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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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