The Efficacy/Safety Profile Of Pulsed Shortwave Therapy in Cervical Osteoarthritis: A Comparison Study Against Etoricoxib
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Neck Disability Index (NDI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Neck Pain of > 2 months
- •Cervical Osteoarthritis - Radiological Evidence
- •Males & females
- •Age: 30-60 years
排除标准
- •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)
- •Contra-indication to Etoricoxib 60 mg
- •Age <30 or >60 years
研究组 & 干预措施
ActiPatch Group
Subjects in this group will receive an active pulsed shortwave therapy device to wear 24 hours a day for 4 weeks.
干预措施: ActiPatch (Device)
Control Group
Subjects in this group will take Etoricoxib 60mg, once daily for 4 weeks.
干预措施: Etoricoxib 60 mg (Drug)
结局指标
主要结局
Neck Disability Index (NDI)
时间窗: 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.
次要结局
- Visual Analog Scale (VAS)(4 weeks)
- Side Effects(4 weeks)
- Patient Satisfaction Rate(4 weeks)