| CTRI Number |
CTRI/2024/10/075697 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Effect of two different Physiotherapy Intervention as an adjunct on Neck Pain |
|
Scientific Title of Study
|
Comparison of Sensorimotor Training to Scapular Stabilisation Exercises as an Adjunct in Chronic 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 |
Dr Zubia Veqar |
| Designation |
Honorary Director and Professor |
| Affiliation |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room number 202
Second Floor
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Maulana Md Ali Jauhar Marg
Okhla
New Delhi-110025
India
South
DELHI
110025
India |
| Phone |
9958993486 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zubia Veqar |
| Designation |
Honorary Director and Professor |
| Affiliation |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room number 202
Second Floor
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Maulana Md Ali Jauhar Marg
Okhla
New Delhi-110025
India
South
DELHI
110025
India |
| Phone |
9958993486 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hamda Furqan |
| Designation |
Student |
| Affiliation |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room number 207
Second Floor
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Maulana Md Ali Jauhar Marg
Okhla
New Delhi-110025
India
South
DELHI
110025
India |
| Phone |
9810867017 |
| Fax |
|
| Email |
12hamdafurqan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Okhla, New Delhi, India |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi-110025 |
| Type of Sponsor |
Other [Central University ] |
|
|
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 Zubia Veqar |
Centre for Physiotherapy and Rehabilitation Sciences |
Phyiotherapy OPD, Room number 08, Ground Floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi-110025
South
DELHI |
9958993486
veqar.zubia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jamia Millia Islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Scapular Stabilisation Exercises with Conventional Physiotherapy |
All Patients will receive 12 sessions. The Intervention will be given three times a week for four weeks.In this group scapular stabilization exercises will begin from scapular orientation and isometrics exercises, which will be given during the first week. Scapular stabilization exercises will begin at second week, along with the conventional exercises and resistive exercises in the third week and fourth week. Treatment duration will be 50-60 minutes.The exercises includes isometric exercises such as scapular pinches and low row wall isometrics and isotonics. Dynamic movements like prone shoulder and horizontal abduction are also incorporated. Additionally, resistive exercises using theraband, dynamic hug, Brugger’s exercise, manually resisted scapular strengthening, prone Y and T with weights are included. Conventional physiotherapy treatment include hot pack, IFT, neck specific therapeutic exercises. |
| Intervention |
Sensorimotor Training with Conventional Physiotherapy |
Patients in this group will perform sensorimotor exercises in addition to conventional physiotherapy treatment.Conventional physiotherapy treatment includes hot pack, IFT, neck specific therapeutic exercises. All patients will receive 12 sessions. Intervention will be given three times a week for four weeks. Treatment duration will be 50-60 minutes. Retraining joint position and movement sense with a laser pointer attached to the forehead. In this exercise, patients sit upright on a chair and keep their head at the neutral position while setting the laser light at the centre of the screen in front of them. From this position, patients will be asked to flex, extend and rotate their head and then return to the neutral position.
Occulomotor Exercises consist of eye tracking, gaze stability and eye-head coordination.
Balance Training; Patients will try to maintain their balance for 30 s in three positions including comfortable and tandem stance, and standing on a wobble board.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults between 18 to 50 years of age
2. Both male and female
3. Neck pain of duration more than 3 months and less than 7 years
4. NPRS Score from 2 to 6
5. Participants who have working knowledge of English language, for filling of questionnaires and consent form.
6. Normal or corrected to normal vision
7. Normal Hearing
|
|
| ExclusionCriteria |
| Details |
1. Patient with a history of trauma, cervical spine surgery (any other surgery will be included), whiplash, signs of cervical radiculopathy, rheumatic diseases, neurological disorders, and pain report in lumbar, hip, knee, or ankle at the same time.
2. Participants undergoing concurrent treatment for neck pain by other health care systems
3. Pain referred to neck from another part of the body
4. Hip, ankle or foot abnormalities or deformities, structural or otherwise .Ankle, knee, hip pathologies
5. Any cognitive, sensory or neurological disorders which could affect balance coordination and gait.
6. Vestibular or neuromuscular system impairment.
7.Any medical treatment that might impair balance and gait.
8.Use of any orthosis, prosthesis and assistive device.
9.Corrected to normal hearing
10.Any sleep medication
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Sleep
Sleep Quality
Daytime sleepiness
Sleep Health
Balance
1.Centre of pressure (COP) range
2.Centre of pressure (COP) sway
3.Proprioception
4.Reaction time
5.Multidirectional stability |
At Day 0 and at 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Disability
Cervical Range of Motion
Health related Quality of Life
|
At Day 0 and at 4 week |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 Patients will be recruited from Centre For Physiotherapy and Rehabilitation Sciences. Pateints will be required to sign the consent form explaining their rights as research subjects. All the identifying information on the consent form and demographic data shall be confidential. The initial assessment of the patient will include demographic data, anthropometric characteristics and screening for chronic neck pain. Baselines assessment will include measurements for neck pain intensity using NPRS, sleep quality using PSQI, daytime sleepliness using ESS, sleep health using PROMIS SD SF 8b, balance measures using the Pedalosensamove Balance Test, neck function and disability using the neck disability index, cervical range of motion using universal goniometer and health related quality of life using SF-12 will be taken. Intervention will be given thrice a week for four weeks. After which post intervention assessment will be taken again. |
 |