Investigation of the Efficiency of Radial Extracorporeal Shock Wave Therapy at Different Pulses in Patients With Carpal Tunnel Syndrom a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Visual analogue scale (VAS)
研究概览
简要总结
Different parameters have been used in studies investigating the efficacy of extracorporeal shock wave therapy in the treatment of carpal tunnel syndrome. Although extracorporeal shock wave therapy has been shown to have a positive effect on carpal tunnel syndrome, there is no consensus on which pulse rate is more effective. Therefore, in this study, the efficacy of extracorporeal shock wave therapy applied at different pulse rates in the treatment of carpal tunnel syndrome will be examined.
详细描述
The study included 72 patients with CTS aged 18-65 years who applied to Kırşehir Ahi Evran University Training and Research Hospital Physical Therapy and Rehabilitation Center.
Carpal tunnel syndrome (CTS) is the most common compressive neuropathy. In CTS, the median nerve is compressed within the carpal canal, about 1 to 2 cm beyond the distal wrist crease. It is more common in women and is typically more severe in the dominant hand but is often bilateral. Repetitive hand and wrist movements, such as using a keyboard or vibrating tools, have been associated with CTS. Medical conditions associated with CTS include diabetes, hypothyroidism and RA, as well as obesity and pregnancy. Rarely, CTS may be caused by a mass lesion in the wrist, such as a ganglion cyst or neurofibroma, or may be associated with acute trauma to the wrist. The vast majority of CTS cases are idiopathic.
CTS treatment is divided into conservative and surgical treatment. Conservative treatment methods are recommended in mild and moderate CTS patients, while surgical treatment is recommended in severe cases.
Extracorporeal Shock Wave Therapy is one of the physical therapy applications used in the treatment of Carpal Tunnel. The effectiveness of ESWT in the treatment of CTS will be examined
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
- Single (Investigator)
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
- 否
入选标准
- •Male and female patients aged 18-65 years with carpal tunnel syndrome diagnosed clinically and by EMG
- •Patients who can correctly understand what is stated in the patient information form and who can cooperate
- •Patients who consent to participate in the study according to the informed consent form will be included in the study.
排除标准
- •Cervical radiculopathy
- •Polyneuropathy
- •Brachial plexopathy
- •Use of systemic corticosteroids or local corticosteroid injections
- •History of fracture and trauma in the forearm and wrist on the treated side
- •Inflammatory rheumatic disease
- •Pregnant and lactating patients
- •Systemic diseases such as renal failure, peptic ulcer, DM, hypothyroidism, coagulation disorder
- •Patients undergoing carpal tunnel syndrome surgery
- •People with pacemakers
- •Thoracic outlet syndrome
- •Tenar atrophy, severe carpal tunnel syndrome
研究组 & 干预措施
two thousand pulse ESWT Group
ESWT will be applied to the patient's wrist and conventional treatment consisting of hand-wrist rest splint and nerve gliding exercises will be applied. The point of the ESWT site was located by ultrasonography interfaced with a 5-12 MHz linear array transducer, and the median nerve was visualized at the line of the proximal carpal tunnel (scaphoid pisiform level). (0,06 mj/mm2, 2000 impulses, 4 bar) (Modus ESWT Radial Shockwave Therapy)
干预措施: extracorporeal shockwave therapy (Device)
Conventional Control Group
The patient will receive conventional treatment consisting of hand-wrist rest splint and nerve gliding exercises as directed by the physiotherapist
one thousand pulse ESWT Group
ESWT will be applied to the patient's wrist and conventional treatment consisting of hand-wrist rest splint and nerve gliding exercises will be applied. The point of the ESWT site was located by ultrasonography interfaced with a 5-12 MHz linear array transducer, and the median nerve was visualized at the line of the proximal carpal tunnel (scaphoid pisiform level). (0,06 mj/mm2, 1000 impulses, 4 bar) (Modus ESWT Radial Shockwave Therapy)
干预措施: extracorporeal shockwave therapy (Device)
结局指标
主要结局
Visual analogue scale (VAS)
时间窗: 0. week , 4. week , 12. week
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
Boston Carpal Tunnel Syndrome Questionnaire
时间窗: 0. week, 4. week , 12. week
It assesses the severity of symptoms and functional status. The symptom severity scale (SSS) assesses symptoms according to severity, frequency, time and type. The scale consists of 11 questions with multiple-choice answers scored from 1 point (mildest) to 5 points (most severe). The overall symptom severity score is calculated as the average of the scores for the 11 individual items. Functional status scale (FSS) assesses the impact of CTS on daily life. The scale consists of eight multiple-choice questions scored from 1 point (no difficulty in the activity) to 5 points (unable to do the activity at all). The total score for functional status was calculated as the average of all eight. Therefore, a higher symptom severity or functional status score indicates worse symptoms or impaired function.
次要结局
- Ultrasonography(0. week, 12. week)
- Hand grip strength measurement(0. week, 4. week, 12. week)
- Electromyoneurography (EMNG)(0. week, 12. week)
研究者
Ibrahim Dogru
Physical medicine and rehabilitation MD
Ahi Evran University Education and Research Hospital