Combined Effect of Prolotherapy and Personalized Physical Activity on Knee Osteoarthritis Progres… (NCT07355712) | Clinical Trial Compass
CompletedNot Applicable
Combined Effect of Prolotherapy and Personalized Physical Activity on Knee Osteoarthritis Progression
Indonesia74 participantsStarted 2024-07-10
Plain-language 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.
Who can participate
Age range
19 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.