| CTRI Number |
CTRI/2025/03/082465 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship of Balance with Neck Muscle Endurance, Strength and Fear of Movement in individuals with Chronic Neck Pain |
|
Scientific Title of Study
|
Association of Postural Stability with Neck Muscle Endurance, Strength and Kinesiophobia among individuals with Chronic Nonspecific 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 |
Tanveer Bhola |
| Designation |
Postgraduate Student |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Physiotherapy, SNSAH, Jamia Hamdard, Hamdard Nagar, New Delhi-110062
South
DELHI
110062
India |
| Phone |
8860229688 |
| Fax |
|
| Email |
Bholatanveer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sahar Zaidi |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Physiotherapy, SNSAH, Jamia Hamdard, Hamdard Nagar, New Delhi-110062
South
DELHI
110062
India |
| Phone |
8178071369 |
| Fax |
|
| Email |
sahar@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahar Zaidi |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Physiotherapy, SNSAH, Jamia Hamdard, Hamdard Nagar, New Delhi-110062
South
DELHI
110062
India |
| Phone |
8178071369 |
| Fax |
|
| Email |
sahar@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Rehabilitation Centre, Gate No.6, Jamia Hamdard, Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi-110062.
India |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Department of Physiotherapy, SNSAH, Jamia Hamdard, Hamdard Nagar, New Delhi-110062 |
| Type of Sponsor |
Other [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 Sahar Zaidi |
Rehabilitation Centre, Jamia Hamdard |
Room No. 9, Rehabilitation Centre, Gate No. 6, Jamia Hamdard, Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi-110062.
South
DELHI |
8178071369
sahar@jamiahamdard.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee (JHIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M542||Cervicalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Neck pain for a duration of more than three months
2. Age: 21 to 45 years
3. Both male and female
4. Chronic neck pain elicited by neck postures, neck movements, or palpation of the cervical musculature
5. Score of 3 or more on visual analog scale (VAS)
6. Neck disability score of 15 or more measured on Neck Disability Index (NDI)
|
|
| ExclusionCriteria |
| Details |
1. History of Whiplash injury or neurologic disease
2. Signs of radiculopathy
3. Cervical myelopathy
4. Tumors
5. Cervical spine infection
6. History of Cervical spine surgery
7. Rheumatic disorders
8. History of Insufficiency of the vertebrobasilar artery
9. Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Postural stability by Humac balance master system using two parameters;
- COG sway velocity (Static balance)
- Reaction time (dynamic balance).
2. Isometric neck muscle strength using MicroFET2 handheld dynamometer.
3. Cervical flexor muscle endurance by Craniocervical Flexion Test (CCFT).
4. Kinesiophobia by using Tampa Scale of Kinesiophobia (TSK).
|
At Baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
25/03/2025 |
| 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="3"
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
|
Neck pain is a widespread musculoskeletal condition affecting individuals of all age groups around the world causing an enormous burden to society. This cross-sectional study aims to determine the association of postural stability or balance with endurance and strength of neck muscles and kinesiophobia among individuals with chronic nonspecific neck pain. Purpose- Identifying a relationship between these parameters will help to strengthen the evaluation process of chronic neck pain patients and develop more comprehensive rehabilitation programs providing a holistic approach to the understanding of neck pain by addressing both physical and psychological factors. Methods- Patients visiting Rehabilitation centre, Jamia Hamdard, New Delhi with neck pain fulfilling the inclusion criteria will be included in the study and assessed for; Postural stability- Subjects will be assessed for postural stability by two parameters, COG sway velocity and Reaction time. The modified clinical test of sensory interaction will be used to assess COG sway velocity as a measure of Static balance. The test for limit of stability (LOS) will be used to assess reaction time as a measure of Dynamic balance. Isometric neck muscle strength- Neck muscle strength will be measured by using a digital hand-held dynamometer to evaluate maximum force generated. Cervical flexor muscle endurance- The Craniocervical Flexion Test (CCFT) will be performed using Pressure biofeedback Unit. Tampa scale of Kinesiophobia will be used for assessing for fear of movement in Chronic neck pain patients. |