| CTRI Number |
CTRI/2026/02/104737 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study Comparing Pain, Disability, and Fear Avoidance Behaviours in Men and Women with Shoulder Pain. |
|
Scientific Title of Study
|
Sex differences in pain Characteristics, Disability and fear avoidance behaviours in Individuals with Unilateral Shoulder 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 |
Hitakshi |
| Designation |
Masters of Physiotherapy Student |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy Second Floor, Manipal College of Health Professions, Manipal Academy of Higher Education ,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7814095616 |
| Fax |
|
| Email |
hitakshi.mchpmpl2025@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavitha Vishal |
| Designation |
Assistant Professor-Selection Grade |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy Second Floor, Manipal College of Health Professions, Manipal Academy of Higher Education ,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986526077 |
| Fax |
|
| Email |
kavitha.vishal@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ganesh Balthillaya M |
| Designation |
Assistant Professor-Selection Grade |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy Second Floor, Manipal College of Health Professions, Manipal Academy of Higher Education ,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448263631 |
| Fax |
|
| Email |
ganesh.bm@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hitakshi |
| Address |
Department of Physiotherapy Second Floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal-576104, Udupi Karnataka, India. |
| Type of Sponsor |
Other [SELF] |
|
|
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 Kavitha Vishal |
Manipal Academy of Higher Education |
Room no.8 Department of Physiotherapy, Kasturba Hospital, Manipal-576104 Udupi Karnataka
Udupi
KARNATAKA |
9986526077
kavitha.vishal@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age above 18-60
2.Males and females with unilateral shoulder pain
3.Ability to understand and respond to questionnaires
4.Chronic shoulder pain
|
|
| ExclusionCriteria |
| Details |
1.History of shoulder surgery
2.Pain of spinal origin
3.History of fracture or dislocation in the upper limb
4.Neurological or systemic inflammatory conditions in the upper extremity
5.Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcomes include pain characteristics and disability. Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS). Temporal pattern will be recorded as constant or intermittent. Pain sensitivity will be assessed by Pressure Pain Threshold (PPT) using a pressure algometer. Disability will be measured using the Shoulder Pain and Disability Index (SPADI). |
All primary outcomes will be assessed at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| he secondary outcome will be the level of fear-avoidance beliefs, measured using the Fear-Avoidance Beliefs Questionnaire (FABQ). |
Secondary outcome will be assessed at baseline. |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
08/03/2026 |
| 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="9"
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
|
This cross-sectional study aims to compare pain characteristics, level of disability, and fear-avoidance beliefs between males and females with unilateral shoulder pain. Pain characteristics will be assessed in terms of pain intensity, temporal pattern (constant or intermittent), and pain sensitivity. Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS), and pain sensitivity will be measured using Pressure Pain Threshold (PPT) with a pressure algometer. The level of disability will be assessed using the Shoulder Pain and Disability Index (SPADI), and fear-avoidance beliefs will be measured using the Fear-Avoidance Beliefs Questionnaire (FABQ). All assessments will be conducted at a single time point. The study aims to compare sex-based differences in pain characteristics, disability, and fear avoidance beliefs in individuals with unilateral shoulder pain. |