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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tendinopathy

Intervention / Treatment
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* Combination Product: Focused shockwave therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lateral hip pain, worst over the greater trochanter, present for a minimum of 3 months Age 35-70 years Female 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: focused shockwave therapy<br>3 sessions of shock wave treatment.(Focused Shockwave Therapy). | Combination Product: Focused shockwave therapy<br>* 3 session of shockwave therapy. The wave is focused through a standoff and transmitted into the tissue. Enhanced Energy: 0.01 - 0.55mJ/mm2. Broad Frequency Range: 1 - 8Hz. 12.5 cm penetration with pinpoint focus. The patient will be treated in the lateral decubitus position. The shock wave will focus on the area of maximal tenderness, which will be treated in a circumferential pattern.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Rating of Change Scale |  | 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQoL | EQ-5D™ | 0, 12 and 26 weeks follow-up | 
| Muscle strength Static | Hip abduction strength | 0, 12 and 26 weeks follow-up | 
| Pain Pressure Threshold | Lateral hip region | 0, 12 and 26 weeks follow-up | 
| Patient-Specific Functional Scale). | difficulties with 1-5 functional tasks | 0, 6, 12 and 26 weeks follow-up | 
| PHQ9 | Severity of depression | 0, 12 and 26 weeks follow-up | 
| VISA-G | disability score for gluteal tendinopathy | 0, 12 and 26 weeks follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Greater Trochanter Pain Syndrome, Lateral hip pain