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

Study Overview
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Brief Summary
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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.

Official Title
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Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis Patients: a Double Blinded, Randomized Clinical Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Wearable pulsed electromagnetic fields


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active<br>Group wearing the active device emitting pulsed electromagnetic fileds | Device: Wearable pulsed electromagnetic fields<br> <br> * Other names: actipatch;|
| Placebo Comparator: placebo<br>Group wearing the device non-emitting pulsed electromagnetic fileds | Device: Wearable pulsed electromagnetic fields<br> <br> * Other names: actipatch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4 | 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) | baseline and 4 weeks | 
| Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4 | 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. | baseline and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Device, Osteoarthritis, Pulsed electromagnetic fields, Pain, Pressure algometry