Title: Efficacy of Local Intra-articular Platelet Rich Plasma (PRP) Injection versus Steroids for Knee Rheumatoid Arthritis (RA) – A Single blind Randomized control Trial.

Background: Rheumatoid Arthritis (RA) in the knee is a debilitating manifestation of systemic autoimmune disease, causing inflammation, pain, and functional impairment. This study aims to compare the effectiveness of local intra-articular Platelet Rich Plasma (PRP) injections and steroids in managing knee RA-related inflammation, pain, and quality of life.

Objective: To evaluate and compare the outcomes of local intra-articular PRP injection and intra-articular steroids in terms of pain alleviation, reduction in joint inflammation, disease activity, and improvement in quality of life in patients with knee RA.

Methodology:

Study Design: This will be a single-blind randomized controlled trial.

Study Setting: The study will take place in the Outpatient Department (OPD) of the Department of Orthopaedics at AIIMS Kalyani.

Participants: Patients aged ≥18 years fulfilling the 2010 ACR-EULAR classification criteria for RA and having low disease activity will be included.

Sample Size: The calculated sample size is 26 participants in each group, considering a 20% dropout rate.

Intervention Groups:

Group 1 (PRP): Participants will receive three doses of local intra-articular PRP injection of 5ml each prepared from autologous venous blood, administered one month apart.

Group 2 (Steroids): Participants will receive a single dose of intra-articular triamcinolone 40mg mixed with 3ml of 2 percent Lignocaine.

Outcome Measures: Participants will be assessed at baseline, 3 months, and 6 months after intervention. Outcome measures include:

Visual Analog Scale (VAS) for pain assessment.

Health Assessment Questionnaire-Disability Index (HAQ-DI) for functional status.

Swelling score and tenderness score for joint inflammation.

Ultrasound findings for joint assessment.

Data Analysis: Data will be entered into Microsoft Excel and analyzed using SPSS v25.0 and Dxt v1.0 software. Continuous variables will be expressed as means with standard deviations, and categorical data will be presented as proportions. Statistical significance will be set at P < 0.05. Intention-to-treat analysis will be performed, and additional statistical tests will be carried out if necessary.

Significance: This study addresses the need for effective local management of knee RA symptoms, focusing on pain reduction and inflammation control. By comparing PRP injections and steroids, we aim to contribute insights into improved therapeutic options for enhancing the quality of life and well-being of individuals with knee RA.

Conclusion: By conducting a rigorous randomized controlled trial, we hope to shed light on the potential benefits of local intra-articular PRP injection as an innovative therapeutic approach for knee RA. The findings could influence clinical practice and offer patients a more effective and well-tolerated treatment option.