Pulse Shortwave Therapy in Cervical Osteoarthritis

NCT03542955 | Completed FDA Device

• 1 other identifier: PRO180402
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Visual Analog Scale (VAS)

  4 weeks

• Side Effects

  4 weeks

• Patient Satisfaction Rate

  4 weeks

Study Arms (2)

ActiPatch Group

ACTIVE COMPARATOR

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

Device: ActiPatch

Control Group

PLACEBO COMPARATOR

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

Drug: Etoricoxib 60 mg

Interventions

ActiPatch DEVICE

A Pulsed Shortwave Therapy Device

Also known as: pulsed shortwave therapy

ActiPatch Group

Etoricoxib 60 mg DRUG

nonsteroidal anti-inflammatory drug used as standard therapy

Also known as: analgesic

Control Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioElectronics Corporation: lead

Study Sites (1)

New Mazloum Hospital

Tripoli, Lebanon

Location

MeSH Terms

Interventions

Etoricoxib; Analgesics

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Rachid Mohammad, MD

  New Mazloum Hospital

  PRINCIPAL INVESTIGATOR

• Omar Tabbouche, Pharm D

  New Mazloum Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 1, 2018
• Study Start: May 1, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: August 30, 2019

Record last verified: 2018-05

Locations

LE (1)