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临床试验/NCT07170839
NCT07170839已完成不适用

Comparison of Eccentric and Combined Isotonic Exercises Combined With Extracorporeal Shock Wave Therapy in the Treatment of Lateral Epicondylitis

Inonu University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Pain assessment

研究概览

简要总结

This study was designed to investigate the effectiveness of the combined isotonic exercise technique applied with extracorporeal shock waves in the treatment of lateral epicondylitis.

Individuals aged 39-65 diagnosed with lateral epicondylitis were randomized using a sealed envelope method to one of the following groups: extracorporeal shock wave therapy, eccentric exercise and extracorporeal shock wave therapy, or combined isotonic exercise and extracorporeal shock wave therapy. Patients in the combined isotonic exercise and eccentric exercise groups were enrolled in a rehabilitation program under the supervision of a physiotherapist three days a week for five weeks. Extracorporeal shock wave therapy was also administered once a week for five weeks for all three groups. Pain intensity was assessed using the Visual Analog Scale, pressure pain threshold algometer, muscle strength using a hand-held dynamometer, grip strength using a digital hand-held dynamometer, and functionality using the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH).

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 (Participant)

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

  • •Diagnosis of lateral epicondylitis
  • •Having elbow pain lasting longer than 8 weeks
  • •Diagnosis of unilateral lateral epicondylitis
  • •Being a woman or man between the ages of 18 and 65
  • •No other lesions in or around the elbow

排除标准

  • •Cardiovascular, neurological, and neuromuscular diseases
  • •Prior trauma to the elbow area and previous elbow treatment
  • •Prior elbow surgery
  • •Peripheral nerve entrapment
  • •Corticosteroid injection within 6 months
  • •Bilateral elbow pain

研究组 & 干预措施

ESWT Application

Experimental

A total of 5 sessions of ESWT were applied to all 3 groups, once a week for 5 weeks.

干预措施: ESWT Aplication (Other)

Eccentric Treatment Protocol

Experimental

Patients in the eccentric exercise group underwent a protocol consisting of slow-progressive eccentric exercise of the wrist extensors combined with static stretching exercise, 3 times a week for 5 weeks.

干预措施: ECCENTRIC EXERCISE (Other)

Combined Isotonic Exercise

Experimental

Patients in the combined isotonic exercise group underwent an eccentric-concentric exercise protocol combined with wrist isometric exercises 3 days a week for 5 weeks.

干预措施: COMBINED ISOTONIC EXERCISE (Other)

结局指标

主要结局

Pain assessment

时间窗: 5 weeks

To determine patients' pain levels, pain intensity at rest and during activity was measured using a Visual Analog Scale (VAS). A 10-centimeter (cm) horizontal line was used on this scale, grading from "0: no pain" to "10: unbearable pain." Patients were asked to rate their current pain within this range.

Pressure Pain Assessment

时间窗: 5 weeks

An algometer was used to measure the pressure pain threshold. The 1-cm tip of the device was placed perpendicular to the patient's arm, with the arm in 30 degrees of abduction and the elbow in 90 degrees of flexion, and the forearm and wrist supported. The patient was asked to report the first time the applied pressure produced pain. This value was recorded on an assessment form in kg/cm².

Muscle Strength Assessment

时间窗: 5 weeks

Wrist extensor and middle finger muscle strength were measured using a hand-held dynamometer (Lafayette Instrument®, Lafayette, UK). The device was placed on the lateral surface of the metacarpal bones while the forearm was resting on the support surface. Participants were asked to perform an isometric contraction against the device in the direction of wrist extension for 5 seconds. The measured values were recorded on an evaluation form. Middle finger extension strength was tested with both the forearm and hand resting on the support surface.

Grip Strength Measurement

时间窗: 5 weeks

A Baseline digital handheld dynamometer (300 LB / 135 KG®) was used to measure maximum grip strength in patients. For this measurement, patients were asked to sit upright in a chair. With the arm and shoulder in a neutral position, the elbow in 90-degree flexion, the forearm in neutral, the wrist in slight extension, and ulnar deviation, the patient was instructed to squeeze the dynamometer firmly. The measured value was recorded in kilograms (kg). Three repetitions were performed for the affected hand, with a 1-minute rest period between repetitions. Grip strength was objectively measured by averaging these three values.

Determining the Functionality Level

时间窗: 5 weeks

The Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), developed for use in upper extremity musculoskeletal disorders, was used to determine patients' functional levels and symptoms. This questionnaire consists of three sections and 30 questions. Twenty-one questions address difficulties experienced by patients related to activities, five address disease symptoms, and the remaining questions assess work, sleep, social function, and patient self-confidence.

Pain assessment

时间窗: Baseline

To determine patients' pain levels, pain intensity at rest and during activity was measured using a Visual Analog Scale (VAS). A 10-centimeter (cm) horizontal line was used on this scale, grading from "0: no pain" to "10: unbearable pain." Patients were asked to rate their current pain within this range.

Pressure Pain Assessment

时间窗: Baseline

An algometer was used to measure the pressure pain threshold. The 1-cm tip of the device was placed perpendicular to the patient's arm, with the arm in 30 degrees of abduction and the elbow in 90 degrees of flexion, and the forearm and wrist supported. The patient was asked to report the first time the applied pressure produced pain. This value was recorded on an assessment form in kg/cm².

Muscle Strength Assessment

时间窗: Baseline

Wrist extensor and middle finger muscle strength were measured using a hand-held dynamometer (Lafayette Instrument®, Lafayette, UK). The device was placed on the lateral surface of the metacarpal bones while the forearm was resting on the support surface. Participants were asked to perform an isometric contraction against the device in the direction of wrist extension for 5 seconds. The measured values were recorded on an evaluation form. Middle finger extension strength was tested with both the forearm and hand resting on the support surface.

Grip Strength Measurement

时间窗: Baseline

A Baseline digital handheld dynamometer (300 LB / 135 KG®) was used to measure maximum grip strength in patients. For this measurement, patients were asked to sit upright in a chair. With the arm and shoulder in a neutral position, the elbow in 90-degree flexion, the forearm in neutral, the wrist in slight extension, and ulnar deviation, the patient was instructed to squeeze the dynamometer firmly. The measured value was recorded in kilograms (kg). Three repetitions were performed for the affected hand, with a 1-minute rest period between repetitions. Grip strength was objectively measured by averaging these three values.

Determining the Functionality Level

时间窗: Baseline

The Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), developed for use in upper extremity musculoskeletal disorders, was used to determine patients' functional levels and symptoms. This questionnaire consists of three sections and 30 questions. Twenty-one questions address difficulties experienced by patients related to activities, five address disease symptoms, and the remaining questions assess work, sleep, social function, and patient self-confidence.

次要结局

未报告次要终点

研究者

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

BÜŞRA CANDİRİ

assistant professor

Inonu University

研究点 (1)

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