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

Gadjah Mada University

Status: Completed

Conditions: Prolotherapy

Treatments: Other: Personalized Physical Activity Program; Combination Product: Prolotherapy; Procedure: Prolotherapy Only

Study type: Interventional

Funder types: Other

Identifiers

NCT07355712

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KE/FK/1000/EC/2024

Details and patient eligibility

About

The aim of this clinical trial is to assess whether prolotherapy combined with personal physical activity is effective in managing pain (measured using the VAS and WOMAC scales) and improving the quality of life in participants with Grade 2 Knee Osteoarthritis (OA).

This trial will also measure the levels of IL-1β and MMP-3 in the participants. The primary research questions are:

1. Does prolotherapy combined with personal physical activity reduce pain levels and improve clinical outcomes in participants with knee OA compared to those receiving prolotherapy ?
2. How does this intervention affect the levels of IL-1β and MMP-3 in participants?

Researchers will compare prolotherapy combined with personal physical activity to prolotherapy alone to determine its impact on clinical outcomes and changes in biomarkers in patients with knee OA.

Full description

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

Enrollment: 74 patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Prolotherapy + Personalized Physical Activity Program

Experimental group

Description:

This arm will be using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine and physical therapy starting 2 day post-injection with guidance of trained professionals and exercise educational videos supplementation (10 repetitions per session, 3 sessions per day, 3 days per week)

Treatment:

Combination Product: Prolotherapy

Other: Personalized Physical Activity Program

Prolotherapy Only

Active Comparator group

Description:

This arm will be using prolotherapy with 20 mL of 15% hypertonic dextrose solutions and 2 mL of 2% lidocaine

Treatment:

Procedure: Prolotherapy Only