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NCT06911359 · ClinicalTrials.gov registry record · Phase 2
The Effect and Safety of Anti-inflammatories and Dextrose Prolotherapy Injections in Treating Knee Osteoarthritis
A Phase 2 study of Knee Osteoarthritis (OA), sponsored by David Grant U.S. Air Force Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT06911359 is a Phase 2 study of Knee Osteoarthritis (OA) that is actively recruiting participants, run by David Grant U.S. Air Force Medical Center. The registered enrollment target is 68 participants, below the 150-participant average among 3 other Knee Osteoarthritis (OA) trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06911359, a Phase 2 study of Knee Osteoarthritis (OA), is actively recruiting participants, sponsored by David Grant U.S. Air Force Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study 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, ph
Conditions Studied
Interventions
- DRUG 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.
- DRUG 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.
Study Locations (1)
California
- David Grant USAF Medical Center - Travis AFB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2025-03-31 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06911359
The ClinicalTrials.gov registry entry for NCT06911359 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 150-participant average among 3 other Knee Osteoarthritis (OA) trials with a reported enrollment target (55% lower). The listed sponsor is David Grant U.S. Air Force Medical Center, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Knee Osteoarthritis (OA) appearing as the primary indexed condition, and to 2 interventions - of which 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. is the first listed.
NCT06911359 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06911359 about?
NCT06911359 is a clinical study titled "The Effect and Safety of Anti-inflammatories and Dextrose Prolotherapy Injections in Treating Knee Osteoarthritis". 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 o...
What is the current status of trial NCT06911359?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2025-03-31. Estimated completion is 2026-12-31.
What conditions does trial NCT06911359 study?
This clinical trial studies the following conditions: Knee Osteoarthritis (OA).
What interventions are being tested in trial NCT06911359?
The interventions under investigation include: 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. (DRUG), 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. (DRUG).
Who is sponsoring clinical trial NCT06911359?
This trial is sponsored by David Grant U.S. Air Force Medical Center, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06911359 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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