Efficacy of a High Voltage Pulsed Current in the Non-Invasive Treatment of Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- Avazzia, Inc
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Motor Function Examination
研究概览
简要总结
A clinical study at Activated Family Chiropractic & Wellness, is being proposed to test the efficacy of a novel electrical stimulation platform named the Pro-Sport Ultra® designed by AVAZZIA to relieve pain and improve mobility in patients with Carpal Tunnel Syndrome (CTS).
详细描述
This study will recruit patients with a prior diagnosis (Dx) of CTS and have had a trial of conservative treatment for a minimum of 4 weeks without successful results due to continuing symptoms that interfere with normal function.
The primary objective of this study is to compare the changes obtained in CTS that have not successfully responded to non-surgical management by incorporating PRO-Sport Ultra® as opposed to an inactive device. This study aims to compare improvement obtained in CTS using the new therapy.
All participants will be randomized into two treatment groups and receive treatment with both active and inactive devices during the study. During the first 2 weeks, one group will receive treatment with the active device and the other group will receive treatment with the inactive device. At the end of week 3 (no treatment week), participants will return to the clinic and will be crossed over for the next 2 weeks of treatment.
The Avazzia PRO-Sport Ultra® and BEST-RSI® devices are non-invasive, hand-held, battery operated microcurrent devices that are FDA-cleared for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment in the management of post-surgical and post-traumatic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double (participant, care provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a prior diagnosis (Dx) of CTS and have had a trial of conservative treatment for a minimum of 4 weeks without successful results due to continuing symptoms that interfere with normal function.
- •Confirmation of this Dx shall include at least three findings as defined below:
- •Muscle atrophy, severe weakness of thenar muscles
- •2-point discrimination test >6mm
- •Flick sign (shaking hand)
- •Phalen's sign
- •Tinel's sign
- •Reverse Phalen's sign
- •Abnormal Katz hand diagram scores
- •Positive NCV testing
- •Age >18 - <70 years old
- •Males/Females of all ethnicities
- •Post-surgical failures >6 months post op
- •Ability to understand the informed consent document before signing it
排除标准
- •Systemic disease that would affect treatment outcome such as inflammatory joint diseases (i.e., rheumatoid arthritis, systemic lupus); malignancies undergoing treatment or any malignancies (in remission or not) with involvement of the musculoskeletal system.
- •Co-morbidities, thoracic outlet nerve impingement, neuropathy, etc. should be identified and, if significant, the candidate should be excluded from the study.
- •Cubital tunnel syndrome, anterior and posterior interosseous nerve syndrome, lateral and medial epicondylitis, handlebar palsy, De Quervain's disease, trigger finger, and Intersection syndrome should be differentiated from CTS and not included in this study.
- •Uncontrolled mood disorders, such as depression, anxiety.
- •Drug or substance abuse within past 90 days.
- •Any hand pathology requiring surgical intervention.
- •Active litigation, workers compensation
- •Any participant with an electrically implanted device such as a pacemaker, neural stimulator, etc.
- •Participant is currently pregnant, nursing, or may become pregnant.
结局指标
主要结局
Motor Function Examination
时间窗: 5 weeks
Change in the score of motor function examination during visit #1, 7, 8 ,14, and visit 15 \[Time Frame: baseline to 5 weeks\] Change will be assessed using the motor function score from 0 to 5 where 5 is full range of motion.
Nerve Conduction Velocity
时间窗: 5 weeks
Nerve conduction velocity during visit #1, 7, 8 ,14, and visit 15 \[Time Frame: baseline to 5 weeks\] Change in nerve conduction velocity will be assessed from the score obtained from testing done by the Mediracer Carpal Tunnel Syndrome Sensory exam from normal to severe.
Pain Level Assessment
时间窗: 5 weeks
Change in pain associated with CTS during visit #1, 7, 8 ,14, and visit 15 \[Time Frame: baseline to 5 weeks\] Pain will be assessed with VAS (Visual Analog Scale pain score) from 0 to 10 where 10 is the worst pain ever.
次要结局
- Dosage/Frequency of Analgesics changes(5 weeks)
- Healthy Related Quality of Life Changes(5 weeks)
- Sensory ability changes(5 weeks)