Noxipoint Therapy vs. Standard Physical Therapy Using Electrical Stimulation for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory (BPI) Severity of the Pain at Its Worst
研究概览
简要总结
The purpose of this study is to validate the efficacy of Noxipoint(TM) therapy on chronic pain, and compare it with standard physical therapy using electrical stimulation on patients with chronic pain.
Invented by Dr. Charlie Koo at Stanford University, Noxipoint Therapy is a specific procedure with precise location, duration and intensity of TENS stimulation within the general FDA guidelines. The therapy substantially relieves general muscular/tendon pain and persistently restores the muscle and tendon function. The surface locations of nociceptors at the free nerve ending (i.e., "Noxipoints") are focused on in the stimulation therapy. Multiple clinical uses of Noxipoint Therapy confirmed the consistent efficacy of such stimulation at Noxipoints. An observational study of Noxipoint therapy within the FDA-approved use of TENS demonstrated an encouraging 93% success rate in eliminating the chronic pain, such as frozen shoulder pain, within 2-3 sessions. It is an order-of-magnitude improvement over the non-specific application of TENS and any other modalities in pain treatment. A unique neuro-immuno-signaling pathway that implicates the activation of adult stem cells, such as satellite cells in muscles, is implicated based on such a high success rate.
详细描述
View http://paincurecenter.com/Clinical\_Outcome.html for the observational study mentioned in the Brief Summary above. For more detailed cases, please view http://paincurecenter.com/uploads/Nocipoint\_therapy\_clinical\_study\_w\_o\_ID\_2011-2012.pdf
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-64 years old male or female
- •Having chronic pain (ICD-9: 338.21, 338.29) in the neck/upper back (ICD-9: 723.1), or the shoulder (ICD-9: 719.41)
- •Pain duration over 6 months, with at least one month of history of other therapy treatments (Physical therapy, steroid injection, acupuncture, analgesic medicine, and/or massage therapy)
排除标准
- •Patients with BPI Severity at its Worst below 5
- •Traumatic injury from external impact force
- •Pain caused by traumatic bone fractures
- •History of traumatic cervical injury
- •History of osteoporosis
- •Pain related to systemic inflammatory conditions including polymyalgia rheumatic, systemic lupus erythematosis
- •Signs of psychosomatic illness
- •Severe rheumatoid arthritis undergoing active treatment including DMARD biologics
- •Steroid injection on pain site within 4 weeks
- •Language and/or cognitive inability to complete the assessment questionnaires
- •Previous TENS for pain relief
- •For safety reasons, patients wearing cardiac pace makers, implanted defibrillator, or pregnant women
研究组 & 干预措施
Physical Therapy
干预措施: Physical Therapy (Procedure)
Noxipoint Therapy
干预措施: Noxipoint Therapy (Procedure)
结局指标
主要结局
Brief Pain Inventory (BPI) Severity of the Pain at Its Worst
时间窗: One year
BPI will be evaluated as the score change from the baseline. As a supplemental measure, the baseline of individual patients will also be normalized to 100%, with the change being a percentile of the baseline.
次要结局
- Shoulder Pain and Disability Index (SPADI)(One year)
- Neck Disability Index (NDI)(One year)
- BPI Interference of Function(One year)
- Range of motion(One year)
- BPI Severity of the pain in the other three occasions(One year)