68 Participants Needed

Anti-inflammatories + Dextrose Prolotherapy for Osteoarthritis

Recruiting at 1 trial location
CJ
AR
Overseen ByAlexander R Kim, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: David Grant U.S. Air Force Medical Center
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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, physical therapy, and surgery.The primary outcome is to determine the effect of concomitant oral ibuprofen vs. placebo use on intra-articular knee injections using hypertonic dextrose and the determine the short and long-term outcomes in each treatment group (ibuprofen, placebo) using the NPRS and KOOS questionnaires to assess pain and function.

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.

How is dextrose prolotherapy different from other treatments for osteoarthritis?

Dextrose prolotherapy is unique because it involves injecting a sugar solution (dextrose) into the affected area to stimulate tissue repair and regeneration, which may help improve joint function and reduce pain in osteoarthritis. Unlike other treatments that mainly focus on symptom relief, this method aims to address the underlying tissue damage.12345

What data supports the effectiveness of the treatment Dextrose Prolotherapy Injections, Ibuprofen for osteoarthritis?

Research shows that dextrose prolotherapy, which involves injecting a sugar solution, can help reduce pain and improve function in people with knee osteoarthritis. It aids in tissue repair and has shown promising results in improving symptoms without severe side effects.12567

Who Is on the Research Team?

AR

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

Must be DoD Healthcare beneficiaries empaneled at DGMC
Not pregnant
Not breastfeeding
See 5 more

Exclusion Criteria

Non-English speaking
Pregnancy or breastfeeding
Allergy to dextrose, lidocaine, or sulfite
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

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

12 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using NPRS and KOOS scores

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Dextrose Prolotherapy Injections
  • Ibuprofen
Trial Overview The trial tests if taking NSAIDs (like Ibuprofen) affects dextrose prolotherapy (DPT) injections' efficacy in treating knee osteoarthritis. It's a double-blinded study where participants are randomly assigned to receive either NSAIDs or a placebo alongside DPT injections.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Ibuprofen groupActive Control1 Intervention
Group II: Placebo groupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

David Grant U.S. Air Force Medical Center

Lead Sponsor

Trials
30
Recruited
2,300+

Citations

Comparative effectiveness of dextrose prolotherapy versus control injections and exercise in the management of osteoarthritis pain: a systematic review and meta-analysis. [2022]
Efficacy of Prolotherapy for Osteoarthritis: A Systematic Review. [2023]
Therapeutic effects of prolotherapy with intra-articular dextrose injection in patients with moderate knee osteoarthritis: a single-arm study with 6 months follow up. [2022]
A comparative analysis of prolotherapy efficacy in patients with knee osteoarthritis across varied dextrose concentrations. [2023]
Meta-analysis of clinical trials focusing on hypertonic dextrose prolotherapy (HDP) for knee osteoarthritis. [2022]
Dextrose prolotherapy in knee osteoarthritis: A systematic review and meta-analysis. [2022]
Hypertonic Dextrose Stimulates Chondrogenic Cells to Deposit Collagen and Proliferate. [2022]
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