Actively Recruiting
The Effect of Non-steroidal Anti-inflammatory Drug (NSAID) Use on the Efficacy of Dextrose Prolotherapy in the Treatment of Knee Osteoarthritis: A Randomized Controlled Trial
Led by David Grant U.S. Air Force Medical Center · Updated on 2025-11-24
68
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect and safety of using non-steroidal anti-inflammatory drugs (NSAIDs) alongside dextrose prolotherapy (DPT) injections in adults with knee osteoarthritis (OA). This randomized, double-blinded, controlled trial involves men and women aged 45 to 75 with chronic knee OA, aiming to expand on earlier pilot study findings that suggested combining NSAIDs with DPT does not reduce treatment effectiveness and is safe. Participants will be randomly assigned to receive either ibuprofen or a placebo while undergoing three ultrasound-guided knee injections of 4 mL of 25% dextrose mixed with 1% lidocaine. These injections occur at baseline, week 4, and week 8, each accompanied by a 7-day supply of the assigned study drug. Participants are advised to avoid other pain medications and treatments during the study. During the 12-week study, participants will complete pain and function assessments using the Numeric Pain Rating Scale (NPRS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) at weeks 0, 4, 8, and 12. Researchers will monitor changes in these scores to determine the impact of ibuprofen versus placebo combined with DPT. Safety and treatment adherence will be closely followed throughout the trial period.
CONDITIONS
Brief Title
The Effect and Safety of Anti-inflammatories and Dextrose Prolotherapy Injections in Treating Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be DoD Healthcare beneficiaries empaneled at DGMC
- Adults aged 45 to 75 years with a clinical diagnosis of knee osteoarthritis in one or both knees
- Knee X-rays within 2 years showing Kellgren-Lawrence classification 2 or 3
- Moderate to severe knee pain for at least 3 months with a score of 4 or higher on the Numeric Pain Rating Scale
- English speaking
- Not pregnant or breastfeeding
- No allergy to dextrose, lidocaine, or sulfite
You will not qualify if you...
- Previous knee replacement surgery
- Previous meniscus repair, debridement, or chondral replacement surgery
- Any knee injection (steroid, prolotherapy, platelet-rich plasma) within the past 3 months
- Significant knee swelling defined by a ballotable patella
- Pregnancy or breastfeeding
- Medical conditions preventing NSAID use including chronic kidney disease stage II or higher, acute interstitial nephritis, coronary artery disease requiring intervention, major adverse coronary event, body mass index 40 or higher, inflammatory arthritis (gout, psoriatic, septic), or history of gastrointestinal bleeding
- Non-English speaking
- Allergy to dextrose, lidocaine, or sulfite
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 12 weeks
Participants receive dextrose prolotherapy injections combined with either Ibuprofen 400 mg or placebo taken for 7 days starting on the day of each injection. These injections and medication courses are repeated every 3 to 5 weeks for a total of three times.
3 injection visits with medication courses every 3 to 5 weeks
Trial Site Locations
Total: 1 location
1
David Grant USAF Medical Center
Travis AFB, California, United States, 94535
Actively Recruiting
Research Team
A
Alexander R Kim, MD
C
Carlton J Covey, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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