NCT02974023

Efficacy of "Pain Gear" in Patients With Chronic Musculoskeletal Pain

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: PharmEvo Pvt Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Musculoskeletal Disease

Interventions

Type	Name	Description
DEVICE	Pain Gear	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 musculo¬skeletal pain.

Timeline

• Start date: 2017-06-30
• Primary completion: 2017-10-30
• Completion: 2017-12-01
• First posted: 2016-11-28
• Last updated: 2018-10-03