| CTRI Number |
CTRI/2025/09/095382 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| 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
|
An interventional study: Eye-cervical re-education training versus Neurodynamic exercises on pain and disability with long term non-specific neck pain patients. |
|
Scientific Title of Study
|
Comparative effectiveness of eye-cervical re-education training and neurodynamic exercises on pain and disability in patients with chronic non-specific neck pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansha Rout |
| Designation |
Postgraduate Student |
| Affiliation |
Guru Nanak Dev University |
| Address |
Guru Nanak Dev University, Department Of Physiotherapy, Amritsar,Punjab
Amritsar PUNJAB 143001 India |
| Phone |
9950233982 |
| Fax |
|
| Email |
routmansha08@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Maman Paul |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University |
| Address |
Guru Nanak Dev University, Department of Physiotherapy, Amritsar, Punjab
Amritsar PUNJAB 143001 India |
| Phone |
9815459353 |
| Fax |
|
| Email |
mamanpaul@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Maman Paul |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University |
| Address |
Guru Nanak Dev University, Department of Physiotherapy, Amritsar, Punjab
Amritsar PUNJAB 143001 India |
| Phone |
9815459353 |
| Fax |
|
| Email |
mamanpaul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Dev University, Amritsar- 143005, Punjab, India |
| Nil |
|
|
Primary Sponsor
|
| Name |
Mansha Rout |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India |
| Type of Sponsor |
Other [Myself ] |
|
|
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 Maman Paul |
Guru Nanak Dev University |
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar Amritsar PUNJAB |
9815459353
mamanpaul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Guru Nanak Dev University, Amritsar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Neck Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Eye-cervical Re-education Training
|
Eye-cervical re-education training combines excerises for ocular and cervical muscles to relieve pain, improves neck function and enhance proprioceptive feedback with chronic neck pain patients. It is performed with eyes fixed on specific target, coordinating gaze stability and neck motion. Duration of intervention will be 4 weeks. |
| Comparator Agent |
Neurodynamic Exercises |
Neurodynamic exercises uses sliders and tensioners movements to mobilize the nerves and the surrounding tissues. This aims to restore mobility, reduce symptoms and improve functions by improving circulation and reducing adhesions to facilitate normal neural function. Duration of intervention will be 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Female |
| Details |
1. Females aged between 18-28 years.
2. Females with limited range of motion at cervical region.
3. History of neck pain for more than 3 months.
4. Average experience of neck pain in last 3 months should be more than 3 points on the Visual Analogue Scale. |
|
| ExclusionCriteria |
| Details |
1. Neurological disorders affecting cervical spine.
2. Subjects with specific diagnosis such as fracture or tumor.
3. Taking analgesics or anti-inflammatory drugs or had taken 4 weeks previously.
4. Subjects having recent cervical trauma, surgery or ENT disorders |
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Cervical Pain
2.Neck Disability Index
3.Cervical Range Of Motion |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
06/10/2025 |
| 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="1" 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 "Comparative Effectiveness Of Eye-cervical Re-education Training and Neurodynamic Exercises on Pain and Disability in patients with chronic non-specific neck pain " focuses on participants aged 18-28 years who have neck pain for more than three months. This experimental study will recruit 90 participants divided into three groups : Group A (Eye-cervical Re-education Training), Group B (Neurodynamic Exercises) and Group C (Conventional Exercises for neck pain). The intervention will be administered three times a week for over four weeks, targeting parameters such as cervical pain (assessed using Visual Analogue Scale), Neck Disability (assessed using Neck Disability Index Score) and Cervical Range of Motion (measured via Goniometer). Outcomes will be assessed through pre and post interventions. This study aims to investigate the comparative effectiveness of eye cervical re-education and neurodynamic exercises in chronic non-specific neck pain patients. |