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:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT05363020
Eligibility Criteria:
Inclusion Criteria:
* Current primary care provider within the Dartmouth Health system
* Office visit at Dartmouth Health in the past 3 years
* Participants must be 40 or older at the time of signing the informed consent
* Participants have discomfort or functional limitations of one or both hands AND either:
1. Objective findings of at least one hand meeting diagnostic criteria based on the American College of Rheumatology (ACR)\* or
2. Existing radiographic evidence of osteoarthritis as judged by a radiologist
* Patients taking OTC or prescription analgesics who are willing to stop their current analgesics for two weeks prior to study entry and remain off those medications over the course of the study
* \*Objective inclusion criteria (see poster schematic)
Swelling or deformity of 2 of the following ten joints: the 2nd and 3rd distal interphalangeal (DIP) of each hand, the 2nd and 3rd proximal interphalangeal (PIP) of each hand, and the 1st carpometacarpal joints of both hands.
Exclusion Criteria:
* Patients taking prescription medications other than NSAIDs for their OA who are unable to stop their medication
* Patients with diagnoses of arthritis from conditions other than OA
* Patients whose symptomatic joint is an artificial joint
* Patients with Bipolar Disorder
* Patients taking any of the following medications at study entry OR starting any of these medications during the study period:
1. daily opioids (including tramadol or buprenorphine)
2. gabapentin or pregabalin
3. prednisone
4. Prescription NSAIDs that they are unable to stop or topical diclofenac
5. SNRI drugs (Effexor, Cymbalta, Fetzima, Pristiq)
* The participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05363020
Study Brief:
Protocol Section:
NCT05363020