| CTRI Number |
CTRI/2025/07/090739 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
How a program that teaches and encourages ways to protect your hand joints can help reduce pain and improve daily activities for people with rheumatoid arthritis. |
|
Scientific Title of Study
|
Effect of educational and behavioural hand joint protection program on pain and functional activities in people with rheumatoid arthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sridevi C Hiremath |
| Designation |
Postgraduate student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD number 13
Community Physiotherapy department
SDM college of medical sciences and hospital
Manjushree Nagar Sattur
Dharwad
Karnataka India
Dharwad
KARNATAKA
580009
India |
| Phone |
7892513306 |
| Fax |
|
| Email |
shridevihmath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sridevi C Hiremath |
| Designation |
Postgraduate student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD number 13
Community Physiotherapy department
SDM college of medical sciences and hospital
Manjushree Nagar Sattur
Dharwad
Karnataka India
Dharwad
KARNATAKA
580009
India |
| Phone |
7892513306 |
| Fax |
|
| Email |
shridevihmath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Salima Bijapuri |
| Designation |
Professor and PG guide |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD number 13
Community Physiotherapy department
SDM college of medical sciences and hospital
Manjushree Nagar Sattur
Dharwad
Karnataka India
Dharwad
KARNATAKA
580009
India |
| Phone |
7760580737 |
| Fax |
|
| Email |
salima.bijapuri@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| SDM college of Medical Sciences and Hospital |
|
|
Primary Sponsor
|
| Name |
Sridevi C Hiremath |
| Address |
OPD number 13 Community Physiotherapy DEpartment
SDM College of Medical Health Sciences And Hospital Manjushree nagar Sattur Dharwad 580009
Karnataka |
| 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 Sridevi C Hiremath |
OPD number 13 Community Physiotherapy SDM Hospital Dharwad |
OPD number 13 Community Physiotherapy SDM College of Medical sciences and hospital manjushree nagar, Dharwad
Dharwad
KARNATAKA |
7892513306
shridevihmath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics Committee of SDM college of Medical Sciences and Hospita |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M058||Other rheumatoid arthritis with rheumatoid factor, (2) ICD-10 Condition: M058||Other rheumatoid arthritis with rheumatoid factor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
One group
Part 1: Standard education program
Part 2: Educational-behavioural JP program |
The educational content will cover an information talk by the rheumatologist regarding RA, drug treatments, diet and exercise. Principles of joint protection, pain control methods (heat and cold), relevant demonstrations, practice of exercise and relaxation will be addressed by the physiotherapist. Also there will be time for discussion and information leaflets will be provided.(Part1)
Subsequently, detailed demonstration and practice of hand joint protection methods, energy conservation techniques, videotaping of home tasks to identify problem activities and to find solution using the principles will be taught. Further repetition of principles and improved demonstration of hand joint method applied to making a cup of tea, and group practice of these activities with the opportunity to try assistive kitchen devices will be done. This joint protection program is based on health belief model and the theories of social learning and self-management. Participants will also be provided with and information pamphlet and workbook detailing the principles of JP.(Part 2)
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants who are diagnosed with RA by the rheumatologists and are experiencing hand pain on activity
2. Participants with wrist and metacarpophalangeal (MCP) joint pain and inflammation due to RA
3. Participants willing to attend the educational-behavioral joint protection program.
|
|
| ExclusionCriteria |
| Details |
1. Participants with severe comorbidities affecting joint function or the ability to participate and engage in the program such as advanced ischemic heart disease (IHD), uncontrolled diabetes, etc
2. Participants with significant cognitive impairment that may hinder their ability to understand and actively participate in the educational and behavioral components of the program
3. Participants who have undergone major joint surgery in the past year, as this could influence outcomes and adherence to the program
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The purpose of this study is to determine the effect of Educational- Behavioural hand joint protection intervention on pain, strength, and adherence to treatment in patients with rheumatoid arthritis.
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase the adherence & joint protection principles in people with RA |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
28/07/2025 |
| 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="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shridevihmath@gmail.com].
- For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
| Participants diagnosed with RA by rheumatology consultants will be recruited, including both inpatients and outpatients. Participants will be briefed about the research, and written consent will be obtained from those who are willing to participate. Intervention : All participants will be invited to attend an educational-behavioral joint protection program conducted once every week for a duration of 1.5–2 hours for 4 weeks. Program includes: The educational content will cover an information talk by the rheumatologist regarding RA, drug treatments, diet, and exercise. Principles of joint protection, pain control methods (heat and cold), relevant demonstrations, practice of exercise, and relaxation will be addressed by the physiotherapist. Also, there will be time for discussion, and information leaflets will be provided. (Part1) Subsequently, detailed demonstration and practice of hand joint protection methods, energy conservation techniques, and videotaping of home tasks to identify problem activities and find solutions using the principles will be taught. Further repetition of principles and improved demonstration of hand joint method applied to making a cup of tea, and group practice of these activities with the opportunity to try assistive kitchen devices will be done. This joint protection program is based on the health belief model and the theories of social learning and self-management. Participants will also be provided with an information pamphlet and workbook detailing the principles of JP. (Part 2) | Participants completing all 4 sessions will be included in the educational behavioural JP program, and participants attending 2 or less than 2 sessions will be included in the standard educational program. Participants in between these will not be considered as data for the study |