Pulse Shortwave Therapy in Cervical Osteoarthritis

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Osteoarthritis
• Intervention / Treatment: Device: ActiPatch; Drug: Etoricoxib 60 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Tripoli, Lebanon
    • New Mazloum Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: ActiPatch Group; Subjects in this group will receive an active pulsed shortwave therapy device to wear 24 hours a day for 4 weeks.	Device: ActiPatch; A Pulsed Shortwave Therapy Device; Other Names: pulsed shortwave therapy
PLACEBO_COMPARATOR: Control Group; Subjects in this group will take Etoricoxib 60mg, once daily for 4 weeks.	Drug: Etoricoxib 60 mg; nonsteroidal anti-inflammatory drug used as standard therapy; Other Names: analgesic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability Index (NDI)	It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Al the points can be summed to a total score. The test can be interpretated as a raw score, with a maximum score of 50, or as a percentage. A higher score indicates more patient-rated disability.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme. There could be variation in verbal descriptor anchors depending on intended use of the scale. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale]	4 weeks
Side Effects	Gastric Pain, Constipation/Diarrhea, Blood Pressure, Dizziness, Headache, Elevated Creatinine, Bronchospasm, LFT's, Edema/Fluid Retention.	4 weeks
Patient Satisfaction Rate	Patient Satisfaction Rate will be determined a 5 point scale (0 -not at satisfied to 4 - completely satisfied)	4 weeks

Collaborators and Investigators

• Sponsor: BioElectronics Corporation
• Investigators: Principal Investigator: Rachid Mohammad, MD, New Mazloum Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ACTUAL): July 30, 2019
• Study Completion (ACTUAL): July 30, 2019

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (ACTUAL): June 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylitis; Osteoarthritis; Spondylarthritis; Spondylosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Analgesics; Etoricoxib
• Other Study ID Numbers: PRO180402

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes