Platelet-Rich Plasma and the Effects of NSAIDs on Pain and Functional Scores in Knee Osteoarthritis
WithdrawnPhase 1, Phase 2NCT05742763
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The primary research purpose is to determine if the use of a drug therapy intervention (each study participant will be randomly assigned to receive one of 3 study medications which will be blinded from everyone, including the study participants, and all research staff (except the principal investigator), combined with a series of 3 injections of Platelet-Rich Plasma (PRP) into an osteoarthritic knee joint, leads to reductions in knee pain, and improvements in physical function. Improvements will be assessed by serially evaluating pain scores and functionality using standardized and validated questionaires which will be completed by the study participant at each clinic office visit. In addition, blood tests will be drawn at each visit to evalute any changes in blood compostion. If the participant meets the study inclusion and exclusion criteria and agrees to attend 7 follow up office visits, they will be eligble to enroll in the study. If they wish to volunarily enroll in the study, it will be explained in detail, afterwhich all questions and any concerns will be answered. Each office visit will take between 30-45 minutes and will take place over a 12-month study period comittment.
Study details
- Official title
- Platelet-Rich Plasma and the Effects of NSAIDs on Pain and Functional Scores in Knee Osteoarthritis
- Conditions
- Osteoarthritis of the Knee
- Degenerative Osteoarthritis
- Knee Pain Chronic
- Interventions
- Combination product: Ibuprofen and PRP
- Combination product: Acetaminophen and PRP
- Combination product: Placebo and PRP
- Sponsor
- QC Kinetix LLC
- Start date
- 2023-11-01
- Primary completion
- 2024-10-07
- Sex
- All
- Age range
- from 50 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Age \>50 (all genders, and all races) 2. Unilateral Symptoms 3. Symptomatic knee pain on most days in the past month 4. OA diagnosed with radiographic imaging (K-L grade 2 or 3) 5. Can commit to 8 office visits (initial and 7 follow up) over a 12-month period 6. Able to understand written/spoken English - all study participants will be provided with an overview of the study goals, research activities and tasks, and an opportunity to address any questions, comments, or concerns about their participation in the PRP\_NSAIDs-PRP research trial. After which, written informed consent and HIPPA Research Disclosure form will be obtained. Exclusion Criteria: 1. K-L grade 1 (indicting questionable disease) or grade 4 (indicating severe disease) 2. Have lateral joint space narrowing greater than or equal to medial joint space narrowing on x-ray using the Osteoarthritis Research Society International (OARSI) atlas 3. Had injection into the target knee joint of glucocorticoid in the past 3 months or hyaluronic acid in the past 6 months 4. Had any autologous blood product or stem cell preparation in the past 5. Had knee surgery on their target knee within the past 12 months 6. Have systemic or inflammatory joint disease such as rheumatoid arthritis 7. Have a history of crystalline or neuropathic arthropathy 8. Had a knee joint replacement or high tibial osteotomy on their target knee 9. Plan to have knee surgery in the target knee in next 12 months 10. Have other muscular, joint, or neurological condition affecting lower limb function 11. Osteonecrosis, avascular necrosis 12. Gastrointestinal reflux disease or peptic ulcer disease 13. NSAID intolerance 14. Renal dysfunction or liver disease 15. Previous gastric bypass surgery 16. Have a needle phobia 17. Have immunosuppression or acute infective processes 18. Have cancer or other tumors in the last 3 years, or undergone any treatment for cancer or tumors in the last 3 years 19. Have a bleeding disorder or are receiving anticoagulation therapy 20. Have the presence of a warm, tense joint effusion 21. Have a platelet count \< 150,000/μL 22. Have any other medical condition precluding participation in the study 23. Pregnancy 24. Are unwilling to discontinue any use of an NSAID, acetaminophen, and other analgesic usage, from 1 month before the baseline assessment until the last follow-up assessment at month 12 25. Have a body mass index (BMI) \> 40 kg/m2 26. Have a weight ≤ 100 pounds 27. Unable to at…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05742763