| CTRI Number |
CTRI/2020/06/026063 [Registered on: 23/06/2020] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Immediate effect of spinal mobilization with limb movements in patients with back pain which is radiation to the legs. |
|
Scientific Title of Study
|
Immediate effect of Mulligan’s spinal mobilization with limb movements on the SLR test in patients with lumbar radiculopathy |
| Trial Acronym |
Straight Leg Raise |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHASHWATH P NAIDU |
| Designation |
PG |
| Affiliation |
Department of Physiotherapy, M S RAMAIAH MEDICAL COLLEGE |
| Address |
93/a, 7th Cross, 4th main, Bapujinagar, Mysore road, Bangalore
DEPARTMENT OF PHYSIOTHERAPY,
M.S RAMAIAH MEDICAL COLLEGE,
M.S.R.I.T POST, BANGALORE - 54
Bangalore
KARNATAKA
560026
India |
| Phone |
8197909666 |
| Fax |
|
| Email |
shashwathspk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHASHWATH P NAIDU |
| Designation |
PG |
| Affiliation |
Department of Physiotherapy, M S RAMAIAH MEDICAL COLLEGE |
| Address |
93/a, 7th Cross, 4th main, Bapujinagar, Mysore road, Bangalore
DEPARTMENT OF PHYSIOTHERAPY,
M.S RAMAIAH MEDICAL COLLEGE,
M.S.R.I.T POST, BANGALORE - 54
Bangalore
KARNATAKA
560026
India |
| Phone |
8197909666 |
| Fax |
|
| Email |
shashwathspk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHASHWATH P NAIDU |
| Designation |
PG |
| Affiliation |
Department of Physiotherapy, M S RAMAIAH MEDICAL COLLEGE |
| Address |
93/a, 7th Cross, 4th main, Bapujinagar, Mysore road, Bangalore
DEPARTMENT OF PHYSIOTHERAPY,
M.S RAMAIAH MEDICAL COLLEGE,
M.S.R.I.T POST, BANGALORE - 54
Bangalore
KARNATAKA
560026
India |
| Phone |
8197909666 |
| Fax |
|
| Email |
shashwathspk@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy MS Ramaiah Medical College |
| Address |
DEPARTMENT OF PHYSIOTHERAPY,
M.S RAMAIAH MEDICAL COLLEGE,
M.S.R.I.T POST, BANGALORE - 54
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| SONI S |
M.S Ramaiah hospitals |
DEPARTMENT OF PHYSIOTHERAPY,
M S RAMAIAH HOSPITAL, MSRIT POST, BANGALORE--560054
Bangalore
KARNATAKA |
9740390880
soni@msrmc.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee M S Ramaiah Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M541||Radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo of spinal mobilization with limb movements |
The patient is taken into side lying with the affected limb on top. the affected leg is abducted to approximately 10 degree and supported by the second therapist or assistant. the primary therapist just places his thumb over the L4-L5-S1 spinous process with minimal pressure causing no spinal mobilization while the second therapies takes the limb into hip flexion only up to 15 degree with knees in extension by the second therapist.this is repeated three times. |
| Intervention |
spinal mobilization with limb movements |
The patient is taken in side lying position with the affected limb on top. The affected leg is abducted to approximately 10 degree and supported by the second therapist or an assistant. The primary therapist places the thumb on the side of the L4-L5-S1 spinous process and applies a downward glide, causing side flexion at that level, and rotation on the vertebra below. The other therapist moves the affected limb gently into hip flexion and knee extension while the glide is sustained. The motion must be pain free.This is repeated three times. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult population |
|
| ExclusionCriteria |
| Details |
Contraindication to manual therapy,
vertebral fractures,
spinal surgeries,
spinal deformities,
patients with recent history of fall or trauma to the spine,
patient with sudden onset of muscle weakness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Straight leg raise test |
Pre intervention and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analog scale |
Pre and post intervention |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/06/2020 |
| Date of Study Completion (India) |
05/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/04/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Suspended |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Naidu SP, Srikantaiah S, Boyle R. Immediate Effect of Mulligan’s Spinal Mobilization with Limb Movements on Straight Leg Raise Test in Patients with Lumbar Radiculopathy: A Randomized Controlled Trial. Indian Journal of Physical Therapy and Research. 2023 Jan 1;5(1):66-72. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to assess the immediate effect of spinal mobilization with limb movements on SLR test ( straight leg raise test) in patients with lumbar radiculopathy . The study is a cross sectional randomised control study. The patients will randomly be assigned to two groups, either the experimental or the control group.the experimental group will receive the spinal mobilization with limb movements while the control group will receive placebo. Both the groups will be assessed for SLR test with a digital goniometer pre and post intervention. The total sample size of 36 with 18 in each group was calculated using the minimal detectable change of SLR test which is 6 degrees. Paired t- test will be used to within the group to assess the difference in pre and post intervention SLR test angle. independent t-test will be used to compare the difference between the experimental and the control group SLR test angle. |