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临床试验/NCT05475808
NCT05475808进行中(未招募)4 期

Comparison of the Efficacy of Different Treatment Methods in Patients With Carpal Tunnel Syndrome

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年8月1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
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Boston Carpal Tunnel Syndrome Questionnaire

研究概览

简要总结

It is aimed to compare the effects of different conservative methods on the clinical condition of the patients, hand grip and pinch strengths and wrist muscle strengths in patients with carpal tunnel syndrome.

详细描述

Carpal tunnel syndrome (CTS) is one of the most common entrapment neuropathies. It occurs as a result of compression or irritation of the median nerve as it passes through the carpal tunnel in the wrist. It is seen in 1-4% of the general population.In nerve conduction studies, patients with mild and moderate CTS are treated with conservative treatment methods, while patients with severe nerve conduction findings and thenar atrophy are treated surgically.Although there are many methods used in the conservative treatment of carpal tunnel syndrome, there is no definite data about which treatment option to choose.The most commonly used conservative method is the wrist rest splint application, which is based on the principle of resting the wrist.In addition, there are tendon and nerve gliding exercises that facilitate nerve and tendon movements. Physical therapy agents such as Tens, Laser and Ultrasound can be used in the treatment of CTS. Non-Steroidal anti-inflammatory drugs and B6 vitamins can be used as drug therapy. Apart from these, local corticosteroid injections can be applied from the wrist.

There are studies comparing conservative treatment methods in carpal tunnel syndrome. However, these are generally in the form of studies that measure and compare the effects of treatments on the clinical condition of their patients and on hand grip and finger pinch strength. There is no comparative study investigating the effects of conservative treatment methods on wrist muscle strength in patients with carpal tunnel syndrome.

It was observed that wrist muscle strength decreased in patients with CTS compared to normal patients. Wrist muscle strength is important in hand and wrist functions as well as hand grip and pinch strength are important.

Flexion-extension, radial-ulnar deviation and supination-pronation muscle strengths of the patients' wrists can be measured with an isokinetic dynamometer device.

It is aimed to compare the effects of different conservative methods on the clinical condition of the patients, hand grip and pinch strengths and wrist muscle strengths in patients with carpal tunnel syndrome.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with mild to moderate CTS confirmed by Electromyography
  • Clinically, at least one of the symptoms of hand-wrist pain, numbness, night pain should be present.
  • Clinically, at least one of the Tinel, Phalen, and median nerve compression findings should be present.

排除标准

  • Having a history of trauma and operation on the wrist.
  • Patients who have had previous injections from the wrist
  • Patients with thyroid diseases, diabetes mellitus, systemic peripheral neuropathy and cervical radiculopathy
  • Pregnant patients

研究组 & 干预措施

Splint

Active Comparator

Patients in Group 1 will be applied to only static wrist splint treatment for 8 week.

干预措施: Static wrist splint treatment (Device)

Tendon and nerve gliding exercise

Active Comparator

Patients in Group 2 will be applied to tendon and nerve gliding exercises for the wrist in addition to static wrist splint treatment for 8 week.

干预措施: Static wrist splint treatment (Device)

Tendon and nerve gliding exercise

Active Comparator

Patients in Group 2 will be applied to tendon and nerve gliding exercises for the wrist in addition to static wrist splint treatment for 8 week.

干预措施: Tendon and nerve gliding exercises (Other)

local steroid injection

Active Comparator

Patients in Group 3 will be applied to local steroid injection to wrist in addition to static wrist splint treatment for 8 week.

干预措施: Static wrist splint treatment (Device)

local steroid injection

Active Comparator

Patients in Group 3 will be applied to local steroid injection to wrist in addition to static wrist splint treatment for 8 week.

干预措施: Wrist local steroid injection (Drug)

结局指标

主要结局

Boston Carpal Tunnel Syndrome Questionnaire

时间窗: 8 week after treatment

This questionnaire consists of two parts: Boston Symptom Severity Scale (BSSS) and Boston Functional Capacity Scale (BFCS). BSSS consists of 11 questions, and BFCS consists of 8 questions. The score of each question varies between 1-5. High scores indicate severe symptoms and reduced functional capacity.

Visual Analogue Scale

时间窗: 8 week after treatment

Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).

Isokinetic Muscle Strength Measure

时间窗: 8 week after treatment

Wrist flexion/extension, radial/ulnar deviation, supination/pronation strengths at 60° and 210°/s will be evaluated with an isokinetic test and exercise system (CSMI Cybex). Patients will be seated on the test chair with the backrest set to 90°. The arm to be tested will be secured to the chair's forearm rest. The wrist joint will be positioned in neutral. The forearm stabilizer pad and strap will secure the distal aspect of the forearm of the test hand. Wrist flexion/extension range of motion, radial/ulnar deviation range of motion, supination/pronation range of motion will be set within each patients' available range. Patients will be permitted 4 experimental trials to become familiar with the process for each angular velocity, and then they will perform 5 maximal repetitions at 60°/s and 12 maximal repetitions at 210°/s. At the end of the test, muscle strength (Peak Torque) will be measured in Newton meters.

The hand grip strength

时间窗: 8 week after treatment

The hand grip strength of the patients will be measured with a North Coast hydraulic hand dynamometer. The average of 3 different repetitive measurements will be taken.

The finger pinch strength

时间窗: 8 week after treatment

Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.

次要结局

  • Short Form-36 Quality of Life Scale(8 week after treatment)
  • Disabilities of the Arm, Shoulder end Hand Questionnaire(8 week after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Serdar Kilinc

Assistant Professor

Abant Izzet Baysal University

研究点 (1)

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