| CTRI Number |
CTRI/2025/07/091032 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Relationship between body fat and pain measures in patients with shoulder pain – A cross-sectional study |
|
Scientific Title of Study
|
Relationship between body composition and pain measures in individuals with chronic 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 |
Nithika |
| Designation |
MPT student |
| Affiliation |
Manipal College of Health Professionals |
| Address |
Room no 215 Department of Physiotherapy Second floor Manipal College of Health Professions Manipal Academy of Higher Education Madhav Nagar Manipal 576104
Udupi
Karnataka
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9113523535 |
| Fax |
|
| Email |
nithika.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Kavitha Vishal |
| Designation |
Assistant professor- selection grade |
| Affiliation |
Manipal College of Health Professionals |
| Address |
Department of Physiotherapy Second floor Manipal College of Health Professions Manipal Academy of Higher Education Madhav Nagar Manipal 576104
Udupi
Karnataka
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9986526077 |
| Fax |
|
| Email |
kavitha.vishal@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Kavitha Vishal |
| Designation |
Assistant professor- selection grade |
| Affiliation |
Manipal College of Health Professionals |
| Address |
Department of Physiotherapy Second floor Manipal College of Health Professions Manipal Academy of Higher Education Madhav Nagar Manipal 576104
Udupi
Karnataka
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9986526077 |
| Fax |
|
| Email |
kavitha.vishal@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room no 215 Department of Physiotherapy Second floor Manipal College of Health Professions Manipal Academy of Higher Education Madhav Nagar Manipal 576104
Udupi
Karnataka
576104
India |
|
|
Primary Sponsor
|
| Name |
Nithika |
| Address |
Manipal College of Health Professionals Manipal Academy of Higher Education, Madhav Nagar Manipal 576104 |
| Type of Sponsor |
Other [Self funded by the primary investigator] |
|
|
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 Nithika |
Manipal Academy of Higher Education |
Physiotherapy OPD N1, Baliga block, Kasturba Hospital, Manipal- 576104
Udupi
KARNATAKA |
9113523535
nithika.mchpmpl2024@learner.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 - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M759||Shoulder lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Chronic unilateral shoulder pain: shoulder pain more than 3 months |
|
| ExclusionCriteria |
| Details |
Neck pain or pain radiating below elbow
Diagnosed psychiatric condition
History of chronic pain disorders (irritable bowel syndrome, fibromyalgia, temporomandibular disorders)
Upper limb fractures, shoulder instability, tumor or infection
Open wounds, skin lesions around the shoulder region
History of steroid infiltration to the shoulder in the past 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain measures- intensity and sensitivity
Body fat %, visceral fat level, skeletal muscle % |
On the day of assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BMI |
On the day of assessment |
| Resting metabolism |
On the day of assessment |
| Body age |
On the day of assessment |
| Segmental analysis |
On the day of assessment |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
Final Enrollment numbers achieved (Total)= "85"
Final Enrollment numbers achieved (India)="85" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/07/2025 |
| Date of Study Completion (India) |
23/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
23/01/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
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 study
seeks to examine the association between body composition- specifically muscle
mass, fat levels and body mass index (BMI)- and pain- related outcomes,
including pain intensity and sensitivity, in individuals experiencing chronic
unilateral shoulder pain. A total of 85 participants with long standing
shoulder pain affecting one side will be recruited. Body composition will be
assessed using bioelectrical impedance analyser. Pain intensity will be
measured using Numerical Pain Rating Scale (NPRS), and pain sensitivity will be
evaluated using pressure pain threshold measurements obtained through a
pressure algometer. The resulting data will be analysed to determine potential
correlations between body composition parameters and pain measures. |