| CTRI Number |
CTRI/2023/11/059767 [Registered on: 13/11/2023] Trial Registered Prospectively |
| Last Modified On: |
08/11/2023 |
| 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 the Effect of Maitland mobilization and Nerve Flossing along with Conventional Therapy in Cervical Radiculopathy: A randomized control trial. |
|
Scientific Title of Study
|
Comparing the Effect of Maitland mobilization and Nerve Flossing along with Conventional Therapy in Cervical Radiculopathy: A 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 |
Dr Sameeksha Sanjay Hemke |
| Designation |
Masters of Musculoskeletal Physioterapy student |
| Affiliation |
Maharashtra institute of physiotherapy latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR College Campus Vishwanathpuram latur Amajogai road Latur
Maharashtra Institute of Physiotherapy MIMSR College Campus Vishwanathpuram latur Amajogai road Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
9175861091 |
| Fax |
|
| Email |
sameekshahemke@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Bhatnagar |
| Designation |
Professor and HOD of Musculoskeletal Physiotherapy |
| Affiliation |
Maharashtra institute of physiotherapy latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR College Campus Vishwanathpuram latur Amajogai road Latur
Maharashtra Institute of Physiotherapy MIMSR College Campus Vishwanathpuram latur Amajogai road Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
7415505920 |
| Fax |
|
| Email |
bhatnagargaurav8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Bhatnagar |
| Designation |
Professor and HOD of Musculoskeletal Physiotherapy |
| Affiliation |
Maharashtra institute of physiotherapy latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR College Campus Vishwanathpuram latur Amajogai road Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
7415505920 |
| Fax |
|
| Email |
bhatnagargaurav8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Physiotherapy Latur |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical college Ambajogai Latur |
| 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 Sameeksha Hemke |
Maharashtra Institute of Physiotherapy |
Maharashtra Institute of Physiotherapy MIMSR Medical College Campus Ambajogai Latur Rd Vishwanathpuram Latur
Latur
MAHARASHTRA |
9175861091
sameekshahemke@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharashtra Institute of Physiotherapy Latur Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M501||Cervical disc disorder with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Maitland Mobilization |
Posterioanterior glide and transverse glide applies an oscillation of grade III on the most painful level for 3 sets, 30 repetitions, 5 days per week for 2 weeks for one session daily.
|
| Intervention |
Median Nerve Flossing |
The participant will be lying supine on a plinth with the right shoulder in 90° of abduction and external rotation 90° elbow flexion forearm supination wrist in neutral and fingers in extension With the neck in contralateral lateral flexion the elbow will be moved into extension
Each flossing was performed with 10 repetitions starting from neck arm elbow wrist and then whole nerve flossing
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subject with unilateral cervical neck pain and tingling-numbness present at upper limb
Subjects having Age group from 30 to 50 years
NPRS score 4 to 7/10
Males and females both to be included
Any three of the following tests must be positive-: (1) Spurling test (2) distraction test (3) ipsilateral cervical spine rotation less than 60° and (4) upper limb tension test (ULTT) for median nerve (ULTT1)- clinical predictor rule
|
|
| ExclusionCriteria |
| Details |
Systemic disease
arthritis
Spondylolisthesis
Severe Osteoporosis
Whiplash injury
Thoracic outlet syndrome
CTS
Cervical spine fracture
Canal stenosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Numerical pain rating scale
2 Cervical Range of Motion
3 Neck Disability Index |
Pre Assessment
Post Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/11/2023 |
| 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
|
Cervical Radiculopathy patients are divided in randomly two groups At the beginning of the treatment pain will be assessed on NPRS cervical range of motion using Goniometer and functional disability will be recorded with the help of NDI • Subjects in group A will be given Maitland Mobilization (PA Glide and Transverse Glide)3 sets 30 repetitions 5 days per week for 2 weeks for one session daily along with conventional physiotherapy(Isometric strengthening neck exercises with 25 repetitions 7 sec hold and strengthening exercise to the deep neck flexor muscles 10sec for 10 repetitions) • Subjects in group B will be given nerve flossing (Median nerve)Each flossing was performed with 10 repetitions starting from neck, arm, elbow, wrist and then whole nerve flossing along with conventional physiotherapy (Isometric strengthening neck exercises with 25 repetitions 7 sec hold and strengthening exercise to the deep neck flexor muscles 10 sec for 10 repetitions ) |