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Pulse Shortwave Therapy in Cervical Osteoarthritis

Primary Purpose

Cervical Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
ActiPatch
Etoricoxib 60 mg
Sponsored by
BioElectronics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Osteoarthritis

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • New Mazloum Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ActiPatch Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 16, 2018
Last Updated
August 29, 2019
Sponsor
BioElectronics Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03542955
Brief Title
Pulse Shortwave Therapy in Cervical Osteoarthritis
Official Title
The Efficacy/Safety Profile Of Pulsed Shortwave Therapy in Cervical Osteoarthritis: A Comparison Study Against Etoricoxib
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioElectronics Corporation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ActiPatch Group
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive an active pulsed shortwave therapy device to wear 24 hours a day for 4 weeks.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Subjects in this group will take Etoricoxib 60mg, once daily for 4 weeks.
Intervention Type
Device
Intervention Name(s)
ActiPatch
Other Intervention Name(s)
pulsed shortwave therapy
Intervention Description
A Pulsed Shortwave Therapy Device
Intervention Type
Drug
Intervention Name(s)
Etoricoxib 60 mg
Other Intervention Name(s)
analgesic
Intervention Description
nonsteroidal anti-inflammatory drug used as standard therapy
Primary Outcome Measure Information:
Title
Neck Disability Index (NDI)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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]
Time Frame
4 weeks
Title
Side Effects
Description
Gastric Pain, Constipation/Diarrhea, Blood Pressure, Dizziness, Headache, Elevated Creatinine, Bronchospasm, LFT's, Edema/Fluid Retention.
Time Frame
4 weeks
Title
Patient Satisfaction Rate
Description
Patient Satisfaction Rate will be determined a 5 point scale (0 -not at satisfied to 4 - completely satisfied)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachid Mohammad, MD
Organizational Affiliation
New Mazloum Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Omar Tabbouche, Pharm D
Organizational Affiliation
New Mazloum Hospital
Official's Role
Study Director
Facility Information:
Facility Name
New Mazloum Hospital
City
Tripoli
Country
Lebanon

12. IPD Sharing Statement

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Pulse Shortwave Therapy in Cervical Osteoarthritis

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