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Tests treatment safety and results for Knee Osteoarthritis (OA)
Official title The Effect and Safety of Anti-inflammatories and Dextrose Prolotherapy Injections in Treating Knee Osteoarthritis
ClinicalTrials.gov ID: NCT06911359
What this study is testing
What is 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 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 an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for knee osteoarthritis (oa).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75
You may be able to join if
- 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...
- 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...
- English speaking
You likely can't join if
- 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...
See the full eligibility 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
- 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...
- Non-English speaking
- Allergy to dextrose, lidocaine, or sulfite
The study team makes the final eligibility decision.
Where it's taking place
- Travis AFB, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Travis AFB, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.