Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The Boston CTS Questionnaire symptom severity scale and functional assessment.
研究概览
简要总结
We hypothesize that a standard course of INF can result in significant improvement in CTS as measured by clinical, electrodiagnostic, or ultrasound measures.
详细描述
INF is a novel non-invasive therapy based on the principle of restoring vascular function at the capillary level in peripheral nerve. his therapy has been shown to improve clinical function in patients with diabetic-associated polyneuropathy, a model for various forms of ischemic neuropathy. CTS is a common condition where regional compression at the wrist results in ischemic focal demyelination of the distal median nerve. This results in sensory dysfunction, pain, and eventually axon loss and weakness if the compression is sufficiently severe and prolonged. Standard therapy for CTS includes wrist splints, regional lidocaine injections, ergonomic adjustments, various forms of occupation therapy, and ultimately surgical release of the carpal tunnel ligament. However, all of these are either temporary in their effect or invasive. The diagnosis of CTS relies on clinical, electrodiagnostic or NCS, and ultrasound methods.
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients referred to the LLUH Neurology Electrodiagnostic Laboratory with electrodiagnostic and clinical evidence of CTS (uni- or bilateral)
- •Ages >18 and < 75 (irrespective of gender)
- •Current use of splints as long as the frequency of treatment is unaltered and onset of use is > 1 week in duration
排除标准
- •Prior carpal tunnel release > 2 years ago
- •The presence of any condition that would prevent NCS from accurately diagnosing CTS (e.g., hereditary polyneuropathy or acquired demyelinating polyneuropathy)
- •Workman's Compensation cases
- •Undergoing conservative or surgical/injection therapy (physical or occupational therapy, injections)
- •Clinically silent CTS in face of positive electrodiagnostic results
- •Sufficiently severe clinical symptoms that warrant more aggressive therapy i.e., carpal injections or release
- •Any confounding medical condition that the investigator deems may adversely affect subject participation or outcomes
研究组 & 干预措施
Intraneural facilitation therapy
The intraneural facilitation intervention is a novel manual physical therapy approach with anecdotal evidence in neuropathic pain symptoms through biasing blood flow from an artery through the nutrient vessels into the epineurium of an accompanying nerve. The main concept of intraneural facilitation is the use of two manual holds. The first hold is called facilitation hold and includes putting the contralateral joint in a maximal loose-pack position that is comfortable to the patient. The hypothesis with this initial hold is the nerve will have greater excursion the accompanying artery and the nutrient vessels that are clustered at the joint will be stretched. This stretch may enlarge the opening at the junction of the artery and bridging nutrient vessel, therefore consistently creating a vascular bias into the neural epineurial capillaries. Theoretically, this creates increased epifascicular vascular pressure which may be absent due to epineurial ischemia.
干预措施: Intraneural facilitation (INF) (Other)
Sham therapy
Will be performed by a different therapist than actual INF. The patient will be asked to do the following combination of passive range of motion (PROM) and active ROM activities to promote blood flow in the affected arm Each visit will last about 45 minutes, twice a week for 6 weeks (total 12 sessions).
Missing > 4 sessions will invalidate subject outcomes.
干预措施: Sham INF (Other)
结局指标
主要结局
The Boston CTS Questionnaire symptom severity scale and functional assessment.
时间窗: change between week 1 and 3 months after completion of INF therapy
composite measurement of carpal tunnel symptomology (pain and numbness) and functional assessment
次要结局
- Visual analog scale (VAS)(change between week 1 and 3 months after completion of INF therapy)
- Ultrasound(change between baseline and one week after completion of INF therapy)
研究者
Bryan Tsao
Neurology Chairman
Loma Linda University