement on functional activities in patients with lumbar canal stenosis.
|