NCT03240146

Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain

Pulsed Shortwave Therapy (PSWT) Treatment for Chronic Musculoskeletal Low Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: BioElectronics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Chronic low back pain is a major public heath challenge for a number of reasons including prevalence, seriousness, vulnerable populations, the utility of population health strategies, and the importance of prevention at both the population and individual levels. Its incidence and prevalence are increasing with an aging population and the rise in obesity. When considering the location of chronic pain and its aetiology, back pain was the most common location with arthritis/osteoarthritis being the most common cause. Chronic low back back pain is costly to nations-not just in terms of health care expenditures and disability compensation but also in terms of lost school days, lost productivity and employment, reduced incomes, and lost potential and quality of life.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DEVICE	Pulsed Shortwave Therapy	Pulsed Shortwave Therapy device

Timeline

• Start date: 2017-09-28
• Primary completion: 2017-12-21
• Completion: 2017-12-21
• First posted: 2017-08-04
• Last updated: 2018-08-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study