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Pulsed Shortwave Therapy (ActiPatch®) Study in Chronic Low Back Pain

NCT03828864 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2019-02-05

No results posted yet for this study

Summary

This study aims to test the efficacy of the ActiPatch® device by means of a randomized double blind controlled trial in a convenience sample of chronic low back pain patients at RPAH pain clinic. Outcome measures are validated psychometric measures evaluating known determinants of pain related disability, functional capacity measures, and pain scores; and a bespoke questionnaire assessing fidelity with recommended usage, and willingness to reduce analgesic or other pain related medications with the future assistance of the ActiPatch®.

Conditions

  • Chronic Low Back Pain

Interventions

DEVICE

Pulsed Shortwave Therapy

Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day

DEVICE

Placebo Pulsed Shortwave Therapy

Placebo Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day

Sponsors & Collaborators

  • Royal Prince Alfred Hospital, Sydney, Australia

    collaborator OTHER

  • BioElectronics Corporation

    lead INDUSTRY

Principal Investigators

  • Graeme Campbell · Royal Prince Alfred Hospital, Sydney, Australia

  • Arun Aggarwal, Professor · Royal Prince Alfred Hospital, Sydney, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2020-02-01
Completion
2020-05-01
FDA Device
Yes

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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 NCT03828864 on ClinicalTrials.gov