Pulse Shortwave Therapy in Cervical Osteoarthritis

• Sponsor: BioElectronics Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03542955
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 12

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Osteoarthritis	Device: ActiPatch; Drug: Etoricoxib 60 mg	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Efficacy/Safety Profile Of Pulsed Shortwave Therapy in Cervical Osteoarthritis: A Comparison Study Against Etoricoxib
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: Jul 30, 2019
• Actual Study Completion Date: Jul 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Neck Disability Index (NDI) [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.

Secondary Outcome Measures

1. Visual Analog Scale (VAS) [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]

2. Side Effects [4 weeks]

   Gastric Pain, Constipation/Diarrhea, Blood Pressure, Dizziness, Headache, Elevated Creatinine, Bronchospasm, LFT's, Edema/Fluid Retention.

3. Patient Satisfaction Rate [4 weeks]

   Patient Satisfaction Rate will be determined a 5 point scale (0 -not at satisfied to 4 - completely satisfied)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Mazloum Hospital	Tripoli		Lebanon

Sponsors and Collaborators

• BioElectronics Corporation

Investigators

• Principal Investigator: Rachid Mohammad, MD, New Mazloum Hospital
• Study Director: Omar Tabbouche, Pharm D, New Mazloum Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BioElectronics Corporation
• ClinicalTrials.gov Identifier: NCT03542955
• Other Study ID Numbers: PRO180402
• First Posted: Jun 1, 2018
• Last Update Posted: Aug 30, 2019
• Last Verified: May 1, 2018

• 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
• Additional relevant MeSH terms: Osteoarthritis; Spondylarthritis; Spondylosis; Etoricoxib; Analgesics

Study Results

No Results Posted as of Aug 30, 2019