The effect of collagen-containing supplementation on pain, quality of life and functional parameters in osteoarthritis patients

Not Applicable

Conditions: Knee osteoarthritis.
Unilateral primary osteoarthritis, unspecified knee
M17.10

Registration Number: IRCT20240411061470N1

Lead Sponsor: Ondokuz Mayis University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 40

Inclusion Criteria

Diagnosed with unilateral or bilateral Kellgren and Lawrence radiographic grade 2 or 3 knee OA for more than 3 months
Non-vegetarian
Willing to participate in all scheduled visits and tests

Exclusion Criteria

Kellgren and Lawrence diagnosed with radiographic grade 1 or 4 knee OA
Any history of trauma, fracture or surgery on the index joint
Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases or malignancies within the last 5 years
History of hypersensitivity to the rescue medication or any of the products used in the study
Active viral or bacterial infection according to clinical examination
Expected knee arthroscopy or arthroplasty or life-threatening pathology
Received intra-articular injections or corticosteroids in the target knee joint (the most painful knee at screening) within the last 6 months
Patients with intolerance to protein-based foods or supplements, pregnant or breastfeeding women and those with alcohol dependence

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Assessment. Timepoint: Pre-intervention and after 8 weeks of intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthrtis Index (WOMAC), Visual Analogue Scale (VAS).;Quality of Life Assessment. Timepoint: Pre-intervention and after 8 weeks of intervention. Method of measurement: Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Oxford Knee Score (OKS), Tampa Scale for Kinesiophobia (TSK), Short Form Health Survey (SF-12), Foot Function Index (FFI).;Balance Assessment. Timepoint: Pre-intervention and after 8 weeks of intervention. Method of measurement: Berg Balance Scale (BBS).;Functional Performance Assessment. Timepoint: Pre-intervention and after 8 weeks of intervention. Method of measurement: Timed Up and Go (TUG), 6-Minute Walking Test (6MWT), The Five Repetition Sit to Stand Test (5STS), Stair-Climbing Test (SCT).

Secondary Outcome Measures