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临床试验/NCT06674668
NCT06674668招募中不适用

Immediate Effect of Wearable Vibrotactile Stimulation on Pain and Sense in Patients with Lateral Epicondylitis

Medipol University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
33
试验地点
1
主要终点
Pain Severity

研究概览

简要总结

It is aimed to investigate the immediate effect of vibrotactile stimulation on pain, sense and functionality in patients with lateral epicondylitis.

详细描述

Lateral epicondylitis (LE) is a chronic degenerative disease of the attachment site of the extensor tendons to the lateral epicondyle of the humerus. The annual incidence is 1-3% of the world population and is most common between the ages of 30 and 60. Although LE is often called "tennis elbow," a small percentage of patients play tennis. The etiology of the disease is multifactorial, and it is generally thought to be caused by repetitive wrist activities that include gripping, wrist extension, and supination. Most patients recover spontaneously within 1-2 years. However, loss of work capacity is quite common in jobs that require the use of the upper extremity.

The pathophysiology of the disease is currently explained by degenerative mechanisms instead of the idea of inflammatory infiltration. Microtears and tendinosis caused by increased force on the tendon are supported by ultrasonographic examinations. However, currently, pain and functional disability in daily life are explained by sensory changes such as pain pressure threshold, impaired vibration perception and joint position sense rather than tendon structure changes. Clinically, lateral elbow pain results in decreased grip strength and proprioception, and consequently loss of function.

In LE management, the aim is to relieve pain, minimize excessive loads on the arm and restore the patient to optimal daily life activities and former functionality.

While there is insufficient evidence on the effectiveness of surgical interventions in treatment, nonoperative methods are frequently preferred. Patient education, use of splints, medical treatments, biological treatments, physical agents, taping, and manual therapy approaches are frequently used. While conservative treatments remain up-to-date for pain and disability, the most appropriate treatment strategy is controversial.

The use of technology in physiotherapy has been increasing in recent years. In addition to motor movement, the development of sensory skills is also emphasized. On the other hand, vibrotactile stimulation has been reported to contribute to the sensory processing mechanism by causing different activity levels in the brain. There are no studies in the literature investigating the effects of wearable vibration technology on sensory parameters in LE patients. The aim of this study is to investigate the effects of wearable vibrotactile application on pain, sensation and upper extremity function compared to traditional physiotherapy in patients with LE.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

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

  • Being between 18-65 years of age
  • Patients diagnosed with lateral epicondylitis

排除标准

  • Having had elbow surgery
  • Having a history of congenital or acquired orthopedic, neurological, or rheumatological conditions affecting the upper limb
  • Having received any conservative treatment for the diagnosis of lateral epicondylitis

结局指标

主要结局

Pain Severity

时间窗: from pre-interventional time to post-interventional about 1st hour

A 10 cm visual analog scale (VAS) was used to assess pain intensity. A horizontal 10 cm ruler was used (0 = no pain and 10 = worst pain).

Pressure pain threshold

时间窗: from pre-interventional time to post-interventional about 1st hour

The J tech brand algometer device will be used for the pressure pain threshold measurement. The trigger points will be found by palpation. The person will be told that the device will apply pressure to the trigger point and that they will give the command "stop" when they first feel the pain.

Joint position sense

时间窗: from pre-interventional time to post-interventional about 1st hour

Elbow joint position sense will be measured with an inclinometer for 45 and 60 degree flexion target angle. The elbow will be brought to the target angle and they will be asked to memorize the movement by holding it for 10 seconds. Then, they will be asked to bring the target force they learned themselves. The absolute value of the difference between the target value and the last measurements will be taken as the error score.

次要结局

  • Hand grip sensitivity level(from pre-interventional time to post-interventional about 1st hour)
  • Grip Strength(from pre-interventional time to post-interventional about 1st hour)
  • Functional assessment(2 weeks)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Imge NAS

Lecturer

Istanbul Kültür University

研究点 (1)

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