| CTRI Number |
CTRI/2023/08/056346 [Registered on: 09/08/2023] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective longitudinal study |
| Study Design |
Other |
|
Public Title of Study
|
Beliefs among people with persistent pain and function with upper limb pain |
|
Scientific Title of Study
|
Association of pain related beliefs with persistent pain and function in individuals with acute and subacute upper quadrant 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 |
Greeshma D shetty |
| Designation |
post graduate student |
| Affiliation |
manipal academy of higher education |
| Address |
Room no 112 Department of physiotherapy n1 orthopedics opd ,kasturba hospital ,manipal -576104
Udupi
KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
6361968490 |
| Fax |
|
| Email |
greeshma1.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
kavitha vishal |
| Designation |
Assistant Professor |
| Affiliation |
manipal academy of higher education |
| Address |
Room no 112 Department of physiotherapy n1 orthopedics opd ,kasturba hospital ,manipal -576104
Udupi
KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
9986526077 |
| Fax |
|
| Email |
kavitha.vishal@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Anupama prabhu |
| Designation |
Assistant Professor |
| Affiliation |
manipal academy of higher education |
| Address |
Room no 112 Department of physiotherapy n1 orthopedics opd ,kasturba hospital ,manipal -576104
Udupi
KARNATAKA
Udupi
KARNATAKA
576104
India |
| Phone |
9986451010 |
| Fax |
|
| Email |
anupama.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal academy of higher education |
| Address |
Manipal College of Health Professions,Manipal Academy of Higher Education ,Manipal-
576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
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 |
kasturba hospital |
Room no 112 Department of physiotherapy n1 orthopedics opd ,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 |
| Katurba medical college and kasturba hospital Institutional commitee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-65 years of age ,Non-traumatic onset of upper quadrant musculoskeletal pain ,Pain less than 12 weeks |
|
| ExclusionCriteria |
| Details |
Individuals with Post-surgical pain, Fibromyalgia, Associated Headache Pain due Systemic Diseases(rheumatic disease, neoplasms , neurological or vascular disorders)Cognitive impairment(mini cog less then 3) and Congenital disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain catastrophizing pain self efficacy , kinesiophobia ,Expectation of recovery , persistence of pain ,patient function, fear avoidance beliefs , pain intensity |
At first visit to the hospital & post 3 month pain duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
NIL |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/08/2023 |
| Date of Study Completion (India) |
15/04/2024 |
| Date of First Enrollment (Global) |
17/08/2023 |
| Date of Study Completion (Global) |
15/04/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Aim of the study is to identify pain-related beliefs influencing persistent pain and function in patients with non-traumatic acute and subacute upper quadrant musculoskeletal pain. Objective of the study is to explore the association of pain- related beliefs (Pain catastrophizing, Kinesiophobia, Self-efficacy, Fear avoidance, Expectation of Recovery) with persistent pain and function in acute and subacute upper quadrant musculoskeletal pain measured at baseline and 3 monthsParticipants will be recruited from department of physiotherapy, Kasturba hospital based on the inclusion and exclusion criteria. The study procedure will be described to the participants, and written consent will be obtained.At baseline, data including demographic details (age, gender, height, weight, education and hand dominance), clinical characteristics (duration of complaints, sites of pain recorded using body chart, Comorbidities, current treatments, pain intensity) and pain beliefs questionnaires (i.e., pain, catastrophizing, kinesiophobia ,fear avoidance, self-efficacy and expectation of recovery) will be recorded. After 3 months participants will be contacted telephonically and the pain intensity and function and pain persistence will be recorded.Data will be analysed. |