NCT03828864

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

Pulsed Shortwave Therapy (PSWT) Chronic Low Back Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: BioElectronics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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®.

Detailed description

This study aims to test the efficacy of the ActiPatch® device by means of a randomised double blind controlled trial in a convenience sample of chronic low back pain patients at Royal Prince Alfred Hospital (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

Type	Name	Description
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

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-02-01
• Completion: 2020-05-01
• First posted: 2019-02-04
• Last updated: 2019-02-05

Regulatory

• FDA-regulated device study