Anti-inflammatories + Dextrose Prolotherapy for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if using ibuprofen with dextrose prolotherapy (a type of injection treatment) is safe and effective for individuals with knee osteoarthritis, a joint condition causing pain and stiffness. The study will compare the effects of ibuprofen and a placebo on pain relief and knee function. It seeks participants who have experienced moderate to severe knee pain for at least three months and are Department of Defense healthcare beneficiaries. Participants will receive three dextrose prolotherapy injections and either ibuprofen or a placebo. The goal is to assess whether combining these treatments reduces pain and improves movement. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.
Will I have to stop taking my current medications?
During the study, you will need to avoid taking any oral pain relievers other than what is provided as part of the trial, such as ibuprofen or a placebo. This means you should not take other NSAIDs, acetaminophen, or opioids, and you should also avoid other treatments for knee pain like injections, acupuncture, physical therapy, or surgery.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found dextrose prolotherapy to be a safe treatment for knee osteoarthritis. Research shows it reduces stiffness and pain and improves overall function without major side effects. Reports indicate it is well-tolerated, with no serious adverse events noted during trials.
Ibuprofen, a common medication for managing pain and inflammation, is generally safe for most people when taken as directed, though some may experience mild side effects like an upset stomach or headaches.
Overall, previous research has shown both dextrose prolotherapy and ibuprofen to be safe. The current study aims to further explore their combined use and safety for knee osteoarthritis.12345Why are researchers excited about this trial's treatments?
Unlike the standard of care for osteoarthritis, which often includes NSAIDs like ibuprofen or corticosteroid injections, dextrose prolotherapy involves injecting a sugar solution directly into the affected joints. This treatment is unique because it aims to stimulate the body's natural healing processes, potentially leading to tissue repair and pain relief without relying on synthetic drugs. Researchers are excited about this approach because it could offer a long-lasting solution with fewer side effects compared to traditional anti-inflammatory medications. Additionally, the combination with anti-inflammatories might enhance the overall effectiveness, offering a new dual-action strategy for managing osteoarthritis pain.
What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?
Research has shown that dextrose prolotherapy injections can help treat knee osteoarthritis. Studies have found that these injections often improve pain and movement more effectively than traditional treatments. Patients in these studies reported lasting pain relief, better mobility, and less stiffness. Evidence suggests that using ultrasound to guide these injections can offer long-term benefits for people with knee osteoarthritis. Overall, dextrose prolotherapy appears promising for reducing symptoms and improving the quality of life for those with knee osteoarthritis.
In this trial, participants will receive either dextrose prolotherapy injections or ibuprofen, with a placebo group included for comparison.26789Who Is on the Research Team?
Alexander R Kim, MD
Principal Investigator
David Grant USAF Medical Center
Are You a Good Fit for This Trial?
This trial is for DoD beneficiaries aged 45-75 with chronic knee osteoarthritis, who can provide recent knee films to confirm eligibility. Participants must not use other oral analgesics or undergo treatments like acupuncture or surgery for their knee pain during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a series of three dextrose prolotherapy injections at 0, 4, and 8 weeks, along with a 7-day supply of ibuprofen or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment using NPRS and KOOS scores
What Are the Treatments Tested in This Trial?
Interventions
- Dextrose Prolotherapy Injections
- Ibuprofen
Find a Clinic Near You
Who Is Running the Clinical Trial?
David Grant U.S. Air Force Medical Center
Lead Sponsor