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临床试验/NCT06584500
NCT06584500尚未招募不适用

Analysis of the Effect of Dry Needling on the Pelvitrochanteric Musculature on the Potential Contraction of the Gluteus Medius in Patients with Greater Trochanteric Pain Syndrome: Protocol for a Randomized Clinical Trial. Pilot Study

University of Alcala1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Potential Contraction with M-Mode

研究概览

简要总结

Grater trochanteric pain syndrome is a hip related pathology that causes lateral hip pain and lack of strength in abductor muscles such as the gluteus medius, which hinders functional activities and daily life, such as standing, walking, sleeping on the affected side... Lack of strength and eccentric control of the gluteus medius may be related to the apparition of myofascial trigger points that are susceptible to treatment with dry needling.

In this study, two groups of patients with greater trochanteric pain syndrome will be treated with dry needling, some of them with real dry needling, and others with sham dry needling. Ultrasound will be used to assess whether real dry needling in the pelvitrochanteric musculature improves the potential contraction of the gluteus medius, in relation to a baseline measurement and to sham dry needling.

This study is a randomised clinical trial protocol, pilot study, so there will be no previous references for the sample of both study groups. 3 dry needling interventions will be performed in 3 consecutive weeks, leaving 1 week between each intervention. Data will be collected for the variables to be investigated (potential contraction, pain, function, strength…) before the first intervention, after each intervention, 1 month after the last intervention and at 3 months.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lateral hip pain lasting more than 3 months.
  • Greater trochanteric pain syndrome compatible with changes on MRI.
  • Clinical examination correlation: one of the following tests must be positive: FADER test, FABER test, hip adduction (ADD) test in side-lying position (DL), isometric contraction test in the ADD position, or single-leg stance test for 30 seconds.
  • Pain/sensitization upon palpation of the trochanter.

排除标准

  • Radicular pain due to lumbar pathology.
  • Osteoarthritis.
  • Pelvic pathology that could refer pain to the hip.
  • Needle phobia.
  • Hip injection performed less than 6 months ago.
  • Dry needling performed less than 1 month ago.
  • Surgery or pathology of the lower limb that prevents single-leg support.
  • Systemic diseases that could interfere with the pathological process.

结局指标

主要结局

Potential Contraction with M-Mode

时间窗: From enrollment to the end of treatment at 4 months

The primary variable in this study will measure the potential contraction of the gluteus medius. This variable will be assessed using a Sonoscape E2 ultrasound machine with a 5 cm linear probe and the highest scanning speed. The probe will be positioned at the midpoint of the line connecting the anterior and posterior superior iliac spines. In longitudinal scanning, M-mode will be placed cranially to the hip joint capsule. Thickness will be measured from the inner surface of the fascial borders, with the unit of measurement in millimeters (mm). The contraction potential will be the difference between the thickness of the gluteus medius at rest and the thickness at 80% of the maximum voluntary isometric contraction.

次要结局

  • WOMAC hip scale(From enrollment to the end of treatment at 4 months)
  • Hip Abduction Strength(From enrollment to the end of treatment at 4 months)
  • Pain(From enrollment to the end of treatment at 4 months)
  • Passive Hip Range of Motion(From enrollment to the end of treatment at 4 months)

研究者

发起方
University of Alcala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Teresa Suárez del Villar Estéfano

María Teresa Suárez del Villar Estéfano

University of Alcala

研究点 (1)

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