Cervical Osteoarthritis
Conditions
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.
Interventions
DEVICEActiPatch
A Pulsed Shortwave Therapy Device
DRUGEtoricoxib 60 mg
nonsteroidal anti-inflammatory drug used as standard therapy
Sponsors
BioElectronics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Rate | 4 weeks | Patient Satisfaction Rate will be determined a 5 point scale (0 -not at satisfied to 4 - completely satisfied) |
| 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 \[on 100-mm scale\] |
| Side Effects | 4 weeks | Gastric Pain, Constipation/Diarrhea, Blood Pressure, Dizziness, Headache, Elevated Creatinine, Bronchospasm, LFT's, Edema/Fluid Retention. |
Countries
Lebanon
Outcome results
None listed