PRP as Adjuvant Treatment to CTR for Severe CTS Tunnel Syndrome
2022年4月18日 更新者：Michael Fredericson, MD
Utilizing Platelet-Rich Plasma as an Adjuvant to Carpal Tunnel Release for Severe Carpal Tunnel Syndrome
This study assesses the potential benefit of adjuvant platelet-rich plasma (PRP) with carpal tunnel release (CTR) for patients with severe carpal tunnel syndrome (CTS).
CTR is a rather common procedure performed and seems to be quite effective for those with moderate CTS, but a number of patients with severe CTS do not have quite the same response post-CTR.
The investigators will recruit patients who fall into the severe CTS category and compare CTR with and without adjuvant PRP to see if PRP can improve outcomes of this common surgery.
研究概览
地位
招聘中
详细说明
- Study team recruits patients with severe CTS who meet inclusion and exclusion criteria in an outpatient hand surgery clinic. Patients will be consented by the research team if the patient agrees to participate in the research study.
- This will be a single blinded study, and participants will have an equal chance to be placed in either group. Participants will be randomized using permuted block randomization predetermined by our dedicated orthopedic biostatistician into two study groups: those that undergo CTR with adjuvant intra-operative PRP and those that undergo CTR without adjuvant PRP. All participants will have a pre-operative electromyography/nerve conduction study (EMG/NCS).
- Primary outcome measures (BCTQ and grip strength), and secondary outcome measures (PROMIS; 2 point discrimination - thumb, index finger and middle finger; key pinch; 3 finger pinch; and EMG/NCS results) will be collected and stored in REDCap at initial visit. BCTQ and PROMIS will actually be available online for patient to complete at the patient's convenience.
- Patients will undergo CTR with or without adjuvant PRP (based on assigned study group). Patients will not know which group the subject is in (single blinded).
- BCTQ and PROMIS will be collected online at 3 months, 6 months, and 12 months post-operatively. EMG/NCS will only be performed preoperatively and at 12 months post-operatively in the Sports Medicine clinic. At these visits, the investigators will also collect data on 2 point discrimination, grip strength, key pinch, and 3 finger pinch.
- The investigators will store data in REDCap.
- Data will be analyzed with the assistance of our biostatistician, and results will be written up.
研究类型
介入性
注册 (预期的)
46
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Donald Kasitinon, MD
- 电话号码：469-371-7124
- 邮箱：donald.kasitinon@gmail.com
研究联系人备份
- 姓名：Anne Kuwabara, MD
- 邮箱：amk1@stanford.edu
学习地点
-
-
California
-
Redwood City、California、美国、94063
- 招聘中
- Stanford University
-
接触：
- Bahman Adlou, M.Sc.
- 邮箱：badlou@stanford.edu
-
接触：
- Anne Kuwabara, M.D.
-
首席研究员：
- Michael Fredericson, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adult age 18 years and up.
- Diagnosed with severe CTS based on EMG/NCS, meaning those with evidence of axonal loss (absent or low amplitude median sensory nerve action potential and/or absent or low amplitude median motor nerve action potential and/or evidence of abnormal spontaneous activity, reduced recruitment, or motor unit action potential changes on needle EMG of median innervated muscles).
Exclusion Criteria:
- Younger than age 18 years (minor status).
- Diagnosed with concomitant peripheral neuropathy.
- Previous CTR on the affected side.
- Have contraindications to PRP (platelet dysfunction syndrome, critical thrombocytopenia, hemodynamic instability, septicemia, local infection at site of procedure, consistent use of NSAIDs within 48 hours of procedure, steroid injection at treatment site within 1 month, systemic use of steroids within 2 weeks, tobacco use, recent fever or illness, or cancer).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：CTR with PRP
Carpal tunnel release with adjuvant platelet-rich plasma.
|
CTR is performed with adjuvant PRP placed intra-operatively.
|
|
安慰剂比较：CTR without PRP
Carpal tunnel release without adjuvant platelet-rich plasma.
|
CTR is performed without adjuvant PRP placed intra-operatively.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Boston Carpal Tunnel Questionnaire
大体时间：up to 1 month pre-op
|
Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.
|
up to 1 month pre-op
|
|
Boston Carpal Tunnel Questionnaire
大体时间：3 months post-op
|
Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.
|
3 months post-op
|
|
Boston Carpal Tunnel Questionnaire
大体时间：6 months post-op
|
Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.
|
6 months post-op
|
|
Boston Carpal Tunnel Questionnaire
大体时间：12 months post-op
|
Patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome.
|
12 months post-op
|
|
Grip Strength
大体时间：up to 1 month pre-op
|
Measured with a dynamometer.
|
up to 1 month pre-op
|
|
Grip Strength
大体时间：12 months post-op
|
Measured with a dynamometer.
|
12 months post-op
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)
大体时间：up to 1 month pre-op
|
Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome.
|
up to 1 month pre-op
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)
大体时间：3 months post-op
|
Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome.
|
3 months post-op
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)
大体时间：6 months post-op
|
Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome.
|
6 months post-op
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)
大体时间：12 months post-op
|
Computer adaptive test developed to improve precision and reduce question burden for upper extremity conditions such as carpal tunnel syndrome.
|
12 months post-op
|
|
2 Point Discrimination at Thumb
大体时间：up to 1 month pre-op
|
Minimal distance that the patient feels 2 separate points of touch.
|
up to 1 month pre-op
|
|
2 Point Discrimination at Thumb
大体时间：12 months post-op
|
Minimal distance that the patient feels 2 separate points of touch.
|
12 months post-op
|
|
2 Point Discrimination at Index Finger
大体时间：up to 1 month pre-op
|
Minimal distance that the patient still feels 2 separate points of touch.
|
up to 1 month pre-op
|
|
2 Point Discrimination at Index Finger
大体时间：12 months post-op
|
Minimal distance that the patient still feels 2 separate points of touch.
|
12 months post-op
|
|
2 Point Discrimination at Middle Finger
大体时间：up to 1 month pre-op
|
Minimal distance that the patient still feels 2 separate points of touch.
|
up to 1 month pre-op
|
|
2 Point Discrimination at Middle Finger
大体时间：12 months post-op
|
Minimal distance that the patient still feels 2 separate points of touch.
|
12 months post-op
|
|
Key Pinch
大体时间：up to 1 month pre-op
|
Measured with a pinch meter.
|
up to 1 month pre-op
|
|
Key Pinch
大体时间：12 months post-op
|
Measured with a pinch meter.
|
12 months post-op
|
|
3 Finger Pinch
大体时间：up to 1 month pre-op
|
Measured with a pinch meter.
|
up to 1 month pre-op
|
|
3 Finger Pinch
大体时间：12 months post-op
|
Measured with a pinch meter.
|
12 months post-op
|
|
Median Motor Latency
大体时间：up to 1 month pre-op
|
From EMG/NCS data.
|
up to 1 month pre-op
|
|
Median Motor Latency
大体时间：12 months post-op
|
From EMG/NCS data.
|
12 months post-op
|
|
Median Motor Amplitude
大体时间：up to 1 month pre-op
|
From EMG/NCS data.
|
up to 1 month pre-op
|
|
Median Motor Amplitude
大体时间：12 months post-op
|
From EMG/NCS data.
|
12 months post-op
|
|
Median Sensory Latency
大体时间：up to 1 month pre-op
|
From EMG/NCS data.
|
up to 1 month pre-op
|
|
Median Sensory Latency
大体时间：12 months post-op
|
From EMG/NCS data.
|
12 months post-op
|
|
Median Sensory Amplitude
大体时间：up to 1 month pre-op
|
From EMG/NCS data.
|
up to 1 month pre-op
|
|
Median Sensory Amplitude
大体时间：12 months post-op
|
From EMG/NCS data.
|
12 months post-op
|
|
EMG of Abductor Pollicis Brevis
大体时间：up to 1 month pre-op
|
From EMG/NCS data - looking at spontaneous activity.
|
up to 1 month pre-op
|
|
EMG of Abductor Pollicis Brevis
大体时间：12 months post-op
|
From EMG/NCS data - looking at spontaneous activity.
|
12 months post-op
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年10月15日
初级完成 (预期的)
2023年3月31日
研究完成 (预期的)
2023年6月30日
研究注册日期
首次提交
2021年3月10日
首先提交符合 QC 标准的
2021年3月19日
首次发布 (实际的)
2021年3月23日
研究记录更新
最后更新发布 (实际的)
2022年4月20日
上次提交的符合 QC 标准的更新
2022年4月18日
最后验证
2022年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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