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Comparison of ESWT and Single-Session 5% Dextrose Prolotherapy in Lateral Epicondylitis

2026年5月27日 更新者：Merve Örücü Atar、Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Comparison of the Effectiveness of Extracorporeal Shock Wave Therapy and 5% Dextrose Prolotherapy in Patients With Lateral Epicondylitis: A Prospective Randomized Controlled Trial

Lateral epicondylitis is a common musculoskeletal disorder associated with pain and impaired upper extremity function. The aim of this study was to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and single-session 5% dextrose prolotherapy (DPT) in patients with lateral epicondylitis and to evaluate the relative superiority of these treatment approaches during short- and mid-to-long-term follow-up. Ninety-six patients were allocated into three groups: conventional treatment alone, conventional treatment plus ESWT, and conventional treatment plus DPT. Pain, functional status, grip strength, and common extensor tendon thickness were evaluated during follow-up.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Lateral epicondylitis is a common musculoskeletal disorder associated with pain, reduced grip strength, and impaired upper extremity function. This study aimed to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and single-session 5% dextrose prolotherapy (DPT) in patients with lateral epicondylitis and to evaluate their relative effectiveness during short- and mid-to-long-term follow-up.

Ninety-six patients were allocated into three groups: conventional treatment alone, conventional treatment plus ESWT, and conventional treatment plus DPT. Conventional treatment consisted of home exercise and splinting. ESWT was applied in 3 sessions (2000 pulses, 0.15 mJ/mm²), while the DPT group received a single ultrasound-guided 5% dextrose injection.

Primary outcomes included Visual Analog Scale pain scores for rest, night pain, resisted wrist extension, and grip pain. Secondary outcomes included QuickDASH, PRTEE, grip strength measured with a Jamar dynamometer, and ultrasonographic assessment of common extensor tendon thickness. Clinical assessments were performed at baseline, 1, 3, and 6 months.

研究类型

介入性

注册 (实际的)

96

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 土耳其（türkiye）
    • Cankaya
      • Ankara、Cankaya、土耳其（türkiye）
        • SBU Ankara Physical Medicine and Rehabilitation Training and Research Hospital Ankara, Turkey

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults aged 18-75 years
  • Clinical and ultrasonographic diagnosis of lateral epicondylitis
  • Symptoms persisting for at least 3 months
  • Visual Analog Scale (VAS) score ≥4
  • Resistance to previous medical treatment
  • Ability to comply with study procedures and complete questionnaires

Exclusion Criteria:

  • Injection treatment for lateral epicondylitis within the previous 3 months
  • History of trauma within the previous 3 months
  • Cervical disc herniation
  • Median or ulnar tunnel neuropathy
  • Medial epicondylitis
  • Anticoagulant therapy use
  • Pregnancy or breastfeeding
  • Psychiatric disorders or cognitive impairment interfering with questionnaire -completion
  • Allergy to the treatment solution
  • History of upper extremity surgery or fracture
  • Rheumatoid arthritis
  • Connective tissue diseases such as dermatomyositis

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Conventional Treatment + ESWT
Three treatment sessions administered at weekly intervals using 2000 pulses per session at an energy flux density of 0.15 mJ/mm².
行为的：Conventional Treatment group
Splinting and home exercise program
设备：Extracorporeal Shock Wave Therapy (ESWT)
3 sessions, weekly, 4Hz, 2000 pulses/session, 0.15 mJ/mm².
有源比较器：Conventional Treatment + Dextrose Prolotherapy
Single-session ultrasound-guided injection of 1 mL 5% dextrose.
行为的：Conventional Treatment group
Splinting and home exercise program
程序：Dextrose prolotherapy (DPT)
Single-session ultrasound-guided 1 mL 5% dextrose injection.
有源比较器：Conventional Treatment
Splinting and home exercise program.
行为的：Conventional Treatment group
Splinting and home exercise program

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
VAS Resisted Wrist Extension Pain
大体时间：Baseline, 1 month, 3 months, and 6 months after treatment
Pain during resisted wrist extension assessed using the Visual Analog Scale (VAS).
Baseline, 1 month, 3 months, and 6 months after treatment
VAS Gripping Pain
大体时间：Baseline, 1 month, 3 months, and 6 months after treatment
Pain intensity during gripping assessed using the Visual Analog Scale (VAS).
Baseline, 1 month, 3 months, and 6 months after treatment
VAS Resting Pain
大体时间：Baseline, 1 month, 3 months, and 6 months after treatment
Resting pain assessed using the Visual Analog Scale (VAS).
Baseline, 1 month, 3 months, and 6 months after treatment
VAS Night Pain
大体时间：Baseline, 1 month, 3 months, and 6 months after treatment
Night pain assessed using the Visual Analog Scale (VAS).
Baseline, 1 month, 3 months, and 6 months after treatment

次要结果测量

结果测量
措施说明
大体时间
Quick-DASH Score
大体时间：Baseline, 1 month, 3 months, and 6 months after treatment
Functional disability assessed using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire. The QuickDASH score ranges from 0 to 100, where 0 indicates no symptoms and normal upper extremity function, while 100 indicates the highest symptom severity and the poorest functional status.
Baseline, 1 month, 3 months, and 6 months after treatment
PRTEE Score
大体时间：Baseline, 1 month, 3 months, and 6 months after treatment
Functional outcome assessed using the Patient-Rated Tennis Elbow Evaluation questionnaire. The PRTEE consists of 15 items divided into two subscales: pain (5 items) and function (10 items). The total score ranges from 0 to 100, with 0 indicating no pain and normal function, and 100 indicating the highest pain severity and the poorest functional status. Higher scores reflect greater pain intensity and functional impairment.
Baseline, 1 month, 3 months, and 6 months after treatment
Grip Strength
大体时间：Baseline and 6 months
Grip strength measured using a Jamar dynamometer.
Baseline and 6 months
Common Extensor Tendon Thickness
大体时间：Baseline and 6 months
Ultrasonographic measurement of common extensor tendon thickness.
Baseline and 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年10月1日

初级完成 (实际的)

2025年8月29日

研究完成 (实际的)

2025年8月29日

研究注册日期

首次提交

2026年5月27日

首先提交符合 QC 标准的

2026年5月27日

首次发布 (实际的)

2026年6月2日

研究记录更新

最后更新发布 (实际的)

2026年6月2日

上次提交的符合 QC 标准的更新

2026年5月27日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • E1-23-4037

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be publicly shared due to institutional and ethical restrictions regarding patient confidentiality.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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