Knee Osteoarthritis Study: Ibuprofen and Dextrose Prolotherapy

This study is looking at how effective and safe it is to combine Ibuprofen (a common anti-inflammatory medicine) with dextrose prolotherapy (DPT) injections for treating knee osteoarthritis (OA). Researchers want to see if taking Ibuprofen around the time of DPT injections helps more than DPT injections with a placebo (an inactive substance). You might be able to join if you are between 45 and 75 years old, have knee OA, and are a DoD Healthcare beneficiary at DGMC. The study will measure changes in your knee pain and function using questionnaires over 12 weeks to see if the treatments are successful. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 68 participants. Participants will be divided into groups, with one group receiving Ibuprofen and DPT injections, and the other receiving a placebo and DPT injections.
What's involved
Participants will receive DPT injections every 3-5 weeks for a total of 3 times. On the day of each injection, they will take either Ibuprofen or a placebo for 7 days.
Compensation
Not stated in the trial record.
Follow-up
Your knee pain and function will be measured from enrollment until the end of treatment at 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06911359

The Effect and Safety of Anti-inflammatories and Dextrose Prolotherapy Injections in Treating Knee Osteoarthritis

Recruiting
PHASE2Ages 45–75InterventionalTreatment
David Grant U.S. Air Force Medical Center
~68 participants
Updated 2025-11-24 on ClinicalTrials.gov
What's tested:Participants are given Ibuprofen 400 mg to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times.Participants are given a placebo to take for 7 days on the day they receive a dextrose prolotherapy (DPT) injection. These procedures are repeated every 3-5 weeks for a total of 3 times.

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Knee Injury in Osteoarthritis (KOOS) questionnaire scores
Measured over From enrollment to the end of treatment at 12 weeks
+1 more outcome measured
Knee Osteoarthritis (OA)

NCT06911359

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • David Grant USAF Medical Center

    Travis AFB, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Alexander R Kim, MD · PRINCIPAL_INVESTIGATOR · David Grant USAF Medical Center

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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
  • Change in Knee Injury in Osteoarthritis (KOOS) questionnaire scoresFrom enrollment to the end of treatment at 12 weeks

    The KOOS questionnaire consist of a total of 23 items divided (unequally) among 5 subscales. The subscales include pain (5 items), symptoms (4 items), activities of daily living (ADL) (9 items), sport/recreation (3 items), and quality of life (QoL) (2 items). Each item is scored on a scale of 0-4. Zero is assigned to "never", "none," and "not at all" responses. Four is assigned to "always", "extreme," "totally," and "constantly" responses. Calculate mean scores for each subscale by adding the scores for each item (in the subscale) then dividing it by the total number of items (in the subscale). Then multiply the calculated mean scores (for each subscale) by 100, divide it by 4, then subtract it from 100. Total subscale scores range from 0 -100. 0 indicates extreme problems and 100 indicates no problems.

  • Change in Numeric Pain Rating Scale (NPRS) scoresFrom enrollment to the end of treatment at 12 weeks

    The NPRS is a 1-item questionnaire assessing pain severity using a number which describes the level of knee pain over the last 24 hours. Participants are to put an "X" on a linear scale from 0-10. Zero (0) is no pain and 10 is the worst possible pain.