Status:
COMPLETED
Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis: Double Blinded, Randomized Clinical Trial
Lead Sponsor:
University of Messina
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The aim of the study is to evaluate the efficacy of a wearable device using pulse electromagnetic fields on pain intensity reduction, measured by visual analogue score (VAS) and Western Ontario and Mc...
Eligibility Criteria
Inclusion
- a diagnosis of primary OA of the knee according to the ACR criteria, including radiologic evidence of OA
- age \>40 years
- symptomatic disease for at least 6 months prior to enrollment
- persistent pain despite receiving the maximum tolerated doses of conventional medical therapy, including acetaminophen (4 gm/day) and/or a nonsteroidal antiinflammatory drug (NSAID), with persistent pain defined as a minimum mean score of 25 mm on the visual analog scales (VAS) for global pain (0-100-mm range for each) daily pain during the month prior to study enrollment
- ability to attend followup appointments
Exclusion
- secondary causes of OA
- local or systemic infection
- diabetes mellitus
- systemic arthritis
- allergy to anesthetic agent or contrast material
- coagulopathy
- anticoagulant therapy
- had previous IA steroid injection
- avascular necrosis of bone
- patients who are on specific OA pharmacological therapy (NSAIDS, opioids) for more than 2 weeks prior enrollment
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01877278
Start Date
June 1 2013
End Date
December 1 2014
Last Update
February 9 2015
Active Locations (1)
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1
Reumatologia, Dipartimento di medicina clinica e sperimentale, Università degli studi di Messina, AOU G. Martino
Messina, Messina, Italy, 98100