| CTRI Number |
CTRI/2024/05/066654 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| 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
|
Effect of Mulligan Lumbar Traction on Pain and Functional Ability in Individuals with Radiating Low Back Pain |
|
Scientific Title of Study
|
Effectiveness of Mulligans Segmental Lumbar Traction on Pain and Disability in Lumbar Radiculopathy
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devesh Mandhyan |
| Designation |
Postgraduate Student (Master of Physiotherapy) |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences |
| Address |
Room no 6, 2nd floor, Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences (Musculoskeletal), Sector C, Vasant Kunj, New Delhi.
South West DELHI 110070 India |
| Phone |
9981968988 |
| Fax |
|
| Email |
devmandhyan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Megha Nijhawan |
| Designation |
Associate Professor |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation |
| Address |
Musculoskeletal lab, 2nd floor, Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector C, Vasant Kunj, New Delhi.
South West DELHI 110070 India |
| Phone |
8802021752 |
| Fax |
|
| Email |
physiomegha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Devesh Mandhyan |
| Designation |
Postgraduate Student (Master of Physiotherapy) |
| Affiliation |
Indian Spinal Injuries Centre - Institute of Rehabilitation |
| Address |
Room no. 6, 2nd floor, Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences (Musculoskeletal), Sector C, Vasant Kunj, New Delhi.
South West DELHI 110070 India |
| Phone |
9981968988 |
| Fax |
|
| Email |
devmandhyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences, Sector C, Vasant Kunj, New Delhi.
South West DELHI,
110070, India. |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
N/A |
| 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 Devesh Mandhyan PT |
Indian Spinal Injuries Centre |
Musculoskeletal Lab, 2nd floor, Sector C, Vasant Kunj,
New Delhi - 110070
South West DELHI South West DELHI |
9981968988
devmandhyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indian Spinal Injuries Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Therapy |
Includes Stretching, Core stabilization exercises and TENS given for six sessions over the course of one week. |
| Intervention |
Mulligan Segmental Lumbar Traction |
Mulligan segmental lumbar traction will be given manually in combination with conventional therapy for six sessions over the course of one week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with unilateral lumbar
radiculopathy
2. Duration of symptoms – less than 1 year from
onset.
3. Straight leg raise test positive.
4. BMI: between 18.5 to 34.9.
|
|
| ExclusionCriteria |
| Details |
1. Patients diagnosed with any of the following:
Systemic conditions like Tumor, rheumatoid arthritis, osteoporosis, spondylolisthesis.
Neurological conditions like dementia, cognitive impairments.
Acute trauma and unhealed fractures.
2. Pregnancy.
3. Severe pain on VAS score more than 74mm.
4. Prolonged steroid use.
5. Any surgical intervention of the spine.
6. Subjects unwilling to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain score using Visual Analog Scale |
Day 0 (Baseline, Pre-test), at 1 week (Post-test) and follow up after 1 week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Centralization phenomenon using Werneke body grid chart
|
Day 0 (Baseline, Pre-test), at 1 week (Post-test) and follow up after 1 week. |
| Straight leg raise range |
Day 0 (Baseline, Pre-test) and at 1 week (Post-test) |
| Disability using Oswestry Disability Index |
Day 0 (Baseline, Pre-test), at 1 week (Post-test) and follow up after 1 week. |
|
|
Target Sample Size
|
Total Sample Size="22" Sample Size from India="22"
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)
|
15/05/2024 |
| 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="7" 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
|
Lumbar radiculopathy (LR) is a clinical syndrome characterized by
radicular pain, sensory disturbances, and motor weakness in the distribution of
a single lumbar or sacral nerve root. This pain typically radiates along a
dermatomal pattern corresponding to the affected nerve root and is often
accompanied by dermatomal sensory abnormalities, such as paresthesia and
hypoesthesia, and/or tendon reflex changes with prevalence of LR documented as high
as 25% of all lower back pain (LBP) cases. Referred symptoms, including pain, cause more significant disability
when compared to local pain alone hence, LR directly affects the functional
ability and quality of life of an individual. Existing research suggests, the potential of Mulligan manual therapy in
managing and improving the functional ability in radicular pain, both alone and
in conjunction with conventional therapies. While studies have demonstrated its
effectiveness in decreasing pain for cervical radiculopathy through the
application of segmental manual traction, its efficacy for lumbar radiculopathy
remains largely unexplored, warranting further investigation. Patients will be selected
on the basis of inclusion and exclusion criteria. They will be divided into 2
groups with the help of randomization software. One group will receive Manual Traction
on the lumbar region based on Mulligan’s Mobilization along with Conventional Therapy
for 6 sessions over 1 week. The other group which is the control, will receive
conventional therapy only.
The outcome measurements
will be done by Visual Analog Scale (VAS), Oswestry
Disability Index (ODI) version 2.1a, Body Diagram by Werneke and SLR
test ranges. Variation in the pre and post outcome measure will
help us to find out the effectiveness of
mulligan’s segmental lumbar traction on pain and disability in lumbar
radiculopathy. |