Pulse Shortwave Therapy in Cervical Osteoarthritis

August 29, 2019 updated by: BioElectronics Corporation

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Tripoli, Lebanon
        • New Mazloum Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 4 weeks

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)
Time Frame: 4 weeks

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
Time Frame: 4 weeks
Gastric Pain, Constipation/Diarrhea, Blood Pressure, Dizziness, Headache, Elevated Creatinine, Bronchospasm, LFT's, Edema/Fluid Retention.
4 weeks
Patient Satisfaction Rate
Time Frame: 4 weeks
Patient Satisfaction Rate will be determined a 5 point scale (0 -not at satisfied to 4 - completely satisfied)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioElectronics Corporation

Investigators

  • Principal Investigator: Rachid Mohammad, MD, New Mazloum Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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