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Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain

NCT03240146 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-08-02

No results posted yet for this study

Summary

The ActiPatch is a cutaneous device which is CE marked approved for relief of pain and has FDA clearance as an over the counter device for the adjunctive treatment of osteoarthritis of the knee and plantar fasciitis. It is taped over the affected area and stimulation at a high frequency is reported to alleviate pain with no sensation. By randomising patients between application of an active device or a dummy device and assessment of disability and pain scores at four weeks the efficacy or otherwise can be established. Chronic low back pain is a major health problem and if effective this has major economic implications as the device is cheap and safe.

Conditions

  • Chronic Low Back Pain

Interventions

DEVICE

Pulsed Shortwave Therapy

Pulsed Shortwave Therapy device

Sponsors & Collaborators

  • BioElectronics Corporation

    lead INDUSTRY

Principal Investigators

  • Chandra Koneru, MD · North Alabama Primary Care

  • Sree Koneru, Ph.D · BioElectronics Corporation

  • Ian Rawe, Ph.D. · BioElectronics Corporation

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2017-12-21
Completion
2017-12-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03240146 on ClinicalTrials.gov