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临床试验/NCT07028840
NCT07028840已完成不适用

A Comparison of Extracorporeal Shockwave Therapy (ESWT) and High-intensity Laser Therapy (HILT) in Terms of Pain, Function and Grip Strength in Lateral Epicondilitis: a Randomized Controlled Study

Pamukkale University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年6月10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
42
试验地点
1
主要终点
Pain Severity - Visual Analog Scale (VAS)

研究概览

简要总结

This study aims to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and high-intensity laser therapy (HILT) in improving pain, grip strength, and function in patients with lateral epicondylitis. A total of 42 volunteer patients aged 18-65 were enrolled at Balıkesir Private Sevgi Hospital physical medicine polyclinic. Participants were randomly assigned into three groups: group 1 received conventional physiotherapy, group 2 received physiotherapy plus ESWT, and group 3 received physiotherapy plus HILT. Physiotherapy was applied for 2 weeks, totaling 10 sessions. ESWT and HILT were each administered twice weekly for 2 weeks, totaling 4 sessions. Pain was measured using the visual analog scale (VAS), grip strength with a hand dynamometer, and function using the Duruöz Hand Index and PRTEE-T questionnaire. Evaluations were performed before treatment, after 2 weeks, and one month post-treatment.

详细描述

This randomized controlled clinical trial investigates the effects of extracorporeal shock wave therapy (ESWT) and high-intensity laser therapy (HILT) on pain, grip strength, and function in patients diagnosed with lateral epicondylitis. The study was conducted at the physical medicine polyclinic of Balıkesir Private Sevgi Hospital and included 42 patients aged 18 to 65 who were referred for therapeutic physical therapy after being diagnosed for the first time with lateral epicondylitis.

Participants were randomly divided into three groups:

Group 1: received conventional physiotherapy including hot pack application, transcutaneous electric nerve stimulation (TENS), and stretching/strengthening exercises. Physiotherapy was administered 5 times per week for 2 weeks (total of 10 sessions).

Group 2: received the same physiotherapy as group 1, plus extracorporeal shock wave therapy (ESWT) administered twice per week for 2 weeks (total of 4 sessions).

Group 3: received the same physiotherapy as group 1, plus high-intensity laser therapy (HILT) administered twice per week for 2 weeks (total of 4 sessions).

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

  • •Being over the age of 18,
  • •Being diagnosed with lateral epicondylitis,
  • •Not having received lateral epicondylitis treatment in the last 3 months

排除标准

  • •Stopping the treatment,
  • •Those who have been traumatized in the last 3 months,
  • •Those who use drugs that can affect muscle strength or pain level (muscle relaxants, analgesics, gabapentinoids, etc.)
  • •Those with open wounds in the elbow area, Those with elbow fractures, Those with drug allergies, Pregnant and breastfeeding women.

研究组 & 干预措施

Physiotherapy

Active Comparator

This group received conventional physiotherapy only

干预措施: Physiotherapy (Other)

Physiotherapy + ESWT

Active Comparator

This group received conventional physiotherapy and additional extracorporeal shock wave therapy (ESWT)

干预措施: Physiotherapy (Other)

Physiotherapy + ESWT

Active Comparator

This group received conventional physiotherapy and additional extracorporeal shock wave therapy (ESWT)

干预措施: Extracorporeal Shock Wave Therapy (ESWT) (Device)

Physiotherapy + HILT

Active Comparator

This group received conventional physiotherapy and additional high-intensity laser therapy (HILT).

干预措施: Physiotherapy (Other)

Physiotherapy + HILT

Active Comparator

This group received conventional physiotherapy and additional high-intensity laser therapy (HILT).

干预措施: High-Intensity Laser Therapy (HILT) (Device)

结局指标

主要结局

Pain Severity - Visual Analog Scale (VAS)

时间窗: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion

Pain intensity will be evaluated using the visual analog scale (VAS), a 10 cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Continuous scale (0-10), higher scores indicate worse outcome.

Grip Strength - Hand Dynamometer

时间窗: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion

Grip strength will be measured in kilograms using a hand dynamometer. Continuous scale, higher scores indicate better outcome

Upper Extremity Function - Duruöz Hand Index

时间窗: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion

The Duruöz Hand Index is a functional scale that assesses hand-related disability. Scores range from 0 to 90, with higher scores indicating worse functional impairment.

Functional Evaluation - PRTEE-T (Patient-Rated Tennis Elbow Evaluation)

时间窗: Baseline (Day 1), at the end of 2-week treatment, 4 weeks after treatment completion

The PRTEE-T is a 15-item patient-rated questionnaire for lateral epicondylitis. Total scores range from 0 (no disability) to 100 (maximum disability). Continuous scale (0-100), higher scores indicate worse outcome.

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

Suat EREL

HEAD OF THE DEPARTMENT OF ORTHOPEDIC REHABILITATION

Pamukkale University

研究点 (1)

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