| CTRI Number |
CTRI/2025/08/092925 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| 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
|
Impact of Combined hold relax PNF and Neck stabilization exercises versus Neck stabilization exercises on pain and stability in patient with radiating neck pain A randomized clinical study |
|
Scientific Title of Study
|
Effect of Neck stabilization exercises with hold relax PNF versus Neck stabilization exercises on pain and stability in patient with radiating neck pain A randomized clinical study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi M S |
| Designation |
Physiotherapist |
| Affiliation |
cauvery college of physiotherapy |
| Address |
Department of neuroscience, 1st floor, building 1 cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
Department of neuroscience, 1st floor, building 1 cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
Mysore
KARNATAKA
570028
India |
| Phone |
8197390468 |
| Fax |
|
| Email |
nidhinidhi15133@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh M |
| Designation |
Associate professor |
| Affiliation |
cauvery college of physiotherapy |
| Address |
Department of neuroscience , 1st floor, building 1 cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
Department of neuroscience, 1st floor, building 1 cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
Mysore
KARNATAKA
570028
India |
| Phone |
7795771545 |
| Fax |
|
| Email |
rakeshmanju098@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi M S |
| Designation |
Physiotherapist |
| Affiliation |
cauvery college of physiotherapy |
| Address |
Department of neuroscience, 1st floor, building 1 cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
Department of neuroscience, 1st floor, building 1 cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
Mysore
KARNATAKA
570028
India |
| Phone |
8197390468 |
| Fax |
|
| Email |
nidhinidhi15133@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cauvery college of physiotherapy
department of neuroscience 1st floor, building 1, KBL Layout near devegowda circle mysore karnataka 570028 |
|
|
Primary Sponsor
|
| Name |
Nidhi M S |
| Address |
Deparment of neuro science, 1st floor, building 1, cauvery college of physiotherapy, KBL layput near devegowda circle mysore karnataka 570028 |
| Type of Sponsor |
Other [private college ] |
|
|
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 Rakesh M PT |
OPD cauvery college of physiotherapy |
Department of neuroscience, 1st floor, building 1 cauvery college of physiotherapy, KBL layout near deveygowda circle mysore
Mysore
KARNATAKA |
7795771545
rakeshmanju098@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee cauvery heart and multispeciality hospital, mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Radiating neck pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neck stabilization exercise |
Neck stabilization exercise is give for 15 repetition with 3 sets for 3 session per week for 4 weeks |
| Intervention |
Neck stabilization exercises with hold relax PNF |
Neck stabilization exercises is give for 15 reps with 3 sets for 3 session per week for 4 weeks and hold relax PNF is give for 5 reps with 3 sets for 3 session per week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
individual aged between 18 to 45 years
patients presenting with radiating neck pain for more than 4 weeks, with radiating pain
positive spurling and cervical distraction test
VAS from 4 to 7
both male and female
Reduced 20 percentage of cervical ROM in two or three plane |
|
| ExclusionCriteria |
| Details |
Previous cervical spine surgery, trauma, or fracture
Severe neurological disorders
Recent shoulder surgery or upper limb musculoskeletal injuries in past 3 months
Participation in formal neck or shoulder strength training within the last 6 months
Participants taking medicine for pain
Diagnosis of vestibular disorders or significant balance impairments unrelated to neck pain |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale |
Pre and post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pressure Biofeedback Unit |
Pre and post |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
23/08/2025 |
| 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="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This randomized clinical study will aim to evaluate the effect of neck stabilization exercises combined with Hold- Relax PNF versus Neck stabilization exercise on pain and stability in patients with radiating neck pain. Participants will be randomly allocated into two group: one receiving neck stabilization exercise along with Hold-Relax PNF and the other receiving only neck stabilization exercises. The intervention will be carried out over a 45 min of each with 3 session a week for 4 weeks and outcome measure such as pain and stability will be assessed pre and post intervention using VAS and Pressure Biofeedback unit.
|