Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis: Double Blinded, Randomized Clinical Trial

Not Applicable

Completed

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 McMaster Universities Osteoarthritis Index (WOMAC), in patients affected by osteoarthritis Secondary aim is the evaluate the effect on knee effusion reduction, when present and to evaluate pain intensity changes corrected by pain threshold measured by pressure algometry.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
active	Wearable pulsed electromagnetic fields	Group wearing the active device emitting pulsed electromagnetic fileds
placebo	Wearable pulsed electromagnetic fields	Group wearing the device non-emitting pulsed electromagnetic fileds

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4	baseline and 4 weeks	visual analogue scale (VAS) is a validated self report instrument assessing self report pain intensity Possible scores ranges:from 0 (no pain) to 100 (the maximum of pain)
Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4	baseline and 4 weeks	Multi-item questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items) and Physical Function (17 items). Score Range: On the Likert Scale version, the scores are summed for items in each subscale, with possible ranges as follows: pain=0-50, stiffness=0-20, physical function=0-170. A total WOMAC score is created by summing the items for all three subscales. A higher score represents a worse outcome.