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临床试验/NCT03792945
NCT03792945已完成4 期

Comparison of the Efficacy of Corticosteroid Injection and Extracorporeal Shock Wave Therapy (ESWT) in Patients With Carpal Tunnel Syndrome; A Prospective Randomized Controlled Trial

Ahi Evran University Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年1月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Visual Analog Scale (VAS) - Pain

研究概览

简要总结

In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal shock wave therapy) and local corticosteroid injection in patients with carpal tunnel syndrome(CTS) compared to participants receiving only splint and exercise therapy. And the investigators wanted to show that ESWT, a noninvasive treatment modality, is as effective and reliable as local corticosteroid injection, which is the least invasive treatment. Mild and moderate CTS patients will be determined according to American Association of Electrodiagnostic Medicine (AAEM) criteria. 90 idiopathic moderate and mild CTS patients will be included in the study. The participants will be informed about their participation in a study and written informed consent will be obtained.The demographic characteristics and disease duration of the participants will be recorded.The participants will be randomly divided into 3 groups.40 mg of local methylprednisolone (depomedrol) injection will be applied to Group 1 once.

And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3 weeks and hand wrist rest splints will be given for 3 months especially at night when it is not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. The evaluations will be repeated before treatment, after the first week after treatment (first ESWT application) and at the 3rd month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome questionnaire, visual analog scale and dynamometer.

Electromyogram (EMG) data will be recorded before and 3 months after treatment. During the trial, the routine will not be excluded.

详细描述

In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal shock wave therapy) and local corticosteroid injection compared to participants receiving only splint and exercise therapy. And the investigators wanted to show that ESWT, a noninvasive treatment modality, is as effective and reliable as local corticosteroid injection, which is the least invasive treatment. Mild and moderate CTS patients will be determined according to American Association of Electrodiagnostic Medicine (AAEM) criteria. Cervical radiculopathy, polyneuropathy, brachial plexopathy, systemic corticosteroid treatment, fracture and trauma history of the treated side anterior arm and wrist, inflammatory rheumatic disease, pregnant and lactating participants, participants with cardiac pacemakers, participants undergoing carpal tunnel syndrome surgery, thoracic outlet syndrome, severe atrophy, severe carpal tunnel syndrome, participants who are unwilling or unable to participate for any reason, and those who have been decided by the clinician that the participants is not in favor of the participants, systemic diseases such as renal failure, peptic ulcer, dm, hypothyroidism, coagulation disorder will be excluded.90 idiopathic moderate and mild CTS participants will be included in the study. The participants will be informed about their participation in a study and written informed consent will be obtained.The demographic characteristics and disease duration of the participants will be recorded. The participants will be randomly divided into 3 groups.40 mg of local methylprednisolone (depomedrol) injection will be applied to Group 1 once.

And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3 weeks and hand wrist rest splints will be given for 3 months especially at night when it is not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. The evaluations will be repeated before treatment, after the first week after treatment (first ESWT application) and at the 3rd month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome questionnaire, visual analog scale and dynamometer. Electromyogram (EMG) data will be recorded before and 3 months after treatment. During the trial, the routine will not be excluded.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Women and male patients with carpal tunnel syndrome, tendinitis, tenosynovitis diagnosed between 18-65 years of age with clinical and EMG.
  • Patients who are able to understand and correctly understand the patient information form
  • Patients consenting to participate in the study according to the informed consent form

排除标准

  • Cervical radiculopathy
  • Polyneuropathy
  • Brachial plexopathy
  • Systemic corticosteroid treatment
  • Fracture and trauma history of the treated side anterior arm and wrist
  • Inflammatory rheumatic disease
  • Pregnant and lactating patients
  • Patients with cardiac pacemakers
  • Patients undergoing carpal tunnel syndrome surgery
  • Thoracic outlet syndrome
  • Severe atrophy
  • Severe carpal tunnel syndrome
  • Patients who are unwilling or unable to participate for any reason, and those who have been decided by the clinician that the patient is not in favor of the patient,
  • Systemic diseases such as renal failure, peptic ulcer, dm, hypothyroidism, coagulation disorder

研究组 & 干预措施

extracorporeal shock wave therapy

Active Comparator

ESWT will be applied to Group 1 once a week for a total of 3 weeks. Modus ESWT device will be used. The patient's wrist will be applied at a pressure of 4 bar and 2000 Hz at a frequency of 5 Hz. Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.

干预措施: extracorporeal shock wave therapy (Device)

local injection

Active Comparator

40 mg of local Depomedrol (methylprednisolone) injection will be applied to group 2 once. Injection will be made from wrist with carpal tunnel syndrome.Patients will be given a splint at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.

干预措施: local injection (Drug)

结局指标

主要结局

Visual Analog Scale (VAS) - Pain

时间窗: 3. months after treatment

VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line.The participant is asked to mark the point indicating his/her status on this line.The patient marks his current state on this line.The length of the distance from where the pain is no longer to the point marked by the patient indicates the pain of the patient.The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10.The distance of the point marked by the participant is measured in millimeters.And divided into 10.This value gives the participant's pain score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad. The scale has no subscales and total score.

Visual Analog Scale (VAS) - Numbness

时间窗: 3. months after treatment

VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line. The participant is asked to mark the point indicating his / her status on this line. The patient marks his current state on this line. The length of the distance from where the numbness is no longer to the point marked by the patient indicates the numbness of the patient. The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10. The distance of the point marked by the participant is measured in millimeters. And divided into 10. This value gives the participant's numbness score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad.The scale has no subscales and total score.

次要结局

  • hand clamping force(3. months after treatment)
  • boston scale(3. months after treatment)
  • Median nerve sensory distal latency(electrophysiological examination,physiological parameter)(3. months after treatment)
  • Median nerve sensory transmission rate( electrophysiological examination, physiological parameter)(3. months after treatment)
  • Median nerve motor distal latency( electrophysiological examination, physiological parameter)(3. months after treatment)
  • Median nerve motor transmission rate ( electrophysiological examination, physiological parameter)(3. months after treatment)
  • Median sensory nerve action potential amplitude(3. months after treatment)
  • Compound muscle action potential amplitude(3. months after treatment)

研究者

发起方
Ahi Evran University Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Havva Öztürk Durmaz

Research Assistant Doctor Havva ÖZTÜRK DURMAZ

Ahi Evran University Education and Research Hospital

研究点 (1)

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