Cervical Osteoarthritis Clinical Trial
Official title:
The Efficacy/Safety Profile Of Pulsed Shortwave Therapy in Cervical Osteoarthritis: A Comparison Study Against Etoricoxib
| NCT number | NCT03542955 |
| Other study ID # | PRO180402 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 1, 2018 |
| Est. completion date | July 30, 2019 |
| Verified date | May 2018 |
| Source | BioElectronics Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 180 |
| Est. completion date | July 30, 2019 |
| Est. primary completion date | July 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 60 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Lebanon | New Mazloum Hospital | Tripoli |
| Lead Sponsor | Collaborator |
|---|---|
| BioElectronics Corporation |
Lebanon,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | Side Effects | Gastric Pain, Constipation/Diarrhea, Blood Pressure, Dizziness, Headache, Elevated Creatinine, Bronchospasm, LFT's, Edema/Fluid Retention. | 4 weeks | |
| Secondary | Patient Satisfaction Rate | Patient Satisfaction Rate will be determined a 5 point scale (0 -not at satisfied to 4 - completely satisfied) | 4 weeks |