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Comparing Standard Care Approaches for Greater Trochanteric Pain Syndrome in General Practice

2026年9月29日 更新者:Malene Kjær Bruun

Comparing Standard Care Approaches for Greater Trochanteric Pain Syndrome in General Prac-tice: A Randomised Clinical Trial

Pain on the outside of the hip, known as greater trochanteric pain syndrome (GTPS), is a common problem. It is caused by irritation of the tendons that attach the buttock muscles to the hip bone. The condition most often affects middle-aged women and makes everyday activities such as walking, climbing stairs, sitting and lying on the painful side difficult. Many people continue to have pain for years. Today, there is no agreed treatment approach for GTPS in general practice, and it is unclear which of the treatments commonly used works best.

This study compares three treatments that are all already used in Danish healthcare. Participants are adults aged 35 or older who have had pain on the outside of the hip for at least 12 weeks and who show typical signs of GTPS on a clinical examination. An ultrasound scan of the hip is performed to rule out a torn tendon. In total, 192 participants will be recruited, mainly through general practice, and also through specialist clinics, a hospital sports medicine department and social media.

Participants are assigned by chance (randomised) to one of three groups:

  1. Advice: a leaflet explaining the condition and how to manage daily activities, with a brief verbal explanation.
  2. Advice plus home exercises: the leaflet plus three simple strength exercises done at home three times a week, with written instructions, online videos and an exercise diary.
  3. Advice plus home exercises plus a steroid injection: the same as group 2, plus a cortisone injection given with ultrasound guidance into the painful area of the hip within a week of the first visit. The injection can be repeated once after 6 weeks if pain persists.

The main question is how many participants in each group feel much better after 3 months. Participants also answer questions about pain, hip function, quality of life, physical activity, exercise adherence, side effects and use of healthcare. Questionnaires are completed online after 1, 2, 3, 6 and 12 months, and participants attend three visits with a clinical examination and ultrasound scan: at the start, after 6 weeks and after 3 months.

The study takes place at two sites in Denmark: Bispebjerg Hospital in Copenhagen and the Research Unit for General Practice in Aalborg. We expect that adding exercises, and adding exercises and an injection, will lead to greater improvement than advice alone. The results will help guide treatment of GTPS in general practice.

研究概览

研究类型

介入性

注册 (估计的)

192

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。

学习联系方式

研究联系人备份

学习地点

      • Gistrup、丹麦、9260
        • Forskningsenheden for Almen Praksis i Aalborg
        • 接触:
      • København NV、丹麦、2400
        • Institut for idrætsmedicin, Bispebjerg og Frederiksberg Hospital
        • 接触:

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

35年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. 35+ years of age .

  2. Self-reported lateral hip pain for at least 12 weeks, with an average intensity (when pain is present) of at least 4/10 over the past week on a Numeric Rating Scale (NRS, 0-10; 0 = no hip pain, 10 = worst imaginable hip pain).

  3. Access to a computer, smartphone, or tablet with an internet connection.

  4. Tenderness on palpation of the greater trochanter AND at least one of the following:

    1. Reproduction of lateral hip pain with a 30-sec single-leg stance test.
    2. Reproduction of lateral hip pain with the test Flexion, Adduction and External Rotation with Resistance (FADER-R).
  5. Ability to speak and understand Danish (written and oral).

Exclusion Criteria:

  1. Corticosteroid injection in the affected hip within the last 6 months.
  2. History of systemic inflammatory diseases, e.g., rheumatoid arthritis, spondylarthritis.
  3. Weekly intake of oral glucocorticoids.
  4. Individuals with diabetes characterised by unstable or inadequately controlled blood glucose levels (e.g., due to recent medication adjustments or unstable pharmacological management) will be excluded.
  5. Received any treatment by a healthcare professional for GTPS within the previous 12 weeks or made any substantial changes to usual self-management of the condition in the last 4 weeks (eg, started performing stretching, made a substantial decrease in physical activity level).
  6. History of prior hip or lumbar back surgery.
  7. Current low back pain (>5 NRS) or episodes of low back pain within the last 3 months that have caused sick leave and/or treatment by a health professional.
  8. Physical or mental disabilities that make it impossible to understand and perform exercises and complete questionnaires.
  9. Current or planned pregnancy or breastfeeding.
  10. Rupture of gluteal tendon identified on ultrasound.

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:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Patient advice

Patient information leaflet on GTPS and load management, handed out at baseline with brief oral information.

Participants receive a patient information leaflet describing the GTPS condition and emphasising self-management, particularly load management. The leaflet is based on material from a recent randomised trial (the LEAP trial), translated into Danish and adapted to a Danish context through input from clinicians and patients with GTPS. At baseline, the leaflet is handed out together with a brief verbal summary of the key points. A follow-up phone call is made approximately one week after baseline to address any questions regarding the assigned intervention

实验性的:Patient advice + exercise

Patient information leaflet plus a home exercise programme (hip bridge, hip abduction, squat) performed three times a week, with written instructions, online videos and a training diary.

Participants receive a patient information leaflet describing the GTPS condition and emphasising self-management, particularly load management. The leaflet is based on material from a recent randomised trial (the LEAP trial), translated into Danish and adapted to a Danish context through input from clinicians and patients with GTPS. At baseline, the leaflet is handed out together with a brief verbal summary of the key points. A follow-up phone call is made approximately one week after baseline to address any questions regarding the assigned intervention

Participants receive a home-based strength exercise programme in addition to the patient information leaflet. The programme consists of three body-weight exercises (hip bridge, hip abduction and squat) to be performed three times per week. At baseline, participants receive a brief standardised verbal introduction of approximately 10 minutes covering key exercises, technique and progression principles. Written instructions with pictures, access to online instruction videos and a training diary are also provided. Participants are instructed to continue exercising until they reach a personally acceptable symptom level, and for an additional four weeks thereafter. Exercise adherence is monitored using the training diary. A follow-up phone call is made approximately one week after baseline to address any questions regarding the exercise programme.

实验性的:Patient advice + exercise + corticosteroid injection

Patient information leaflet and home exercise programme plus an ultrasound-guided corticosteroid injection at the gluteal tendon insertion no later than 7 days after baseline, with optional repeat injection at 6 weeks if NRS >4.

Participants receive a patient information leaflet describing the GTPS condition and emphasising self-management, particularly load management. The leaflet is based on material from a recent randomised trial (the LEAP trial), translated into Danish and adapted to a Danish context through input from clinicians and patients with GTPS. At baseline, the leaflet is handed out together with a brief verbal summary of the key points. A follow-up phone call is made approximately one week after baseline to address any questions regarding the assigned intervention

Participants receive a home-based strength exercise programme in addition to the patient information leaflet. The programme consists of three body-weight exercises (hip bridge, hip abduction and squat) to be performed three times per week. At baseline, participants receive a brief standardised verbal introduction of approximately 10 minutes covering key exercises, technique and progression principles. Written instructions with pictures, access to online instruction videos and a training diary are also provided. Participants are instructed to continue exercising until they reach a personally acceptable symptom level, and for an additional four weeks thereafter. Exercise adherence is monitored using the training diary. A follow-up phone call is made approximately one week after baseline to address any questions regarding the exercise programme.

Participants receive an ultrasound-guided corticosteroid injection (1 ml triamcinolone 40 mg/ml and 1 ml lidocaine 10 mg/ml) at the insertion of the gluteal tendons on the greater trochanter of the affected hip, administered by a specialist in rheumatology no later than 7 days after the baseline visit. If pain persists at the 6-week follow-up (NRS >4), a repeat injection may be offered. Participants are instructed to begin the exercise programme the day after the injection or as soon as any post-injection pain flare has resolved.

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
Global Rating of Change (GROC)
大体时间:3 months

Proportion of participants reporting "much better" or "very much better" on the GROC, a 7-point scale ranging from "very much worse" to "very much better"

3 months

次要结果测量

结果测量
措施说明
大体时间
Numeric Rating Scale (NRS) - average hip pain
大体时间:1, 2, 3, 6 and 12 months

Self-reported average hip pain intensity over the previous week on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity.

1, 2, 3, 6 and 12 months
Numeric Rating Scale (NRS) - night pain
大体时间:1, 2, 3, 6 and 12 months

Self-reported worst experienced night pain over the previous week on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity.

1, 2, 3, 6 and 12 months
Percentage of time in pain
大体时间:1, 2, 3, 6 and 12 months

Self-reported percentage of time pain has been present during the previous week, ranging from 0% (no time in pain) to 100% (in pain at all times). Higher scores indicate more time spent in pain.

1, 2, 3, 6 and 12 months
Victorian Institute of Sports Assessment for Gluteal Tendons (VISA-G)
大体时间:1, 2, 3, 6, 12 months

Self-reported hip-related disability measured on a scale ranging from 0 to 100. Higher scores indicate better function and less pain.

1, 2, 3, 6, 12 months
Patient Specific Functional Scale (PSFS)
大体时间:1, 2, 3, 6, 12 months

Self-reported functional level for up to five patient-selected activities, each rated on a scale from 0 (unable to perform) to 10 (able to perform at pre-injury level). A mean score is calculated across activities. Higher scores indicate better function.

1, 2, 3, 6, 12 months
Pain Self-Efficacy Questionnaire (PSEQ)
大体时间:1, 2, 3, 6, 12 months

Self-reported confidence in performing activities while in pain, measured on a scale ranging from 0 to 60. Higher scores indicate greater pain self-efficacy.

1, 2, 3, 6, 12 months
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
大体时间:1, 2, 3, 6, 12 months

Health-related quality of life measured as a utility score ranging from -0.624 (worst imaginable health) to 1 (best imaginable health), calculated using Danish population preference weights, and a visual analogue scale ranging from 0 (worst imaginable health) to 100 (best imaginable health). For both calculations, a higher scores indicates better health.

1, 2, 3, 6, 12 months
International Physical Activity Questionnaire (IPAQ)
大体时间:1, 2, 3, 6, 12 months

Self-reported physical activity level expressed as MET-minutes per week, calculated as MET level multiplied by minutes and days per week. Higher scores indicate greater physical activity.

1, 2, 3, 6, 12 months
Patient Acceptable Symptom State (PASS)
大体时间:1, 2, 3, 6, 12 months

Proportion of participants reporting a symptom level acceptable enough not to require further treatment. Participants are considered to have achieved PASS if they answer "yes" to the question "Is your lateral hip pain at an acceptable level that does not require any further treatment?" Time to first PASS will also be recorded.

1, 2, 3, 6, 12 months

其他结果措施

结果测量
措施说明
大体时间
Common Terminology Criteria for Adverse Events (CTCAE v5.0)
大体时间:Baseline through 12 months

Number of participants with adverse events graded by type, severity and causality. Severity is graded on a scale from 1 (mild) to 5 (death).

Baseline through 12 months
Health economic outcomes
大体时间:Baseline through 12 months

Healthcare utilisation, productivity losses and out-of-pocket expenses captured via patient-reported questionnaires, including a modified version of the Oslo Cost Questionnaire (OCC-Q). Quality-adjusted life years (QALYs) calculated from EQ-5D-5L responses using Danish population preference weights, summarised at societal and healthcare system level.

Baseline through 12 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。

调查人员

  • 首席研究员:Finn E Johannsen、Bispebjerg 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 (估计的)

2026年9月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2028年9月1日

研究注册日期

首次提交

2026年9月16日

首先提交符合 QC 标准的

2026年9月29日

首次发布 (实际的)

2026年9月30日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

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

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