Using anti-inflammatories and dextrose injections to treat knee osteoarthritis

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

This study is testing whether combining anti-inflammatory medication with dextrose injections can help adults aged 45-75 with knee osteoarthritis feel less pain.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 45 Years to 75 Years
• Sex: All
• Sponsor: David Grant U.S. Air Force Medical Center (Federal)
• Locations: 1 site (Travis AFB, California)
• Trial ID: NCT06911359 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of combining non-steroidal anti-inflammatory drugs (NSAIDs) with dextrose prolotherapy (DPT) injections in adults suffering from knee osteoarthritis. Participants aged 45-75 will receive either ibuprofen or a placebo alongside DPT injections over a series of three treatments. The study is designed as a double-blinded, randomized, controlled trial to ensure unbiased results. The goal is to determine if NSAIDs can be safely used without compromising the efficacy of DPT in alleviating knee pain.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45-75 with chronic knee osteoarthritis who are beneficiaries of the Department of Defense and meet specific clinical criteria.

Not a fit: Patients who have had knee replacement surgery or recent intra-articular injections may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new, effective treatment option for patients with knee osteoarthritis, potentially improving their quality of life.

How similar studies have performed: Previous pilot studies have shown promising results for the combined use of NSAIDs and DPT, indicating potential for success in this larger trial.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Travis AFB, California

• David Grant USAF Medical Center — Travis AFB, California, United States (Recruiting)

Study contacts

• Principal investigator: Alexander R Kim, MD — David Grant USAF Medical Center
• Study coordinator: Alexander R Kim, MD

Conditions Knee Osteoarthritis