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

University of Messina

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Device: Wearable pulsed electromagnetic fields

Study type

Interventional

Funder types

Other

Identifiers

NCT01877278

11262 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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