NCT03542955

Pulse Shortwave Therapy in Cervical Osteoarthritis

The Efficacy/Safety Profile Of Pulsed Shortwave Therapy in Cervical Osteoarthritis: A Comparison Study Against Etoricoxib

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: BioElectronics Corporation · Industry
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The ActiPatch is an FDA cleared pain therapy device that uses pulsed shortwaves to interrupt pain signals at the nerve. 200 patients will be randomized and divided into an ActiPatch treatment group and comparison analgesic drug therapy group . Subjects will be assessed with the Neck Disability Index (NDI) at baseline and at four weeks and VAS scores will be recorded in order to determine the efficacy of the ActiPatch device compared to Etoricoxib. Cervical osteoarthritis causes chronic neck pain which could potentially be alleviated by the ActiPatch without the use of medication.

Detailed description

Cervical Osteoarthritis causes chronic pain in the neck due to the discs of the spine breaking down, losing fluid, and becoming stiffer over time. As obesity and age increase, the likelihood of cervical osteoarthritis increases as well. When the pain caused by the broken down discs becomes severe, it may result in a loss of mobility in the neck region. Chronic neck pain has a serious impact on not only quality of life, but can also negatively affect a persons ability to lead a healthy active lifestyle. Standard analgesic therapy it limited in efficacy and can result in serious adverse effects specially with long term use.

Conditions

• Cervical Osteoarthritis

Interventions

Type	Name	Description
DEVICE	ActiPatch	A Pulsed Shortwave Therapy Device
DRUG	Etoricoxib 60 mg	nonsteroidal anti-inflammatory drug used as standard therapy

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-07-30
• Completion: 2019-07-30
• First posted: 2018-06-01
• Last updated: 2019-08-30

Locations

1 site across 1 country: Lebanon

Regulatory

• FDA-regulated device study