S-Asenosyl-L-Methionine vs Placebo for Osteoarthritis of the Hands

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to demonstrate the feasibility of evaluating SAMe tolerability, analgesic benefits, and daily functional improvement in patients with osteoarthritis of the hands compared to placebo. The secondary objective of this study is to generate preliminary data on discomfort, function, quality of life in patients with osteoarthritis of the hands when taking SAMe compared to placebo.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Criteria

Inclusion Criteria:

• Current primary care provider at Heater Road Primary Care

• Office visit at Heater Road clinic in the past 3 years

• Patient age 50-75 years

• 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