| CTRI Number |
CTRI/2025/11/097922 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
23/11/2025 |
| 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
|
Simple Exercises for Better Neck Health and Hand Power for cervical radiculopathy |
|
Scientific Title of Study
|
Integrating Neuromobilization versus Stabilization Exercise to improve Pain, Disability, Health related quality of life, and hand strength among Cervical Radiculopathy. |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surbhi Kaura |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
8527389589 |
| Fax |
|
| Email |
surbhi.kaura@galgotiasuniversity.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Surbhi Kaura |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
UTTAR PRADESH 203201 India |
| Phone |
8527389589 |
| Fax |
|
| Email |
surbhi.kaura@galgotiasuniversity.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Chhavi Aggarwal |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9511575012 |
| Fax |
|
| Email |
chhavi.24smas2060005@galgotiasuniversity.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Block B 3rd floor Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution |
|
|
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 Alok Prabhat |
SS HOSPITAL |
f -2, 6R56+CJM, Bhagat Singh Colony, U.I.T., Bhiwadi, Rajasthan 301019 Department of physiotherapy (basement ) Alwar RAJASTHAN |
9608927223
physioalokmishra19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research committee Galgotias university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
cervical stabilization exercises |
cervical flexion and extension dynamic isometric exercise in sitting position, bicep curls, bench press,Neck isometric
Stretching -levator scapulae , scalene
Hand exercise (hand putty squeezed in one hand , rolling putty b/w both hands)
|
| Intervention |
neruomobilization |
Neuro mobilization ( sliding of median nerve,
Neck isometric
Stretching -levator scapulae, scalene
Hand exercise (hand putty squeezed in one hand, rolling putty b/w both hands)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants aged between 18 to 50 years.
2.Limited ROM with neck pain.
3.Diagnosed by physician (MRI,CT SCAN )
|
|
| ExclusionCriteria |
| Details |
1. Congenital Cervical
2. Autoimmune neuromuscular disorder
3. Vertigo, Dizziness or Nausea
4. Cervical Artery Dysfunction
5. Osteoporosis
6. Traumatic history
7. Epilepsy
8. Any cardiac or malignancy history
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain by Visual Analog Scale
Disability by Neck disability index |
Baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Hand Strength by hand-held dynamometer
2.HrQOL by SF 36
|
baseline and 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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)
|
25/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study aims to evaluate the effectiveness of neuromobilization
and cervical stabilization exercises in improving pain, disability, hand
strength, and health-related quality of life (HrQOL) in patients with cervical
radiculopathy.
Phase 1: Screening
and Consent. Participants will be briefed on the study and screened based
on inclusion/exclusion criteria. Informed consent will be obtained.
Phase 2:
Assessment. Pain (VAS)and
disability(NDI); Hand
grip strength by hand dynamometer of both the groups.
A total of “N=64” subjects will be enrolled in the study and randomly
assigned into Group A and Group B
Group A Neuromobilization with manual therapy
This group employs a neural mobilization approach, involving median nerve
sliding, with one set of five repetitions, each held for five seconds. Using
the method by David Butler, which states that the individual was in supine
position with the shoulder in lateral rotation and abduction, with the elbow in
extension, forearm in supination, wrist, finger, and thumb in extension, and
contralateral side in flexion and shoulder in abduction for stretch.
Some additional exercises, like Neck isometric, with two sets of five
repetitions, each hold for five seconds, stretching of muscles like levator
scapulae, scalene, with five repetitions in two sets, each holding for five
seconds
With hand exercises for tingling and numbness in the arm, exercises like hand
putty squeezing, and rolling putty between both hands.
Group B Cervical Stabilization with Manual Therapy
cervical flexion and extension dynamic isometric exercise in sitting
position, bicep curls, bench press, 5 repetitions
each in two sets, each holding for five seconds
additional exercises, like Neck isometric, with two sets of five
repetitions, each hold for five seconds, stretching of muscles like levator
scapulae, scalene, with five repetitions in two sets, each holding for five
seconds
With hand exercises for tingling and numbness in the arm, exercises like
hand putty squeezing, and rolling putty between both hands.
All outcome measures will be measured at baseline and the 4th week of
the trial. Both groups received the sessions three times a week for 4 weeks.
The data will be analyzed to evaluate the best therapeutic option for
cervical radiculopathy. |