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

NCT02974023 | Withdrawn DMC

• 1 other identifier: PE/PAINGEAR/09/2016
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Musculoskeletal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To record change in frequency of other analgesic modalities utilization

  2 weeks period

• To assess difference in Pain-related disability, indexed by the Oswestry Disability Index (ODI)

  2 weeks, recorded on 1st and 14th day

• To assess patients satisfaction with two weeks therapy of PainGear

  14th day

Interventions

Pain Gear DEVICE

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.

Also known as: ActiPatch

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from Low back pain and arthritis.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PharmEvo Pvt Ltd: lead
• BioElectronics Corporation: collaborator

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 28, 2016
• Study Start: June 30, 2017
• Primary Completion: October 30, 2017
• Study Completion: December 1, 2017
• Last Updated: October 3, 2018

Record last verified: 2016-12