Trial studying safety and effects 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 Ibuprofen 400 mg?
This is an investigational study of taking ibuprofen alongside dextrose prolotherapy injections for knee osteoarthritis. Ibuprofen is designed to reduce pain and inflammation by blocking certain enzymes in the body.
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
- This study checks if taking ibuprofen along with knee injections is safe and effective for knee arthritis.
- Who it's for
- Men and women aged 45 to 75 with chronic knee arthritis who are enrolled in the Department of Defense health system.
- What's involved
- Participants receive three knee injections and take either ibuprofen or a placebo pill for 12 weeks.
- Time commitment
- The study lasts 12 weeks and requires visits at the start, 4 weeks, 8 weeks, and 12 weeks.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Travis AFB, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.