Comparison of Clinical and Ultrasonographic Efficacy of Two Different Splints Used in the Treatment of Lateral Epicondylitis: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Change of the maximum tendon thickness of the common extensor tendon via ultrasonographic measurement
研究概览
简要总结
Lateral epicondylitis (LE) or tennis elbow; is the most common cause of lateral pain in the elbow, with an incidence of 1-3% in the general population. It is thought to develop as a result of overuse inflammation of the wrist joint extensor tendons, originating from the lateral epicondyle of the humerus. The most common symptom is the pain located in the lateral aspect of the elbow, which can spread across the forearm extensor face and is aggravated by wrist extension, forearm supination, and strong grip movements of the hand. The diagnosis is made by clinical and ultrasonographic evaluations. Significant correlations were found between clinical symptoms of LE and increased joint extensor tendon thickness, focal hypoechogenicity, intratendinous calcification, bone abnormality, and diffuse heterogeneity findings that can be monitored by diagnostic ultrasound. Wait-see policy, conservative treatment regimens, local injections, and surgical approaches are the treatment methods that can be used on a patient-based basis until today. Conservative treatment options include physical therapy modalities such as exercise, massage, laser, electrotherapy, therapeutic ultrasound, extracorporeal shock wave therapy, the use of various splints, ice application, activity modification, rest, NSAIDs, and taping methods. The two prominent bracing methods are the lateral epicondylitis band and the wrist extension splint. Although these two methods are frequently used in daily practice, the limitations of studies investigating the effectiveness of orthoses and which orthosis are more effective draw attention. In comparative studies, some factors may affect clinical results such as allowing patients to use NSAIDs when necessary and organizing a home exercise program. Besides, none of them included a control group and the patients were not evaluated by ultrasonography. This study aims to compare the effects of the use of two different splints (lateral epicondylitis band and wrist extension splint) on clinical and ultrasonographic parameters in patients with a diagnosis of lateral epicondylitis.
详细描述
The study is randomized and controlled. 158 patients will be included in to study who apply to Dokuz Eylül University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Clinic with the complaint of elbow pain, aged between 18-65 years and diagnosed with lateral epicondylitis by clinical and ultrasonographic methods. These patients will be divided into three groups randomly (group1 n:53, group 2 n:53, group 3 n:52).
First group: A lateral epicondylitis bandage will be given to the patient for 6 weeks. The bandage will be positioned 5 cm distal to the lateral epicondyle to allow for elbow flexion. After the application, patients will be asked to punch and the belt on the band will be tightened. After the patients are asked to open the fist, the suitability of the pressure applied to the forearm will be evaluated. Patients will also be asked to repeat this application while wearing the band.
Second group: A wrist extension splint will be given to the patient for 6 weeks. The splint will be used to keep the wrist at 15-20 degrees of extension and to wrap the distal wrist and forearm without hindering finger movements.
Third group: These patients will be monitored with a wait-and-see policy. No splint or band will be given to the patient.
Before treatment, age, gender, occupation, body mass index, duration of symptoms, trauma history, dominant hand, side of the symptom and previous similar complaint history will be questioned in all three groups.
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)
盲法说明
Single (Clinician)
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
- •Applying to Dokuz Eylül University Medical Faculty Physical Medicine and Rehabilitation Department outpatient clinic
- •Having pain in the elbow for less than 12 weeks and having no similar attack history for 1 year
- •Diagnosing lateral epicondylitis with clinical and ultrasonographic evaluation
- •Having pain of at least 3 in their VAS scores
- •Agreeing to participate in the study
排除标准
- •Having elbow pain for more than 12 weeks
- •Having signs of lateral epicondylitis in the other extremity
- •Having a history of injection for lateral epicondylitis
- •In the last 3 months, who had physical therapy for lateral epicondylitis
- •Having a history of elbow surgery and fracture in the elbow area.
- •Having muscle weakness in the upper extremity due to cervical radiculopathy and/or entrapment neuropathy
- •Having malignancy or neurological, rheumatological, and psychiatric disease comorbidities
研究组 & 干预措施
Lateral Epicondylitis Bandage
A lateral epicondylitis bandage will be given to the patient for 6 weeks. The bandage will be positioned 5 cm distal to the lateral epicondyle to allow for elbow flexion. After the application, patients will be asked to punch and the belt on the band will be tightened. After the patients are asked to open the fist, the suitability of the pressure applied to the forearm will be evaluated. Patients will be asked to repeat this application while wearing the band. The patients will also be asked to use the bandage throughout the day, and to remove them during bathing and sleeping.
干预措施: Lateral Epicondylitis Bandage (Device)
Wrist Extension Splint
A wrist extension splint will be given to the patient for 6 weeks. The splint will be used to keep the wrist at 15-20 degrees of extension and to wrap the distal wrist and forearm without hindering finger movements. The patients will be asked to use the splint throughout the day, and to remove them during bathing and sleeping.
干预措施: Wrist Extension Splint (Device)
Wait-and-see Policy
These patients will be monitored with a wait-and-see policy. No splint or band will be given to the patient.
结局指标
主要结局
Change of the maximum tendon thickness of the common extensor tendon via ultrasonographic measurement
时间窗: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic measurements.
The maximum tendon thickness in the capitellar and radiocapitellar regions of the common extensor tendon
Change of the hypoechogenicity of the common extensor tendon via ultrasonographic assessment.
时间窗: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic assessments.
The assessment of hypoechogenicity of the common extensor tendon, Grade 0: Normal fibrillar and hypoechoic structure, Grade 1: hypoechoic lesions affecting less than 30% of whole section of the tendon, Grade 2: hypoechoic lesions affecting more than 30% and less than 50% of the whole section of the tendon, Grade 3: single large or multiple hypoechoic lesions affecting more than 50% of the whole section of the tendon / high-grade tendinosis.
Change of the heterogeneity of the common extensor tendon via ultrasonographic assessment.
时间窗: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic assessments.
The assessment of heterogeneity of the common extensor tendon, Grade 1 = presence, Grade 0 = absence
Change of the neovascularity of the common extensor tendon via ultrasonographic assessment.
时间窗: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment with ultrasonographic assessments.
The assessment of neovascularity of the common extensor tendon, Grade 0 = no detectable neovessels Grade 1 = neovessels detected in less than 30% of the whole section of the tendon Grade 2 = neovessels detected in more than 30% but less than 50% of the whole section of the tendon Grade 3 = neovessels detected in more than 50% of the whole section of the tendon.
Change of the bone abnormality of the lateral epicondyle via ultrasonographic assessment
时间窗: All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week( of the treatment with ultrasonographic assessments.
The assessment of bone abnormality of the lateral epicondyle, Grade 1 = presence, Grade 0 = absence
次要结局
- Change of the pain on the lateral elbow via Visual Analog Scale(All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.)
- Change of the pain on the lateral elbow via Patient Rated Tennis Elbow Evaluation(All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.)
- Change of the functional disability via Patient Rated Tennis Elbow Evaluation(All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.)
- Change of the sensitivity via algometer(All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.)
- Change of the handgrip strength via hand dynamometer(All patients will be evaluated 3 times, before treatment, third week of the treatment, and sixth week of the treatment.)
研究者
Banu Dilek
Assoc Prof
Dokuz Eylul University