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

NCT07355712 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-01-21

No results posted yet for this study

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. 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.

Conditions

  • Prolotherapy

Interventions

PROCEDURE

Prolotherapy Only

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

COMBINATION_PRODUCT

Prolotherapy

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

OTHER

Personalized Physical Activity Program

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)

Sponsors & Collaborators

  • Faculty of Medicine, Gadjah Mada University

    collaborator UNKNOWN

  • Universitas Islam Indonesia

    collaborator OTHER

  • Gadjah Mada University

    lead OTHER

Principal Investigators

  • muhammad yusuf hisam MYH Hisam, MD · Gadjah Mada University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2025-10-01
Completion
2025-10-01

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07355712 on ClinicalTrials.gov