Genicular Artery Embolization for Osteoarthritis
(SHAM-PAIN Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that patients should not have had a corticosteroid injection in the affected knee within 3 months before joining the trial and should not be using long-acting corticosteroids within 6 months (or short-acting within 3 months).
What data supports the effectiveness of the treatment Genicular Artery Embolization for Osteoarthritis?
Is genicular artery embolization safe for treating knee osteoarthritis?
How is the treatment Genicular Artery Embolization different from other treatments for knee osteoarthritis?
Genicular Artery Embolization (GAE) is a unique treatment for knee osteoarthritis that involves blocking blood flow to certain arteries in the knee to reduce pain and inflammation, unlike traditional treatments that often rely on medications or surgery. This minimally invasive procedure is particularly considered for patients with persistent pain who do not respond well to other therapies.23467
What is the purpose of this trial?
Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.
Research Team
Osman Ahmed, MD
Principal Investigator
University of Chicago Department of Radiology
Eligibility Criteria
This trial is for individuals with severe knee osteoarthritis pain that hasn't improved with regular medical treatments. Participants should be willing to undergo a procedure and follow-up assessments. Specific eligibility details are not provided, so interested individuals should inquire further.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo Genicular Artery Embolization (GAE) or a sham procedure to assess pain reduction in knee osteoarthritis
Follow-up
Participants are monitored for changes in pain and analgesic use at multiple time points post-intervention
Treatment Details
Interventions
- Genicular Artery Embolization
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator