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

NCT07355712 | Completed DMC

• 2 other identifiers: KE/FK/1000/EC/2024s3 fkkmk ugm
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.How does this intervention affect the levels of IL-1β and MMP-3 in participants?

Conditions

Prolotherapy

Keywords

Knee Osteoarthritides; Prolotherapy; physical activity; interleukin-1beta; matrix Metalloproteinase 3

Outcome Measures

Primary Outcomes (1)

• Pain and Functional Capacity

  The primary outcome measure for this study is pain dan functional capacity using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) WOMAC Questionnaire consist of 3 subscales (pain, stiffness, and physical function). Pain subscale can be scored between 0-20 points, stiffness subscale can be scored between 0-8 points, and physical function subscales can be scored between 0-68 points. Those points can be interpreted better if its low and worser if it high in total (0-24 points for mild, 25-48 points for moderate, and 49-72 points for severe)

  6 week

Secondary Outcomes (3)

• Concentration of IL-1 Beta and MMP-3

  6 week

• Pain with Visual Analog Scale

  6 weeks

• Quality of Life with EQ-5D-5L

  6 weeks

Study Arms (2)

Prolotherapy + Personalized Physical Activity Program

EXPERIMENTAL

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)

Combination Product: Prolotherapy; Other: Personalized Physical Activity Program

Prolotherapy Only

ACTIVE COMPARATOR

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

Procedure: Prolotherapy Only

Interventions

Prolotherapy Only PROCEDURE

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

Prolotherapy Only

Prolotherapy COMBINATION_PRODUCT

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

Prolotherapy + Personalized Physical Activity Program

Personalized Physical Activity Program OTHER

A physical therapy program 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)

Prolotherapy + Personalized Physical Activity Program

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gadjah Mada University: lead
• Faculty of Medicine, Gadjah Mada University: collaborator
• Universitas Islam Indonesia: collaborator

Study Sites (1)

fkkmk UGM

Sleman, Special Region of Yogyakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Prolotherapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• muhammad yusuf hisam MYH Hisam, MD

  Gadjah Mada University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants receive the same intervention (prolotherapy combined with physical activity or prolotherapy alone) within the study

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: January 21, 2026
• Study Start: July 10, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 21, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)