| CTRI Number |
CTRI/2025/10/095564 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
02/10/2025 |
| 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
|
Neck Exercises with Visual Feedback for Individuals with Chronic Neck Pain |
|
Scientific Title of Study
|
Effects of Cervical Stabilization Exercises with Real Time Visual Feedback on Pain, Functional Disability and Physical Impairment in Individuals 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 Joanna Philip |
| Designation |
Post Graduate Student |
| Affiliation |
D Y Patil Deemed to be University, School of Physiotherapy |
| Address |
D Y Patil Deemed to be University, School of Physiotherapy, 6th floor, Plot No-2, sector-5, Nerul, Navi Mumbai, Maharashtra
Thane
MAHARASHTRA
400706
India |
| Phone |
9769232312 |
| Fax |
|
| Email |
iamjoanna.anna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranita Ganjave |
| Designation |
Associate Professor |
| Affiliation |
D Y Patil Deemed to be University, School of Physiotherapy |
| Address |
D Y Patil Deemed to be University, School of Physiotherapy, 6th floor, Plot No-2, sector-5, Nerul, Navi Mumbai, Maharashtra
Thane
MAHARASHTRA
400706
India |
| Phone |
9664821336 |
| Fax |
|
| Email |
pranita.ganjave@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranita Ganjave |
| Designation |
Associate Professor |
| Affiliation |
D Y Patil Deemed to be University, School of Physiotherapy |
| Address |
D Y Patil Deemed to be University, School of Physiotherapy, 6th floor, Plot No-2, sector-5, Nerul, Navi Mumbai, Maharashtra
Thane
MAHARASHTRA
400706
India |
| Phone |
9664821336 |
| Fax |
|
| Email |
pranita.ganjave@dypatil.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Joanna Philip |
| Address |
D Y Patil Deemed to be University, School of Physiotherapy, 6th Floor, Plot No-2, sector-5, Nerul, Navi Mumbai, Maharashtra - 400706 |
| 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 Joanna Philip |
D Y Patil Hospital |
Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector-5, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA |
9769232312
iamjoanna.anna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
individuals with chronic neck pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cervical stabilization Exercises with Real Time Visual Feedback |
Experimental Group will receive Cervical Stabilization Exercises with real time Visual Feedback
Control Group will receive Cervical Stabilization Exercises without real time Visual Feedback
Exercise Protocol (20 minutes)
Week 1-
Chin tuck exercises (10 seconds hold, 10 seconds rest).
3 sets of 10 reps while sitting on a backless chair.
Week 2-
Shoulder flexion exercise using a TheraBand added during chin tuck.
3 sets of 10 reps performed while sitting.
Week 3 & 4-
Same exercise as Week 2 but performed on an unstable surface (gym ball) instead of a backless chair.
Both groups will receive warm up as follows-
Participants will perform general stretching and mobility exercises-
1) Wrist and ankle rotations
2) Posterior shoulder stretching
3) Cervical flexor stretching
4) Wrist stretching
Cool-Down (5 minutes)
1) Chest stretching exercises in three positions (upper, middle, and lower).
2) Participants will lean against a wall with arms spread apart and hold the stretch for 20 seconds (3 sets).
3) Deep breathing exercises to regulate breathing and relaxation.
|
| Comparator Agent |
Control Group- Cervical Stabilization Exercises WITHOUT real time Visual Feedback. |
CONTROL GROUP will receive Cervical Stabilization Exercises WITHOUT real time Visual Feedback.
Exercise Protocol (20 minutes) Week 1-
Chin tuck exercises (10 seconds hold, 10 seconds rest). 3 sets of 10 reps while sitting on a backless chair.
Week 2-
Shoulder flexion exercise using a TheraBand added during chin tuck. 3 sets of 10 reps performed while sitting.
Week 3 & 4-
Same exercise as Week 2 but performed on an unstable surface (gym ball) instead of a backless chair.
Warm up-
Participants will perform general stretching and mobility exercises:
1) Wrist and ankle rotations
2) Posterior shoulder stretching
3) Cervical flexor stretching
4) Wrist stretching
Cool-Down (5 minutes)-
1) Chest stretching exercises in three positions (upper, middle, and lower).
2) Participants will lean against a wall with arms spread apart and hold the stretch for 20 seconds (3 sets).
3) Deep breathing exercises to regulate breathing and relaxation. |
| Comparator Agent |
Experimental Group- Cervical Stabilization Exercises WITH Real Time Visual Feedback |
EXPERIMENTAL GROUP will receive Cervical Stabilization Exercises WITH real time Visual Feedback.
Exercise Protocol (20 minutes) Week 1-
Chin tuck exercises (10 seconds hold, 10 seconds rest). 3 sets of 10 reps while sitting on a backless chair.
Week 2
Shoulder flexion exercise using a TheraBand added during chin tuck. 3 sets of 10 reps performed while sitting.
Week 3 & 4-
Same exercise as Week 2 but performed on an unstable surface (gym ball) instead of a backless chair.
Warm up-
Participants will perform general stretching and mobility exercises:
1) Wrist and ankle rotations
2) Posterior shoulder stretching
3) Cervical flexor stretching
4) Wrist stretching
Cool-Down (5 minutes)-
1) Chest stretching exercises in three positions (upper, middle, and lower).
2) Participants will lean against a wall with arms spread apart and hold the stretch for 20 seconds (3 sets).
3) Deep breathing exercises to regulate breathing and relaxation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. both male and female genders
2. patients with chronic neck pain (pain persisting more than 3 months)
3. craniovertebral angle less than 53 degrees, indicating forward head posture |
|
| ExclusionCriteria |
| Details |
1.History of surgery in the neck and shoulder regions
2.Structural spinal malformation or fractures
3.Previous neurological or surgical conditions affecting the spine
4.Recent treatment for cervical trauma or pain within the past 6 months
5.Current participation in a structured exercises program, current treatment for neck and shoulder pain, neurological symptoms of the upper extremities during screening tests (e.g., Spurling test and upper limb tension tests)
6.Presence of red flags indicating cancer, infection, vascular insufficiency, etc
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Numerical Rating Scale
2. Cervical Range of Motion
3. Cranio Cervical Flexion Test
4. Cervical Endurance Tests |
Two Time points-
1. Baseline
2. Post 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck Disability Index |
Two Time points-
1. Baseline
2. Post 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
25/10/2025 |
| 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 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
|
Chronic neck pain is a common musculoskeletal disorder associated with pain, reduced cervical mobility, functional disability, and impaired neuromuscular control. Cervical stabilization exercises are widely used to enhance deep cervical muscle activation and improve spinal stability. The integration of real-time visual feedback may further enhance motor learning and patient adherence by providing immediate self-correction during exercise performance. This study aims to evaluate the effects of cervical stabilization exercises with real-time visual feedback on pain, functional disability, and physical impairment in individuals with chronic neck pain. A randomized controlled trial design will be adopted, with participants assigned to either a visual feedback training group or a conventional exercise group. Pain will be assessed using the Numeric Rating Scale (NRS), functional disability with the Neck Disability Index (NDI), and physical impairments using CROM device for cervical range of motion, Craniocervical Flexion Test (CCFT), and cervical muscle endurance tests. The findings are expected to provide evidence on the clinical benefits of combining real-time visual feedback with stabilization exercises, potentially leading to improved rehabilitation strategies for chronic neck pain management.
|