| CTRI Number |
CTRI/2026/02/103620 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Pain Invalidation, Acceptance & Associated Shame in Chronic Musculoskeletal Paint Patients |
|
Scientific Title of Study
|
Pain Invalidation, Acceptance & Associated Shame in Individuals with Chronic Musculoskeletal 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 |
Mansi Khurana |
| Designation |
Mphil Clinical Psychology Trainee |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8700660923 |
| Fax |
|
| Email |
mansi.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Shwetha T S |
| Designation |
Head of Department, Associate professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9880993080 |
| Fax |
|
| Email |
shwetha.ts@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sebastian Padickaparambil |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9482916960 |
| Fax |
|
| Email |
sebastian.p@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mansi Khurana |
| Address |
Department of Clinical Psychoology, Manipal College of Health Professions, Manipal Academy of Higher Education - 576104 |
| 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 Shyamasunder Bhat N |
Manipal Academy of Higher Education |
Department of Orthopaedics, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA |
9480486705
shyambhat.n@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: M628||Other specified disorders of muscle, |
|
|
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 |
experience chronic musculoskeletal pain for atleast 3 months
18-60 years old
males and females
english or kannada reading skills |
|
| ExclusionCriteria |
| Details |
ongoing prescribed psychotropic medications
severe medical illnesses that limt participation (e.g., uncontrolled diabetes mellitus)
non-musculoskeletal chronic pain
pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identifying the relationship among pain invalidation,pain acceptance and associated shame |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
22/02/2026 |
| 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="6"
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 is a quantitative, observational, and cross-sectional study titled, "Pain Invalidation, Pain Acceptance and Associated Shame in individuals with Chronic Musculoskeletal Pain". The aim of study is to understand the relationship among pain invalidation , pain acceptance, and associated shame in patients with chronic musculoskeletal pain. The objectives are to understand pain invalidation, pain acceptance, and associated shame in patients with chronic musculoskeletal pain, and to understand the influence of socio-demographic variables and clinical correlates of chronic musculoskeletal pain among pain invalidation, pain acceptance, and associate shame in patients with chronic musculoskeletal pain. The participants would be identified from the Department of Physiotherapy and pilot study (n=10) will be carried to determine the appropriateness and feasibility of administration of the scales. The data will be processed for analysis in Jamovi software. The study expects to explore if any significant relationship exists among the key variables in the given population for future impications on non-pharmacological management of chronic musculoskeletal pain. |