Completed

NCT Number: NCT03542955

Pulse Shortwave Therapy in Cervical Osteoarthritis

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.

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Key information

Conditions

Cervical Osteoarthritis

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Mazloum Hospital

Tripoli, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ActiPatch

Device

A Pulsed Shortwave Therapy Device

Other names: pulsed shortwave therapy

Etoricoxib 60 mg

Drug

nonsteroidal anti-inflammatory drug used as standard therapy

Other names: analgesic

Primary outcomes

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.

Secondary outcomes

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]
Side Effects

Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

BioElectronics Corporation

Industry

Registry information

Official study title

The Efficacy/Safety Profile Of Pulsed Shortwave Therapy in Cervical Osteoarthritis: A Comparison Study Against Etoricoxib

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jun 1, 2018
Registry last updated: Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.