| CTRI Number |
CTRI/2025/03/083035 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Impact of Cervical Stabilization and Motor Control Exercises on Pain Disability and Mobility in Chronic Neck Pain |
|
Scientific Title of Study
|
Effectiveness of cervical stabilization and motor control exercises on
pain neck disability and range of motion in subjects with chronic neck
Pain-A comparative 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 |
Dr. Rohit Ravi Arakeri |
| Designation |
PG Student |
| Affiliation |
RV College of Physiotherapy |
| Address |
No CA 2 83 3 9th Main Rd 4th T Block East 4th Block Jayanagar Bengaluru Karnataka 560011 No CA 2 83 3 9th Main Rd 4th T Block East 4th Block Jayanagar Bengaluru Karnataka 560011 Bangalore KARNATAKA 560011 India |
| Phone |
8904892539 |
| Fax |
|
| Email |
rohitarakeri5399@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Paul Daniel Vk |
| Designation |
Professor |
| Affiliation |
RV COLLEGE OF PHYSIOTHERAPY |
| Address |
No CA 2 83 3 9th Main 4th Block Jayanagar
Bengaluru Karnataka
Bangalore KARNATAKA 560011 India |
| Phone |
9008173167 |
| Fax |
|
| Email |
pauldanielvk.rvcp@rvei.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr.Paul Daniel Vk |
| Designation |
Professor |
| Affiliation |
RV COLLEGE OF PHYSIOTHERAPY |
| Address |
No CA 2/83-3 9th Main 4th Block Jayanagar
Bengaluru Karnataka
Bangalore KARNATAKA 560011 India |
| Phone |
9008173167 |
| Fax |
|
| Email |
pauldanielvk.rvcp@rvei.edu.in |
|
|
Source of Monetary or Material Support
|
| RV College of Physiotherapy
No CA 2 83 3 9th Main 4th Block Jayanagar
Bengaluru Karnataka 560011 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| DrPaul Daniel Vk |
RV college of physiotherapy |
Department of Musculoskeletal Sciences room no 3 Bangalore KARNATAKA |
9008173167
pauldanielvk.rvcp@rvei.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RV INSTITUTION OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cervical stabilization exercises |
Subjects with neck pain tend to exhibit impaired cervical flexor muscle motor
control and strength. According to studies, those with neck pain have lower
activation of the deep cervical flexors, a smaller range of CCF range of motion,
and a greater EMG amplitude of the superficial sternocleidomastoid and
anterior scalene muscles when compared to people without neck pain.
Neck stabilization exercises will be given thrice a week for 4 weeks 30mins a
session
Each session is comprised of 5 min warm up,20 min cervical stabilization
Page 13 of 29
exercises, and 5 min cooldown
The cervical bracing technique will performed in neurodevelopment stages, and
then extremity range-of-motion exercises will given.
Cervical dynamic isometric exercises will be performed directly forward,
obliquely, toward right and left, and directly backward by maintaining a stable
spine with elastic resistive bands.
Functional training with elastic resistance and exercise balls on unstable
surfaces was performed in combination with cervical bracing. |
| Intervention |
Motor control exercises |
Cranio-cervical flexor training will be given 3 times a week for 4 weeks
The pressure biofeedback device is placed on the back of the head, and the
visual input that is collected through the devices dials is used to validate the
flattened cervical lordosis.
The pressure biofeedback beneath the subjects neck is first inflated to 20 mm
Hg. Next, the subject applies pressure at an incremental level using the sensor
dial. i.e 2 mm Hg up to 30 mmHg
The subjects will be asked to gently nod their head as if they were saying
yes
contraction continued for ten to fifteen seconds. With 3-5 rest intervals in
between each repetition, this was done ten times. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who are willing to participate as volunteers and sign the written
informed consent form
2. Subject of age group 25-50 years
3. Subjects diagnosed with Chronic neck pain
4. Subjects with a neck disability index (NDI) score of at least 10, indicating mild
to moderate disability |
|
| ExclusionCriteria |
| Details |
1. Subjects with acute neck pain.
2. Subjects with specific neck pathologies requiring surgical intervention (e.g.,
cervical spine fracture, tumors).
3. Subjects with a history of recent neck trauma (e.g., whiplash injury within the
last 6 months).
4. Subjects with neurological deficits in the upper extremities.
5. Subjects with inflammatory or infectious conditions affecting the neck.
6. Subjects with severe osteoporosis or other severe systemic diseases affecting
the neck.
7. Subjects who have undergone neck surgery in the past year.
8. Subjects with recent shoulder surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NPRS NDI |
base line and after 4 week |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
30/03/2025 |
| 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="6" 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
|
The study titled "Effectiveness of Cervical Stabilization and Motor Control Exercises on Pain, Neck Disability, and Range of Motion in Subjects with Chronic Neck Pain – A Comparative Study" aims to evaluate and compare the effects of two exercise interventions on chronic neck pain patients. Chronic neck pain is a prevalent condition that impacts daily function and quality of life. The research highlights that neck pain is associated with reduced cervical muscle strength, poor motor control, and functional impairments. Cervical stabilization exercises focus on activating deep cervical flexors to enhance stability and control, whereas motor control exercises target improving neuromuscular coordination. This study, conducted at RV College of Physiotherapy, Bengaluru, follows a non-randomized comparative parallel design with 70 participants divided into two groups receiving either cervical stabilization or motor control exercises over four weeks. Outcome measures include pain (NPRS), neck disability (NDI), and range of motion (ROM), analyzed using statistical methods. The study intends to provide insights into the most effective intervention for reducing pain and improving function in individuals with chronic neck pain, potentially guiding physiotherapy management strategies. |