4-Aminopyridine to Delay Carpal Tunnel Release or Resolve Carpal Tunnel Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- Results of symptomatic improvement in the Michigan Hand Outcomes Questionnaire (MHQ)
研究概览
简要总结
The investigators have found recent promising data supporting the use of a currently FDA approved drug, 4-aminopyridine, in the treatment of nerve injury including compression neuropathy. The purpose of this research is determine whether 4-aminopyridine can treat carpal tunnel syndrome or delay the need for formal surgical release in patients with known carpal tunnel syndrome who would otherwise undergo surgery.
详细描述
Carpal tunnel syndrome affects somewhere between 3 and 10% of the Unites States population. Symptoms associated with this disorder include numbness and tingling in the radial three digits of the hand. These symptoms often cause sleeplessness. They have been attributed to work related activities. The diagnosis of carpal tunnel syndrome is made clinically. Several confirmatory tests exist in the setting of carpal tunnel syndrome. In the United States the gold standard diagnostic for carpal tunnel syndrome is electrodiagnostic evaluation. This notwithstanding, recent literature suggests that other diagnostic methods including ultrasound evaluation of the median nerve at the carpal tunnel as well as clinical diagnostic criteria are sufficient to adequately and specifically diagnose carpal tunnel syndrome.
Several treatments exist for carpal tunnel syndrome. Treatment range from non-operative braces or positional movements. Moving on to intervention treatments there are several injections that have been used to treat carpal tunnel syndrome. Carpal Tunnel Syndrome is most definitively and completely treated by surgical release of the median nerve at the carpal tunnel. Surgical releases themselves have been performed under a variety of techniques from formal median nerve exploration to mini-open release as well endoscopic release. Resolution of symptoms after carpal tunnel release has been regarded as the gold standard to which other treatments can be compared.
Several registries of compression neuropathy patients have been compiled. These registries reveal that non-invasive assessment with standardize validated questionnaires can be used to measure the progression of symptomology, and the resolution of treatment. Given the history and wealth of experience in the diagnosis and treatment in this condition, it's natural to ask are there non-operative pharmacological treatments that may delay or remove the need for carpal tunnel release surgery. Certainly, the comparison to surgical decompression as the gold standard is desirable.
More research is needed to evaluate the role of 4-aminopyridine (4AP) in the treatment of compression neuropathy. The investigational treatment will be used to test the hypothesis that 4AP improves symptoms and electrodiagnostic parameters in carpal tunnel syndrome patients.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with non-traumatic carpal tunnel syndrome without any other confounding diagnosis (e.g. cubital tunnel syndrome, cervical nerve compression)
- •Standard of care EDX testing within 6 months of study enrollment
- •Cognitive ability to report sensory and motor deficit during examination.
- •Able to complete twice daily dosing of 4-AP for the entire 6 week treatment period.
- •Adults subject aged 18-90
- •Ability to give written informed consent.
- •Capable of safely undergoing electrodiagnostic testing (EDX).
- •Availability for all study visits.
排除标准
- •Inability to complete twice daily dosing during 6 week treatment period.
- •History of multiple sclerosis, stroke or any other diagnosed neurological disorder
- •History of hypersensitivity to AMPYRA® or 4-aminopyridine
- •Current use of aminopyridine medications, including other compounded 4-AP
- •Suspected renal impairment based on the Choyke questionnaire.
研究组 & 干预措施
4-aminopyridine
Study drug: dalfampridine (generic) 10mg ER capsule
干预措施: 4-Aminopyridine (Drug)
Placebo
Placebo-1 capsule
干预措施: Placebo (Other)
结局指标
主要结局
Results of symptomatic improvement in the Michigan Hand Outcomes Questionnaire (MHQ)
时间窗: Baseline (prior to study treatment) to 56 weeks post treatment.
Improvement of Carpal Tunnel Syndrome symptoms will be measured with standardized validated outcomes measure, the Michigan Hand Outcomes Questionnaire (MHQ) for improvement in carpal tunnel symptomatology. The MHQ is a tool used to assess patients with hand disorders through the measurement of 6 health domains: overall hand function, activities of daily living, pain, work performance, aesthetics, and patient satisfaction. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance. Baseline measures will be completed prior to treatment and repeated at each study visit with the final outcome questionnaire completed at the final, 56 week visit.
Results of symptomatic improvement in the Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
时间窗: Baseline (prior to study treatment) to 56 weeks post treatment
Improvement of Carpal Tunnel Syndrome symptoms will be measured using the Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ) - a validated patient reported outcome measure. The scale contains 6 items on the severity and frequency of night and daytime numbness, tingling and pain. Each item is scored on a 5-point Likert scale from 1 (no symptoms) to 5 (most severe symptoms). Subjects will complete a baseline questionnaire prior to treatment initiation. The questionnaire will be completed all study visit following initiation of treatment until the final study visit at 56 weeks post treatment.
次要结局
- Electrodiagnostic improvement following treatment(Baseline (prior to study treatment) and 8 weeks post treatment.)
研究者
John Elfar
Tenured Professor, Chairman, Department of Orthopaedic Surgery
University of Arizona