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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-12-31

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.

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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active

Group wearing the active device emitting pulsed electromagnetic fileds

Group Type ACTIVE_COMPARATOR

Wearable pulsed electromagnetic fields

Intervention Type DEVICE

placebo

Group wearing the device non-emitting pulsed electromagnetic fileds

Group Type PLACEBO_COMPARATOR

Wearable pulsed electromagnetic fields

Intervention Type DEVICE

Interventions

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Wearable pulsed electromagnetic fields

Intervention Type DEVICE

Other Intervention Names

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actipatch

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No