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Pulse Shortwave Therapy in Cervical Osteoarthritis

NCT ID: NCT03542955

Last Updated: 2019-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-07-30

Brief Summary

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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

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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.

Conditions

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Cervical Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ActiPatch Group

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

Group Type ACTIVE_COMPARATOR

ActiPatch

Intervention Type DEVICE

A Pulsed Shortwave Therapy Device

Control Group

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

Group Type PLACEBO_COMPARATOR

Etoricoxib 60 mg

Intervention Type DRUG

nonsteroidal anti-inflammatory drug used as standard therapy

Interventions

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ActiPatch

A Pulsed Shortwave Therapy Device

Intervention Type DEVICE

Etoricoxib 60 mg

nonsteroidal anti-inflammatory drug used as standard therapy

Intervention Type DRUG

Other Intervention Names

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pulsed shortwave therapy analgesic

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioElectronics Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachid Mohammad, MD

Role: PRINCIPAL_INVESTIGATOR

New Mazloum Hospital

Omar Tabbouche, Pharm D

Role: STUDY_DIRECTOR

New Mazloum Hospital

Locations

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New Mazloum Hospital

Tripoli, , Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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PRO180402

Identifier Type: -

Identifier Source: org_study_id