| CTRI Number |
CTRI/2023/11/060198 [Registered on: 23/11/2023] 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, Active Controlled Trial |
|
Public Title of Study
|
Adding physical activity program to physiotherapy program in patients with neck pain |
|
Scientific Title of Study
|
Integrating physical activity program into the rehabilitation program for patients with chronic neck pain |
| Trial Acronym |
CNP |
|
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 |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia
Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi
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 |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia
Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
9958993486 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jennifer nazir |
| Designation |
MPT student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia
Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
9541425217 |
| Fax |
|
| Email |
jennifernazir133@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Mohammed Ali Jauhar Marg, Jamia Nagar, New Delhi- 110025 |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Maulana Mohammad Ali Jauhar Marg Jamia Nagar 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 |
Room no 202, 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 , New Delhi - 110025 |
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 |
| Intervention |
conventional physiotherapy treatment + physical activity program (group 2) |
Same intervention will be given as group 1 and adding physical activity program
•Frequency-5 days/week (once in a day
•Intensity-13-14 RPE (Rate of Perceived Exertion) on 6-20 Borg Scale of Perceived Exertion
•Time-20 minutes/day for 4 weeks
• Type-Treadmill walking.
|
| Comparator Agent |
conventional physiotherapy treatment group(group1) |
1.Postural education
2.Hot pack- 5 days/ week for 15 mins over the most painful area.
3.Conventional TENS: (50 Hz, pulse duration 150 us) was applied to the neck region for 20 min, centered on the area reported as the most painful.
4.Stretching Exercises: Three repetitions of stretching exercises for neck flexor, extensor, lateral flexor, and rotator for 30 seconds as warm-up and cool-down exercises, in order to relieve tension on each side of the neck.
5.Cranio-cervical flexion (CCF) in a supine position(3 sets, 10 repetitions, 10 s of contraction each repetition with 10 s of rest).
6.CCF sitting (3 sets, 10 repetitions, 10 s of contraction each repetition with 10 s of rest.
7.Co-contraction of deep and superficial neck flexors in supine decubitus (10 repetitions, 10 s of contraction with 10 s of rest).
8.Co-contraction of flexors, rotators, and lateral flexors
(10 repetitions, 10 s of contraction with 10 s of rest).
9.Eccentric for extensors
10.Eccentric for flexors
11.Neck Isometric Exercises
12.Deep Cervical Flexor Exercise.
progression will be made according to patients tolerance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18–45 years (both males as well as females).
2.Non- radicular Chronic neck pain (> 3 months, < 7 years) (3-6 on NPRS).
3.Subjects should have knowledge of English language.
4.In addition, patients who had led a sedentary lifestyle and reported no leisure time physical activity Did you engage in any physical activity during your free time that caused you to have difficulty breathing for at least two days a week?
|
|
| ExclusionCriteria |
| Details |
1.Neck pain associated with vertigo.
2.Diagnosed psychological disorders.
3.Diagnosed with any vestibular, cardiopulmonary disorders or any medical and orthopedic condition that contraindicates physical activity program.
4.Red flags (night pain, severe muscle spasm, loss of involuntary weight, symptom mismatch)
5.Patient who underwent physiotherapy treatment in the last 3 months.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
(a)pain on NPRS
(b)disability by Neck Disability
Index(NDI)
(c)Muscle activity by Electromyogram(EMG)
(d)Physical qctivity by International Physical Activity Questionairre(IPAQ) |
pre intervention at week(0) and post intervention at week (4) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(a)Muscle strength by lafaytte dynamometer.
(b)Neck muscle endurance test by Neck flexor and extensor endurance test
(c)Sleep quality by Pittsburgh sleep quality index(PSQI)
(d)pain pressure threshold by pressure algometer
(e)Quality of life by WHOQOL-BREF. |
pre intervention at week(0) and post intervention at week (4) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
30/11/2023 |
| 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)
|
Completed |
| 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
|
Background And Need of Research: Chronic neck pain is a widespread medical condition that contributes significantly to disability globally for which the most commonly used form of treatment is based on therapeutic exercise which has had a moderate impact on people with chronic neck pain. However, there is currently little evidence to support physical activity as an effective treatment for neck pain . Objective: To investigate the effects of physical activity program in addition to conventional physiotherapy treatment in patients with chronic neck pain.
Methods: A single-blinded randomized controlled trial including 20 eligible patients will be conducted after their random allocation to either group 1 receiving conventional treatment or group 2 receiving 20 min of walking on a treadmill along with conventional treatment for 5 days per week for 4 weeks. Outcome measures will include pain, disability, muscle activity, physical activity status, muscle strength, muscle endurance, pain pressure threshold, sleep quality and quality of life at baseline (week 0) and after 4th week. Conclusion: This study will provide a better understanding of how the addition of physical activity program in addition to neck-specific conventional physiotherapy treatment affects include pain, disability, muscle activity, physical activity status, muscle strength, muscle endurance, pain pressure threshold, sleep quality and quality of life . Further, it will add knowledge for evidence-based practice and health promotion to physiotherapists in treating chronic neck pain.
Ethical Approval: The study is approved by the Institutional Ethical Committee, Jamia Millia Islamia, New Delhi, India. Ethical standards will be maintained during the study according to the Declaration of Helsinki, 1964. |