Clinical trial NCT06911359: The Effect and Safety of Anti-inflammatories and Dextrose Prolotherapy Injections in Treating Knee Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Knee Osteoarthritis (OA)
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2025-04-04
Enrollment: 68
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) undergoing a three-shot dextrose prolotherapy (DPT) injection series did not negate the efficacy of DPT. Additionally, it showed that giving both treatments simultaneously is safe and efficacious. The small sample size and design of the pilot study limited the conclusions that can be drawn on the concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) during DPT treatment.

This is a double-blinded, randomized, controlled trial that includes a subject population of males and females between the ages of 45-75 years who are DoD beneficiaries empaneled at DGMC with a history of chronic, symptomatic knee osteoarthritis in one or both knees, that meet study criteria.

Participants will have study inclusion/exclusion and knee films (within the past 2 years) reviewed by a study investigator to confirm eligibility to participate in the study. Eligible participants will be consented then randomized into treatment groups (ibuprofen, placebo) by the pharmacy. Participants will provide a baseline assessment of pain and dysfunction using the Numeric Pain Rating Scale (NPRS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaires. Participants will then have a series of three injections of 4mL of 25% dextrose mixed with 1% lidocaine into the knee under ultrasound guidance, performed at 0, 4 and 8 weeks (+/- 1 week) in addition to a 7-day supply of the study drug (ibuprofen, placebo) at these time points. NPRS and KOOS scores will be collected at 0, 4, 8 and 12 weeks. During the study period, participants will be counseled to avoid oral analgesics (other than what has been prescribed for them as part of the study) including NSAIDs, acetaminophen, or opioids, in addition to other procedures to treat their knee pain to include other injections, acupuncture, physical therapy, and surgery.

The primary outcome is to determine the effect of concomitant oral ibuprofen vs. placebo use on intra-articular knee injections using hypertonic dextrose and the determine the short and long-term outcomes in each treatment group (ibuprofen, placebo) using the NPRS and KOOS questionnaires to assess pain and function.


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

Primary outcomes:
measure: Change in Knee Injury in Osteoarthritis (KOOS) questionnaire scores
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Change in Numeric Pain Rating Scale (NPRS) scores
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Travis AFB
country: United States
facility: David Grant USAF Medical Center
state: California
Study officials:
affiliation: David Grant USAF Medical Center
name: Alexander R Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: