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临床试验/NCT04058509
NCT04058509Unknown不适用

Clinical Predictors of Extracorporal Shockwave Therapy Efficacy in Patients Presenting With Lateral Hip Pain

Aalborg University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Global Rating of Change Scale

研究概览

简要总结

This pragmatic clinical trial is considering the variable response to treatment outcome of individuals with Greater Trochanteric Pain Syndrome (GTPS). The aim of this study is to identify predictors of focused extracorporeal shockwave therapy (fESWT) efficacy in individuals with GTPS. Specifically, the ability of clinically applicable measurements including: Patient demographics, co-morbidity, oestrogen levels, pain characteristics, hip abductor strength, time to pain during single-leg stance test, low back pain, and immediate pain reduction to local anaesthetic injection at the trochanter major insertion of Gluteus medius (GMed) during walking.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Lateral hip pain, worst over the greater trochanter, present for a minimum of 3 months
  • Age 35-70 years
  • Pain at an average intensity of ≥3 out of 10 on most days of the last week.
  • Tenderness on palpation of the greater trochanter
  • Pain on one of the following:
  • Reproduction of pain on 30 sec single leg stand OR Positive Faber test

排除标准

  • Any known advanced hip joint pathology where groin pain is the primary complaint and/or reproduction of groin pain with Faber or FADDIR.
  • Where range of pure hip joint flexion is <90°
  • Radiating pain distal to the Gluteus Max + positive Straight Leg Raise (SLR-test < 30°)
  • Known advanced knee pathology or restricted range of knee motion (must have minimum 90° flexion and full extension)
  • Any systemic diseases affecting the muscular or nervous system, and uncontrolled diabetes
  • Malignant tumour OR Systemic inflammatory disease
  • Any factors that would preclude the participant from having an MRI (e.g. pacemaker, metal implants, pregnancy, claustrophobia)
  • If the participant is involved in a legal/workcover or other injury claim
  • Fear of needles (trypanophobia)
  • If the participant is unable to write, read or comprehend Danish

结局指标

主要结局

Global Rating of Change Scale

时间窗: 3 months follow-up

次要结局

  • PHQ9(0, 12 and 26 weeks follow-up)
  • VISA-G(0, 12 and 26 weeks follow-up)
  • Patient-Specific Functional Scale).(0, 6, 12 and 26 weeks follow-up)
  • Pain Pressure Threshold(0, 12 and 26 weeks follow-up)
  • EuroQoL(0, 12 and 26 weeks follow-up)
  • Muscle strength Static(0, 12 and 26 weeks follow-up)

研究者

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

Carsten Møller Poulsen Mølgaard

Clinical research physiotherapist

Aalborg University Hospital

研究点 (2)

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