Chronic Musculoskeletal Disease Clinical Trial
Official title:
Efficacy of "Pain Gear" in Patients With Chronic Musculoskeletal Pain
The current study was designed to evaluate the effectiveness and safety of the device in the common areas of the body affected by different causes of musculoskeletal pain in Vietnamese population in real life situation.
PainGear [ActiPatch®] (BioElectronics Corporation, MD, USA) has been recently introduced as
an 'topical' analgesic for localized musculoskeletal pain. PainGear is a noninvasive, low
power, easy to use, pulsed shortwave therapy device for localized musculoskeletal pain. The
device does not produce heat or any sensation. There are two basic requirements to use the
device, switching it on via an on/off switch, and affixing the device over the target area of
the body. The area of treatment is confined to the area within the 11.5-cm diameter loop
antenna covering an area of 100 cm2, the antennae is circular, soft and flexible and can be
shaped to fit the area/location being treated as required. The device can be used up to 24 h
per day and is placed over the area of localized pain either using medical tape or a
specifically designed wrap.
In a randomized, double-blind, placebo-controlled clinical trial, patients with radiographic
evidence of knee OA (osteoarthritis) and persistent pain higher than 40mm on the visual
analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in
60 knee OA patients. After 1 month, PainGear induced a significant reduction in VAS pain and
Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores compared with
placebo. Additionally, pain tolerance and physical health improved in PainGear -treated
patients. Twenty-six per cent of patients in the PainGear group stopped NSAID/analgesic
therapy. No adverse events were detected.
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