CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/02/080108 [Registered on: 07/02/2025] Trial Registered Prospectively

Last Modified On:

15/05/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Relationship of thoughts about pain with pain overthinking, functional disability, and pain intensity in rheumatoid arthritis patients.

Scientific Title of Study

Relationship of Metacognitions with Pain Catastrophising, Disability and Pain Intensity in Patients 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	Lakshmi Jain
Designation	Masters Student
Affiliation	Manipal College of Health Professions
Address	Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore, Karnataka Bangalore KARNATAKA 560017 India
Phone	9560526546
Fax
Email	lakshmi.mhsblr2023@learner.manipal.edu

Details of Contact Person
Scientific Query

Name	Jeeshma Vijin
Designation	Assistant Professor
Affiliation	Manipal College of Health Professions
Address	Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of higher Education, Bangalore, Karnataka Bangalore KARNATAKA 560017 India
Phone	8217723817
Fax
Email	jeeshmaclipsy@gmail.com

Details of Contact Person
Public Query

Name	Jeeshma Vijin
Designation	Assistant Professor
Affiliation	Manipal College of Health Professions
Address	Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of higher Education, Bangalore, Karnataka Bangalore KARNATAKA 560017 India
Phone	8217723817
Fax
Email	jeeshmaclipsy@gmail.com

Source of Monetary or Material Support

No.98, Rustam Bagh Road, Old Airport Road, Department of Clinical Psychology, Manipal College of Health Professions,Manipal Academy of Higher Education, Bangalore 560017

Primary Sponsor

Name	Manipal Academy of Higher Education
Address	No.98, Rustam Bagh Road, Old Airport Road, Department of Clinical Psychology, Manipal College of Health Professions,Manipal Academy of Higher Education, Bangalore 560017
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
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
Lakshmi Jain	Manipal Hospitals	Department of Rheumatology, Outpatient Service, -1 floor, Manipal Hospital #98, HAL Old Airport Road, 560017 Bangalore KARNATAKA Bangalore KARNATAKA	9560526546 lakshmi.mhsblr2023@learner.manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Ethics Committee of Manipal Hospitals Bangalore	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M059\|\|Rheumatoid arthritis with rheumatoid factor, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. All patients (both males and females) diagnosed with Rheumatoid Arthritis. 2. Lying between 18-65 years of age. 3. Fulfilling ACR criteria for Rheumatoid Arthritis.

ExclusionCriteria

Details

1. Patients below 18 years of age and over 65 years of age.
2. Individuals with neurological diseases, failure of the liver and kidneys, pregnancy, major psychiatric diseases and severe chronic obstructive pulmonary disease

Method of Generating Random Sequence

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome	TimePoints
Pain Metacognitions Questionnaire	At baseline (0 days)

Secondary Outcome

Outcome	TimePoints
Pain Catastrophising Scale	At baseline (0 days)
Health Assessment Questionnaire- Disability Index	At baseline (0 days)
Visual Analogue Scale	At baseline (0 days)

Target Sample Size

Total Sample Size="384"
Sample Size from India="384"
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="400"

Phase of Trial

N/A

Date of First Enrollment (India)

28/02/2025

Date of Study Completion (India)

15/05/2025

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

15/05/2025

Estimated Duration of Trial

Years="0"
Months="6"
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

There is evident research on the role of metacognitions in patients with fibromyalgia, chronic pain, chronic fatigue syndrome, muscle dystrophy and certain psychological disorders such as schizophrenia, depression, OCD, PTSD and GAD. Systematic reviews have revealed a strong relationship between metacognitions, pain catastrophising and severity of pain in patients with chronic musculoskeletal pain, emphasising its consideration in preliminary assessments. However, there is no known evidence of studies on the relationship of metacognitions with pain catastrophising, disability and pain intensity in patients with rheumatoid arthritis. It is also not known if duration of disease, geographical factors and medication consumption play a role and thus need to be studied further. Thus, the specific influences of metacognitions on pain catastrophising, disability and pain intensity in patients with Rheumatoid arthritis need to be studied. There is also no evident study that has been conducted on the Indian population, which needs to be considered as different cultural attitudes play a role towards pain, illness and rehabilitation.