| CTRI Number |
CTRI/2024/10/075743 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Trunk muscles activity in patients with back and neck pain |
|
Scientific Title of Study
|
Understanding the role of Anticipation in Spinal Muscle Activation patterns during shoulder movements in chronic
neck and back pain patients:
An EMG Analysis |
| 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 No. 202
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 and Professor |
| Affiliation |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room no. 202
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 |
Ritika Ria |
| Designation |
Student |
| Affiliation |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room no. 207
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Maulana Md Ali Jauhar Marg Okhla
New Delhi
South DELHI 110025 India |
| Phone |
7530966931 |
| Fax |
|
| Email |
ria.ritika5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia
Okhla
New Delhi 110025
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
India |
| 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,Jamia Millia Islamia |
Room No 02
PhD Research Lab
Ground Floor
Centre For Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Maulana Md Ali Jauhar Marg
Okhla
New Delhi 110025
India 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 |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
For healthy individuals
1. Participants aged between 18-45 years
2. Both male and female participants
For neck pain patients
1. Participants aged between 18-45 years
2. Both male and female participants
3. Chronic neck pain which lasted for more than 3 months but less than 7 years
For back pain patients
1. Participants aged between 18-45 years
2. Both male and female participants
3. CLBP lasting for more than 3 months but less than 7 years
|
|
| ExclusionCriteria |
| Details |
For healthy individuals
1. Subjects who experienced low back pain or lower limb injury within the last 5 years
2. Subjects with the history of spinal or lower limb surgery
3. Subjects having any specific sports of training habits.
4. Subjects engaged in work involving heavy loads or perturbation on the trunk
For chronic low back pain
1. spinal deformities;
2. spine surgery or participated in lumbar muscle training in the past year; or
4. any major neurological, circulatory, respiratory or orthopedic condition.
5. frank neurological loss (ie, lower extremity weakness and sensory loss),
6. pain or paresthesia below the knee,
7. pregnancy
8. leg length discrepancy,
9. vestibular dysfunction
10. OA Knee
For chronic neck pain
1. Subjects who underwent a cervical spine surgery
2. Subjects who participated in a neck exercise programme in the past 12 months
3. Spinal deformities
4. Any major neurological, circulatory, respiratory or orthopedic condition.
5. Vestibular dysfuction
6. BPPV, vertigo, balance problems
7. Pregnancy
8. Limb Length Discrepancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Electromyography activity- trunk muscles, neck muscles with respect to shoulder muscles |
At Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="39" Sample Size from India="39"
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 the community and the Centre for Physiotherapy and Rehabilitation Sciences (CPRS) clinic, Jamia Millia Islamia on the basis of the inclusion and exclusion criteria. Patients would be required to sign the consent form explaining their rights as research subjects. All the identifying information on the consent form and the demographic data shall be confidential. The assessment of the patient will include demographic data, anthropometric characteristics and screening for chronic low back pain, chronic neck pain and healthy. EMG measurements will be performed by a qualified physiotherapist. Using surface electromyography, onset latency of 8 muscles will be measured. The onset latency of the trunk muscles and the neck muscles will be calculated with reference to the activation of deltoid muscle. |
|