| CTRI Number |
CTRI/2025/06/089620 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| 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
|
Comparing Mulligan Therapy Alone vs Mulligan with Nerve Stretching to Reduce Pain and Improve Movement in People with Lumbar Radiculopathy |
|
Scientific Title of Study
|
Effectiveness of Neurodynamic Mobilization in Adjunct to Mulligan Mobilization vs Mulligan Mobilization on Pain Range of Motion Functional Disability and Quality of Life in Patients with Lumbar Radiculopathy A Single Blinded Randomized Control Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushi Santosh Gelda |
| Designation |
Post graduate student |
| Affiliation |
Datta Meghe College of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri, Hingna Road , Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8888889141 |
| Fax |
|
| Email |
khushigelda2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapna Jawade |
| Designation |
Associate professor |
| Affiliation |
Datta Meghe College of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri, Hingna Road , Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9860677955 |
| Fax |
|
| Email |
drswapnasj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Khushi Gelda |
| Designation |
Post graduate student |
| Affiliation |
Datta Meghe College of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri, Hingna Road , Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8888889141 |
| Fax |
|
| Email |
khushigelda2001@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe College of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri, Hingna Road , Nagpur 441110 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Khushi Gelda |
Datta Meghe College of Physiotherapy and SMHRC |
Musculoskeletal Out Patient Department Shri Datta Meghe Polytechnic Campus Wanadongri Hingna Road Nagpur
Nagpur
MAHARASHTRA |
8888889141
khushigelda2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nagar Yuvak Sanstha, Datta Meghe College of Physiotherapy, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mulligan Mobilization |
Group B (Control Group) 4 week intervention The participants will be given Mulligan mobilization for low back pain with radiculopathy
The intervention will be given for 30 minutes with 3 sessions per week for 4 weeks (12 sessions)
3 sets of 30 seconds hold will be given to the participants
To conduct the intervention the patient will be in supine position on the edge of the bed
Therapist will give lumbar traction with mulligan belt
The intervention given above will be given with Physiotherapy treatment ie TENS for 10 mins, and Stretching (Calf and Hamstring muscle stretching) and Strengthening exercises (Bridging, Straight leg raise, Static Quadriceps and Hamstrings) |
| Intervention |
Neurodynamic Mobilization in adjunct to Mulligan Mobilization |
Group A (Experimental Group) 4 week intervention The participants will be given Neurodynamic mobilization combined with Mulligan mobilization for low back pain with radiculopathy
The intervention will be given for 30 minutes with 3 sessions per week for 4 weeks (12 sessions)
3 sets of 30 seconds hold will be given to the participants
To conduct the intervention the subject will be in supine position on the edge of the bed
One leg of the subject will placed on the therapist’s shoulder (such that the lower limb is flexed)
Therapist will give lumbar traction with mulligan belt and simultaneously dorsiflex the foot to perform neurodynamic mobilization of sciatic nerve
Further lumbar traction with mulligan belt and simultaneous neurodynamic mobilization is given for common peroneal nerve (plantar flexion and inversion) and tibial nerve(dorsiflexion and eversion)
The intervention given above will be given with Physiotherapy treatment ie Stretching (Calf and Hamstring muscle stretching) and Strengthening exercises (Bridging, Straight leg raise, Static Quadriceps and Hamstrings, etc) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with lumbar spondylosis who are between the ages of 25 and 60
The presence of unilateral lower limb radicular discomfort
The readiness to take part and give informed consent
Symptoms that last longer than four weeks
A decreased range of motion in the lumbar region (as determined by goniometry) |
|
| ExclusionCriteria |
| Details |
History of major spinal deformity (eg scoliosis) or spinal surgery
Surgically correcting an acute lumbar disc herniation
Deficiencies in the nervous system (eg foot drop bladder or bowel malfunction)
Pregnancy
History of nerve damaging systemic diseases (eg diabetes mellitus with neuropathy)
Individuals with lumbar radiculopathy who are now receiving any other type of physical therapy
Neurodynamic mobilization or manual therapy contraindications (eg infections malignancies fractures) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain (Numerical Pain Rating Scale)
Range of Motion (Goniometer)
Functional disability (Oswestry Disability Index)
Quality of life (Short Form 12 Questionnaire) |
The Outcome Measures will be taken before the start of the intervention and at 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/07/2025 |
| 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="1"
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
|
Lumbar radiculopathy is a common neuromusculoskeletal condition characterized by radiating pain reduced range of motion (ROM) functional limitations and decreased quality of life Manual therapy techniques like Mulligan mobilization have demonstrated benefits in alleviating symptoms but the integration of neurodynamic mobilization may provide enhanced outcomes through improved neural mobility and decreased mechanosensitivity Mulligan mobilization applies sustained accessory glides with patient movement to restore joint function and reduce pain Neurodynamic mobilization targets the neural tissues to relieve nerve tension and improve neurodynamics While both approaches have proven efficacy individually their combined impact on lumbar radiculopathy has not been sufficiently explored in clinical trials This study is among the first to assess the combined effect of neurodynamic mobilization alongside Mulligan mobilization compared to Mulligan mobilization alone The integration of two manual therapy techniques may offer a synergistic effect on neural and musculoskeletal structures Its objective is to evaluate and compare the effectiveness of neurodynamic mobilization with Mulligan mobilization versus Mulligan mobilization alone in improving pain ROM functional disability and quality of life in individuals with lumbar radiculopathy A single-blinded randomized controlled trial will be conducted involving participants diagnosed with lumbar radiculopathy Subjects will be randomly allocated into two groups receiving either the combined or single intervention Outcomes will be measured using the Numerical Pain Rating Scale (NPRS) for Pain Goniometry for ROM Oswestry Disability Index (ODI) for Functional disability and SF 36 for Quality of life |