CTRI

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CTRI Number

CTRI/2024/03/064262 [Registered on: 18/03/2024] Trial Registered Prospectively

Last Modified On:

15/03/2024

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

The impact of comorbidities on pain and physical activity in patients with knee pain

Scientific Title of Study

The impact of comorbidities on pain and physical activity in patients with osteoarthritis knee

Trial Acronym

nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	AP NITHARSHINI
Designation	MPT ORTHOPAEDICS AND TRAUMATOLOGY
Affiliation	Sri Ramachandra Institute Of Higher Education And Research
Address	Sri Ramachandra Institute Of Higher Education And Research Faculty of Physiotherapy No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu. Sri Ramachandra Institute Of Higher Education And Research Faculty of physiotherapy No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu. Chennai TAMIL NADU 600116 India
Phone	9176604183
Fax
Email	nitharshini.ap@gmail.com

Details of Contact Person
Scientific Query

Name	MRS ANGELINE R
Designation	ASSISTANT PROFESSOR
Affiliation	SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
Address	Sri Ramachandra Institute Of Higher Education And Research Faculty of physiotherapy No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu. Sri Ramachandra Institute Of Higher Education And Research Faculty of physiotherapy No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu. Chennai TAMIL NADU 600116 India
Phone	9943529400
Fax
Email	angelinejobin75@gmail.com

Details of Contact Person
Public Query

Name	AP NITHARSHINI
Designation	MPT ORTHOPAEDICS AND TRAUMATOLOGY
Affiliation	SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
Address	Sri Ramachandra Institute Of Higher Education And Research Faculty of physiotherapy No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu. Sri Ramachandra Institute Of Higher Education And Research Faculty of physiotherapy No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu. Chennai TAMIL NADU 600116 India
Phone	9176604183
Fax
Email	nitharshini.ap@gmail.com

Source of Monetary or Material Support

SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH

Primary Sponsor

Name	Sri Ramachandra Institute of Higher Education and Research
Address	sri ramachandra institute of higher education and research Faculty of physiotherapy No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu.
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
A P NITHARSHINI	Sri Ramachandra Institute Of Higher Education And Research	Faculty of physiotherapy OPD (ground floor) No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India. Chennai TAMIL NADU	9176604183 nitharshini.ap@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
ETHICAL COMMITTEE FOR STUDENTS PROJECTS DHR/ICMR RESGISTRATION NO:EC/NEW/INST/2023/TN/0321	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M170\|\|Bilateral primary osteoarthritis of knee,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	40.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	40-60 years of both genders with symptomatic and radiological verified unilateral and bilateral Osteoarthritis knee Patients with comorbidities (respiratory, CVD, depression, type 2 diabetes, obesity, hypertension). Patients who have sufficient cognition and communication skills to understand the nature of study.

ExclusionCriteria

Details

Joint infections
Patients with other knee injuries
Patients waiting for joint replacement surgeries
Recent surgeries

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
GPAQ(Global physical activity questionnaire).	baseline

Secondary Outcome

Outcome	TimePoints
Numerical Rating Scale (NRS)	4 weeks

Target Sample Size

Total Sample Size="111"
Sample Size from India="111"
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)

25/03/2024

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

Individuals of knee OA patients of both genders, an age between 40 to 60 years of age. The individuals were selected based on the inclusion and exclusion criteria among patients with OA knee with comorbidities. PA level will be measured by the Global physical activity questionnaire (GPAQ). Pain will be measure by numerical pain rating scale (NPRS) to assess physical activity and pain in knee OA patients. comorbidities will be categorized into five groups: Respiratory (asthma, bronchitis, COPD), CVD (angina, heart failure, stroke, heart attack), depression, type 2 diabetes and obesity.