Pulse Shortwave Therapy in Cervical Osteoarthritis

BioElectronics Corporation

Status: Completed

Conditions: Cervical Osteoarthritis

Treatments: Device: ActiPatch; Drug: Etoricoxib 60 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03542955

PRO180402

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic Neck Pain of > 2 months
• Cervical Osteoarthritis - Radiological Evidence
• Males & females
• Age: 30-60 years

Exclusion criteria

• Neck Pain <2 months
• Pregnancy
• Irreversible neck injury
• Congenital Neurological/Muscular Diseases
• Osteo-articular Disorders
• Auto-immune Diseases
• Osteoporosis
• Hematological Diseases (Thalassemia/Sickle Cell Anemia)
• Cancer
• Contra-indication to Etoricoxib 60 mg
• Age <30 or >60 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups, including a placebo group

ActiPatch Group

Active Comparator group

Description:

Subjects in this group will receive an active pulsed shortwave therapy device to wear 24 hours a day for 4 weeks.

Treatment:

Device: ActiPatch

Control Group

Placebo Comparator group

Description:

Subjects in this group will take Etoricoxib 60mg, once daily for 4 weeks.

Treatment:

Drug: Etoricoxib 60 mg