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临床试验/NCT07243327
NCT07243327招募中不适用

A Prospective Randomized Controlled Trial Comparing the Effectiveness of Extracorporeal Shockwave Therapy and Conventional Physical Therapy in Patients With Greater Trochanteric Pain Syndrome

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Change in Visual Analog Scale (VAS) Pain Score

研究概览

简要总结

This study aims to compare the effectiveness of Extracorporeal Shockwave Therapy (ESWT) with conventional physical therapy in patients with Greater Trochanteric Pain Syndrome (GTPS). GTPS is a common cause of lateral hip pain, often related to gluteal tendinopathy rather than trochanteric bursitis. Sixty patients will be randomly assigned to two groups: ESWT or conventional physical therapy (TENS, hot pack, ultrasound). Pain (VAS), hip function (Harris Hip Score), lower limb function (LEFS), and global improvement will be evaluated at baseline, week 3, and week 12. The purpose of this study is to determine which treatment provides greater pain relief and functional improvement.

详细描述

Greater Trochanteric Pain Syndrome (GTPS) is a frequent cause of lateral hip pain and is now understood to be primarily associated with gluteus medius and minimus tendinopathy rather than inflammation of the trochanteric bursa. Although several conservative treatments are available, including nonsteroidal anti-inflammatory drugs and physical therapy modalities, there is no consensus on the most effective treatment strategy. Extracorporeal Shockwave Therapy (ESWT) has emerged as a potential non-invasive treatment option that may promote tissue regeneration, reduce pain, and improve tendon healing.

This prospective randomized controlled trial will include 60 patients aged 18-65 years with MRI-confirmed GTPS. Participants will be randomly assigned (1:1) to either the ESWT group or the conventional physical therapy group. The ESWT group will receive five sessions over 3 weeks (15 Hz, 3 bar, 2000 pulses). The physical therapy group will receive 10 sessions of TENS (20 minutes), hot pack (20 minutes), and continuous ultrasound (1.5 W/cm², 5 minutes). Both groups will be given a standardized exercise program.

Outcome measures include the Visual Analog Scale (VAS) for pain (night, rest, activity), Harris Hip Score, Lower Extremity Functional Scale (LEFS), and the Global Rating of Change Scale. Assessments will be performed at baseline, week 3, and week 12. The primary objective is to compare the effect of ESWT versus conventional physical therapy on pain reduction. Secondary objectives include evaluating functional improvements and global patient satisfaction.

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

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 between 18 and 65 years
  • Lateral hip pain for at least 3 months
  • Ability to understand study procedures and provide informed consent

排除标准

  • Hip deformities
  • Gluteus medius, gluteus minimus, or piriformis tendon tears
  • Lumbar radiculopathy or history of lumbar spine surgery
  • Recent trauma or active infection in the hip region
  • Corticosteroid injection to the hip within the last 6 months
  • Neurological, psychiatric, or rheumatologic diseases
  • Active malignancy or systemic inflammatory disease
  • Cognitive impairment preventing cooperation

研究组 & 干预措施

ESWT Group

Experimental

Extracorporeal shockwave therapy applied 5 sessions over 3 weeks (15 Hz, 3 bar, 2000 pulses). Standard hip exercises included.

干预措施: Extracorporeal Shockwave Therapy (ESWT) (Device)

Conventional Physical Therapy Group

Active Comparator

10 sessions of TENS (20 min), hot pack (20 min), and continuous ultrasound (1.5 W/cm², 5 min). Standard hip exercises included.

干预措施: TENS; Hot Pack; Ultrasound (Other)

结局指标

主要结局

Change in Visual Analog Scale (VAS) Pain Score

时间窗: Baseline, Week 3, and Week 12

Pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS) for activity, rest, and night pain. The primary endpoint is the change in VAS score from baseline to Week 12.

次要结局

  • Harris Hip Score(Baseline, Week 3, and Week 12)
  • Lower Extremity Functional Scale (LEFS)(Baseline, Week 3, and Week 12)
  • Global Rating of Change (GROC)(Week 3 and Week 12)

研究者

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

Zeynep Karakuzu Güngör

Kanuni Sultan Suleyman Training and Research Hospital

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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