| CTRI Number |
CTRI/2024/10/075763 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Radial Nerve Mobilization with Physiotherapy in cervical spondylosis |
|
Scientific Title of Study
|
To Compare The Effectiveness of Radial Nerve Mobilization with Conventional Physiotherapy Versus Conventional Physiotherapy in Patients Cervical Spondylosis With Radial Nerve 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 |
Neetu Sharma |
| Designation |
MPT Student |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional area, sitapura, tonk road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9672852852 |
| Fax |
|
| Email |
neetu1984@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Jain |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology,Jaipur |
| Address |
Neurology Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional area, Sitapura, tonk road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9414250191 |
| Fax |
|
| Email |
dranjalijain2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Jain |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology,Jaipur |
| Address |
Neurology Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional area, Sitapura, tonk road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9414250191 |
| Fax |
|
| Email |
dranjalijain2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional area, Sitapura tonk road Jaipur, Rajasthan, India, 302022 |
|
|
Primary Sponsor
|
| Name |
Neetu Sharma |
| Address |
Gram Rampura urf kanwarpura post Beelwa, Teh, Sanganer, Jaipur,Rajasthan 302022 |
| 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 Anjali Jain |
Mahatma Gandhi Hospital, Jaipur |
Room No.14 Physiotherapy OPD, Basement
Jaipur
RAJASTHAN |
9414250191
dranjalijain2@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Mahatma Gandhi Medical College and Hospital, MGUMST, Jaipur |
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 |
Only Conventional Physiotherapy |
Moist pack, strengthening neck exercise, cervical
retraction and protraction The total duration of the treatment program will be 4 weeks with 3 sessions per week.The
reassessment will be done . |
| Intervention |
Radial Nerve Mobilization with Conventional Physiotherapy |
Patient lying supine position at the end of the bed Shoulder
abducted and internally rotated as much as and scapula should be stabilized , elbow extension,
forearm pronation, wrist flexion, ulnar deviation, finger and thumb flexion and neck sideflexed
and rotated to opposite side
Conventional physiotherapy Moist pack , strengthening neck exercise and cervical
retraction and protraction. The total duration of the treatment program will be 4 weeks with 3 sessions per week.The
reassessment will be done |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cervical radiculopathy more than 4 weeks
Spurling’s test positive
Distraction test
Upper limb tension test 2b
Unilateral upper extremity pain |
|
| ExclusionCriteria |
| Details |
Subjects with median and ulnar nerve radiculopathy not involved
Fracture
Whiplash injury
Cervicogenic headache
Congenital spine curvature disorder
Thoracic outlet syndrome
Vertigo
Traumatic injuries |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Neck Disability Index |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The eligibility of the candidate will be taken from the basis of inclusion criteria.
40 Samples will be categorized into two groups with 20 individuals each and will be studied
for 4 weeks.
Group – A The patients will perform Radial nerve mobilization along with conventional
physiotherapy.
Group – B The patients will perform only conventional physiotherapy.
Treatment would be done under supervision with consent form.
Group –A
Radial nerve mobilization: patient lying supine position at the end of the bed. Shoulder
abducted and internally rotated as much as and scapula should be stabilized , elbow extension,
forearm pronation, wrist flexion, ulnar deviation, finger and thumb flexion and neck sideflexed
and rotated to opposite side.
Conventional physiotherapy: Moist pack , strengthening neck exercise and cervical
retraction and protraction.
Group -B
Only Conventional physiotherapy: Moist pack, strengthening neck exercise, cervical
retraction and protraction.
The total duration of the treatment program will be 4 weeks with 3 sessions per week.The
reassessment will be done . |