Status:
RECRUITING
The Effect and Safety of Anti-inflammatories and Dextrose Prolotherapy Injections in Treating Knee Osteoarthritis
Lead Sponsor:
David Grant U.S. Air Force Medical Center
Conditions:
Knee Osteoarthritis (OA)
Eligibility:
All Genders
45-75 years
Phase:
PHASE2
Brief Summary
Our purpose is to expand upon the results of the pilot study performed at David Grant Medical Center (DGMC) which showed that concomitant non-steroidal NSAID use in adults with knee osteoarthritis (OA...
Eligibility Criteria
Inclusion
- Must be DoD Healthcare beneficiaries empaneled at DGMC
- Adults aged 45-75 years with a clinical diagnosis of Knee OA (either unilateral or bilateral) based on clinical and radiographic criteria as defined by the American College of Rheumatology (Altman 1987)
- Knee radiographs (within 2 years of start date) with Kellgren-Lawrence classification of 2-3
- Moderate to severe Knee pain for at least 3 months defined as a score of ≥4 using the NPRS (0-10) in response to the question "What is the average level of your left/ right knee pain in the past 3 months?"
- English speaking
- Not pregnant
- Not breastfeeding
- No allergy to dextrose, lidocaine, or sulfite
Exclusion
- Previous knee replacement surgery
- Previous meniscus repair/debridement surgery or chondral replacement surgery
- Any intra-articular injection including steroid, prolotherapy or platelet rich plasms within the previous 3 months
- Significant effusion as defined by a ballotable patella
- Pregnancy or breastfeeding
- Current/ongoing medical problems obtained from chart review contraindicating NSAID use to include chronic kidney disease stage II or higher, acute interstitial nephritis, coronary artery disease requiring percutaneous coronary intervention (PCI) or bypass surgery; Major Adverse Coronary Event (MACE), body mass index (BMI) ≥40, inflammatory arthropathy (gouty arthritis, psoriatic arthritis, or septic arthritis), history of GI bleed.
- Non-English speaking
- Allergy to dextrose, lidocaine, or sulfite
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06911359
Start Date
March 31 2025
End Date
December 31 2026
Last Update
November 24 2025
Active Locations (1)
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1
David Grant USAF Medical Center
Travis AFB, California, United States, 94535