| CTRI Number |
CTRI/2025/08/092923 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Fear of Movement Affects Pain, Disability, and Daily Life in Adults with Chronic Neck Pain |
|
Scientific Title of Study
|
Fear-Avoidance Beliefs and Their Influence on Pain Intensity, Disability and
Quality of Life Among Adults with Chronic Neck Pain: A Cross-Sectional Study |
| 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 Mohammad Sidiq |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Room No Ai 217, Department of Physiotherapy, School of Allied Health Sciences,Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
6006204628 |
| Fax |
|
| Email |
sidufatima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammad Sidiq |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Room No Ai 217, Department of Physiotherapy, School of Allied Health Sciences,Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
6006204628 |
| Fax |
|
| Email |
sidufatima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Jyoti Sharma |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B 319, Department of Physiotherapy, School of Allied Health Sciences,Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9717161626 |
| Fax |
|
| Email |
jsharmaphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Galgotias Multidisciplinary Research and Development Cell, Galgotias University |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar, Uttar Pradsh, India, 203201 |
| Type of Sponsor |
Research institution |
|
|
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 Mohammad Sidiq |
Galgotias University |
Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar, Uttar Pradsh, India, 203201
Gautam Buddha Nagar
UTTAR PRADESH |
6006204628
sidufatima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Galgotias University Human Research Ethics Committee (GUHREC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Chronic Neck Pain more than 3 months duration
2.Willing to sign informed consent |
|
| ExclusionCriteria |
| Details |
o Previous cervical spine surgery
1.Neurological disorders
2.Ongoing cancer treatment
3.Major psychiatric illness
4.Pregnancy
5.Cognitive impairments
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
International Physical Activity Questionnaire
DASS-21
|
At Baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WHO-5 Wellbeing Index |
At Baseline only |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "277"
Final Enrollment numbers achieved (India)="277" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/09/2025 |
| Date of Study Completion (India) |
23/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This cross-sectional study
investigates the relationship between fear-avoidance beliefs (FAB), pain
intensity, disability, and quality of life among adults with chronic neck pain
(CNP). FAB—beliefs that physical activity will worsen pain are known to exacerbate
disability in musculoskeletal disorders but remain underexplored in CNP,
especially in South Asian populations. The study will recruit 180 adults aged
25–65 years with CNP from Department of Physiotherapy, Galgotias University.
Standardized tools, including the Visual Analog Scale (VAS), Neck Disability
Index (NDI), and Fear-Avoidance Beliefs Questionnaire (FABQ), will assess pain,
disability, and psychosocial factors. Sociodemographic variables, physical
activity levels, and symptom duration will also be analyzed. Data will undergo
correlation and regression analyses to identify predictors of pain and
disability. Findings aim to clarify FAB’s role in CNP, inform psychosocial
interventions, and guide culturally relevant rehabilitation strategies,
potentially incorporating graded activity, cognitive-behavioral therapy, and
education to improve functional outcomes and reduce chronic disability. |