Pulse Shortwave Therapy in Cervical Osteoarthritis

Study Overview
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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.

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

Conditions
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Cervical Osteoarthritis

Intervention / Treatment
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* Device: ActiPatch
* Drug: Etoricoxib 60 mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ActiPatch Group<br>Subjects in this group will receive an active pulsed shortwave therapy device to wear 24 hours a day for 4 weeks. | Device: ActiPatch<br>* A Pulsed Shortwave Therapy Device<br>* Other names: pulsed shortwave therapy;|
| Placebo Comparator: Control Group<br>Subjects in this group will take Etoricoxib 60mg, once daily for 4 weeks. | Drug: Etoricoxib 60 mg<br>* nonsteroidal anti-inflammatory drug used as standard therapy<br>* Other names: analgesic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

Secondary Outcome Measures

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