Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT06911359
Eligibility Criteria:
Inclusion 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
Exclusion Criteria:
* 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 coronary intervention (PCI) or bypass surgery; Major Adverse Coronary Event (MACE), body mass index (BMI) ≥40, inflammatory arthropathy (gouty arthritis, psoriatic arthritis, or septic arthritis), history of GI bleed.
* Non-English speaking
* Allergy to dextrose, lidocaine, or sulfite
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT06911359
Study Brief:
Protocol Section:
NCT06911359