Safety and Effectiveness of Fluoroscopy-Guided Acupotomy for Carpal Tunnel Syndrome: Protocol for a Pilot Randomized, Patient-Assessor Blind, Parallel Clinical Trial원문보기
Background: In Korean medicine, carpal tunnel syndrome is treated by stimulating the acupoints around the wrist. Although a deep understanding of anatomy and guidance is needed to stimulate these acupoints to avoid undesirable side-effects, currently there are no published guidelines for acupotomy t...
Background: In Korean medicine, carpal tunnel syndrome is treated by stimulating the acupoints around the wrist. Although a deep understanding of anatomy and guidance is needed to stimulate these acupoints to avoid undesirable side-effects, currently there are no published guidelines for acupotomy treatment. The aim of this study is to evaluate the effectiveness and safety of fluoroscopy-guided acupotomy compared with conventional acupotomy treatment. Methods: This is a randomized, patient-assessor, patient blind, parallel clinical trial. A total of 30 patients will be enrolled at Wonkwang University Gwangju Hospital, and will be allocated to either an experimental group or a control group. The experimental group will be treated using fluoroscopy-guided acupotomy and the control group will be treated using the conventional acupotomy method. Results: The primary outcome measure will be identification of a cross-section area of the median nerve measured by ultrasonography, and the secondary outcome measure will be the alleviation of pain measured by the Visual Analogue Scale, improvement in the Nerve Conduction Study, Tinel test, Phalen's test, EuroQol 5-dimension scale, and Boston Carpal Tunnel Questionnaire score. Safety components will be measured by monitoring vital signs, electrocardiographs, blood tests, general chemical tests, urine tests and pregnancy tests. In addition, observations for adverse effects will be performed during the trial. Conclusion: This study will provide a more effective, and less harmful way of treating carpal tunnel syndrome compared with conventional acupotomy. Fluoroscopy-guided acupotomy will help practitioners to be accurate in direction and depth of the needle for treating carpal tunnel syndrome.
Background: In Korean medicine, carpal tunnel syndrome is treated by stimulating the acupoints around the wrist. Although a deep understanding of anatomy and guidance is needed to stimulate these acupoints to avoid undesirable side-effects, currently there are no published guidelines for acupotomy treatment. The aim of this study is to evaluate the effectiveness and safety of fluoroscopy-guided acupotomy compared with conventional acupotomy treatment. Methods: This is a randomized, patient-assessor, patient blind, parallel clinical trial. A total of 30 patients will be enrolled at Wonkwang University Gwangju Hospital, and will be allocated to either an experimental group or a control group. The experimental group will be treated using fluoroscopy-guided acupotomy and the control group will be treated using the conventional acupotomy method. Results: The primary outcome measure will be identification of a cross-section area of the median nerve measured by ultrasonography, and the secondary outcome measure will be the alleviation of pain measured by the Visual Analogue Scale, improvement in the Nerve Conduction Study, Tinel test, Phalen's test, EuroQol 5-dimension scale, and Boston Carpal Tunnel Questionnaire score. Safety components will be measured by monitoring vital signs, electrocardiographs, blood tests, general chemical tests, urine tests and pregnancy tests. In addition, observations for adverse effects will be performed during the trial. Conclusion: This study will provide a more effective, and less harmful way of treating carpal tunnel syndrome compared with conventional acupotomy. Fluoroscopy-guided acupotomy will help practitioners to be accurate in direction and depth of the needle for treating carpal tunnel syndrome.
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문제 정의
The objective of this study is to compare the safety and effectiveness between fluoroscopy-guided acupotomy and the use of acupotomy using the gol-do-bun-chon method for treating CTS.
제안 방법
In this study, the design of the protocol for evaluating the effectiveness and safety of acupotomy on CTS using the portable fluoroscopic X-ray system (PF X-ray) compared with using the goldo-bun-chon method is provided.
The experimental group will be treated by fluoroscopy-guided acupotomy and the control group will be treated using acupotomy following the gol-do-bun-chon method. The treatment will be performed after measuring the pun and chon of the subject. After the treatment, the patient will be monitored for adverse events.
The treatment will be performed by a doctor specialized in acupuncture with over 10 years’ experience in clinical practice.
This study protocol is intended to evaluate the effectiveness and safety of fluoroscopy-guided acupotomy for the treatment of CTS. In addition, the rate of accurate location of acupoints can be evaluated compared with conventional acupuncture using the conventional proportional method.
대상 데이터
A total of 30 participants will be enrolled in this study. Each participant will receive an explanation of the study procedure and will be asked to sign the consent form.
A total of 30 patients will be enrolled in the trial. Patients who sign the clinical trial agreement by voluntary consent will be assessed by inclusion and exclusion criteria.
Thus, as a pilot study, considering feasibility rationale and precision of the mean and variance, the sample size of this study is measured as 12 for both the experimental and control groups [8]. Considering 20% drop out rate from the study, a total of 30 patients (15 for each group) will be recruited for this study.
As of March 2019, the trial is ongoing. The first patient was enrolled on 23 March 2018.
This is a randomized, patient-assessor, blind, parallel clinical trial targeting CTS patients. The trial will be conducted at the South Korea Wonkwang University, Gwangju Hospital. The schedule of study procedures is shown in Table 1 and a flow chart of the study is shown in Fig.
데이터처리
The 100 mm pain VAS, NCS test, Tinel’s test, Phalen’s test, EQ-5D, cross-sectional area of the median nerve measured by ultrasonography, and BCTQ score will be compared between treatment and control group, before and after treatment. The intergroup differences in the comparisons of the means will be analyzed using the paired t test, and the intragroup comparisons of the mean values will be analyzed with a 2-sample t test. The difference in the interaction of treatment by time will be analyzed by repeated-measures analysis of variance.
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