Combined Effect of Prolotherapy and Personalized Physical Activity on Knee Osteoarthritis Progression

The objective of this clinical trial is to evaluate the levels of IL-1β and MMP-3, clinical outcomes related to pain (measured using the Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)), as well as the quality of life in participants with knee osteoarthritis (OA) who are treated with pain management through prolotherapy combined with personalized physical activity. This trial aims to develop a complementary therapy or an alternative treatment option that is cost-effective, accessible, and potentially more affordable for the broader population.

Study Design/Methods:

This study will utilize a Randomized Controlled Trial (RCT) design with pre- and post-test assessments.

Group/Arm :

• Experimental Group (Prolotherapy and Personalized Physical Activity Program)
• Active Comparator/Control (Prolotherapy only)

Intervention :

• Experimental Group: using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine and physical therapy starting 2 days post-injection with guidance of trained professionals and exercise educational videos (10 repetitions per session, 3 sessions per day, 3 days per week)
• Active Comparator Group: using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine

Measurement :

• The primary outcome will be a clinical assessment measured using theWOMAC questionnaire and VAS
• The secondary outcome will be biomarker data of IL-1 Beta and MMP-3 measured with ELISA using kits from ABclonal, IL-1Beta (Cat. No. RK00001, Lot No. 9680034260724) and MMP-3 (Cat. No. RK00308, Lot No. 9680000230724).

Data Analysis Plan:

The data will be analyzed using the Kappa Test, Univariate Analysis, and Bivariate Analysis (Independent T-Test, Paired T-Test, Wilcoxon Test, Chi-Square, Spearman and Pearson Correlation Tests, and ANCOVA).

Anticipated Outcomes:

• Low risk of allergies
• Reduction in pain levels in participants
• Improvement in functional outcomes of participants

Risk and Benefit:

Risks:

• Possible side effects or complications, such as allergic reactions or infections, may occur during the study.

Benefits:

• This study seeks to identify a new and effective alternative therapy and complementary treatment that is more affordable and widely accessible. It is expected to provide significant pain relief, functional improvements, and enhanced quality of life for patients suffering from knee osteoarthritis

Inclusion criteria

• Adults ≥18 years with primary knee osteoarthritis (OA) diagnosed by ultrasonography who provided written informed consent.
• Participants were required to be cooperative and capable of complying with the study protocol

Exclusion criteria

• A history of traumatic knee arthritis
• Knee OA associated with trauma, fracture, ankylosing spondylitis, or septic arthritis
• Major comorbidities significantly impairing quality of life (e.g., cancer, heart failure, renal failure, stroke)
• Use of NSAIDs or systemic steroids within 1 week
• Intra-articular corticosteroid injection within 2 months; or current use of injectable or hormonal contraception.