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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Musculoskeletal Disease
• Intervention / Treatment: Device: Pain Gear

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from Low back pain and arthritis.

Description

Inclusion Criteria:

• Chronic musculoskeletal pain of more than 6 month duration
• Participant is willing and able to give informed consent for participation in the trial.
• In the Investigator's opinion, is able and willing to comply with all trial requirements.
• Male or female ages 18-80 years old
• A current VAS pain rating ≥5/10
• Able to complete and tolerate treatment for the study period.

Exclusion Criteria:

• Pregnant Woman
• Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, spinal stimulators or other implanted electronic devices.
• Patients using personal home based electrical stimulation devices
• Active psychiatric disorders (as evidenced by use of antipsychotic or medication).
• Patients diagnosed with history of significant mood disorder will be excluded (depression or anxiety with adequate control would be acceptable).
• Scheduled elective surgery or other procedures requiring general anesthesia during the trial.
• Participant with life expectancy of less than 6 months, or inappropriate for placebo medication.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Participants who are not able to understand verbal or written English, and for whom adequate translation/interpretation cannot be readily obtained

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess difference in subjective pain with the use of PainGear for 2 weeks.	[ Time Frame: Change from baseline visual analogue score over the course of 2 weeks]	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To record change in frequency of other analgesic modalities utilization	[ Time Frame: Change from baseline analgesic modalities usage over the course of 2 weeks period, to be recorded in modalities chart]	2 weeks period
To assess difference in Pain-related disability, indexed by the Oswestry Disability Index (ODI)	[ Time Frame: Change from baseline ODI score at 2 weeks, recorded on 1st and 14th day ]	2 weeks, recorded on 1st and 14th day
To assess patients satisfaction with two weeks therapy of PainGear	[Time Frame: 14th day]	14th day

Collaborators and Investigators

• Sponsor: PharmEvo Pvt Ltd
• Collaborators: BioElectronics Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): October 30, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimate): November 28, 2016

Study Record Updates

• Last Update Posted (Actual): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Muscular Diseases; Musculoskeletal Pain; Musculoskeletal Diseases
• Other Study ID Numbers: PE/PAINGEAR/09/2016