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临床试验/NCT07420764
NCT07420764已完成不适用

Comparison Of The Effectiveness Of Wrist Splint And Kinesiotaping Treatments In Patients With Lateral Epicondylitis

Konya Beyhekim Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

Lateral epicondylitis, also known as tennis elbow, is a common condition that causes pain in the elbow and forearm, especially in people who perform repetitive wrist movements. In most patients, symptoms improve over time, but in some cases, pain may persist for longer periods.Exercise programs are commonly used in treatment to reduce pain and improve arm function. Kinesiology taping is another method that may help reduce pain by improving blood circulation and supporting muscle movement. Wrist-hand splints are also used to allow the affected muscles to rest by keeping the wrist in a supported position, which may help reduce pain and improve daily activities.The aim of this study is to compare the effectiveness of kinesiology taping and wrist splint use in the treatment of patients with lateral epicondylitis.

详细描述

This study was designed as a prospective, randomized, controlled clinical trial to compare the effectiveness of wrist splint and kinesiotaping treatments in patients diagnosed with lateral epicondylitis.

A total of 150 patients aged between 18 and 65 years who were clinically diagnosed with lateral epicondylitis were included in the study. Patients were randomly allocated into three groups: the kinesiotaping group, the wrist splint group, and the control group, with 50 patients in each group.

The kinesiotaping group received kinesiotaping applications twice a week for a total of six sessions using muscle inhibition and epidermis-dermis-fascia (EDF) techniques. The wrist splint group was instructed to use a static wrist-hand splint for three weeks. The control group received cold application and a home exercise program.

All groups were provided with standardized cold application and home exercise programs. Patients were evaluated at baseline, at the end of treatment, and at the fourth week after treatment. Outcome measures included pain intensity assessed by the Visual Analog Scale (VAS), grip strength measured with a Jamar dynamometer, functional status assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and the Patient-Rated Tennis Elbow Evaluation (PRTEE), quality of life assessed with the Short Form-36 (SF-36), and treatment satisfaction evaluated using the Roles and Maudsley score.

The primary objective of this study was to compare the effects of kinesiotaping using muscle inhibition and epidermis-dermis-fascia techniques and wrist splint use on pain, functional outcomes, grip strength, and quality of life in patients with lateral epicondylitis.

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
None

盲法说明

Due to the nature of the interventions, including kinesiotaping and wrist splint use, masking of participants and investigators was not feasible. Therefore, the study was conducted as an open-label trial.

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

  • Age 18-65 years
  • Clinically diagnosed lateral epicondylitis
  • Elbow pain for at least 3 months
  • Ability to understand and comply with study procedures
  • Written informed consent provided

排除标准

  • Previous surgery to the affected elbow
  • Corticosteroid injection to the affected elbow within the last 6 months
  • Neurological disorders affecting the upper extremity
  • Inflammatory rheumatic diseases and fibromyalgia
  • Fracture or trauma of the upper extremity within the last 6 months
  • Pregnancy
  • Participation in another clinical study during the study period

研究组 & 干预措施

Kinesiotaping

Other

Participants received kinesiotaping treatment in addition to standard cold application and a home exercise program.

干预措施: Kinesiotaping (Other)

Kinesiotaping

Other

Participants received kinesiotaping treatment in addition to standard cold application and a home exercise program.

干预措施: Conservative treatment (Other)

Wrist-Hand Splint

Other

Participants used a static wrist-hand splint in addition to standard cold application and a home exercise program.

干预措施: Wrist-Hand Splint (Device)

Wrist-Hand Splint

Other

Participants used a static wrist-hand splint in addition to standard cold application and a home exercise program.

干预措施: Conservative treatment (Other)

Control Group

Other

Participants received conservative treatment consisting of cold application and a home exercise program.

干预措施: Conservative treatment (Other)

结局指标

主要结局

Pain intensity

时间窗: All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.

Pain intensity was assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).

次要结局

  • Grip strength(All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.)
  • Upper extremity function(All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.)
  • Health-related quality of life(All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.)
  • Treatment satisfaction(All assessments were conducted by the same evaluator at the end of the 3-week treatment period, and 4 weeks following treatment completion.)
  • Patient-Rated Forearm Evaluation Questionnaire) (PRFEQ)(All assessments were conducted by the same evaluator at baseline, at the end of the 3-week treatment period, and 4 weeks following treatment completion.)

研究者

发起方
Konya Beyhekim Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

fatma sümeyye suna

Principal İnvestigator/ Medical Doctor

Konya Beyhekim Training and Research Hospital

研究点 (1)

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