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

Not Applicable

• Conditions: Tendinopathy
• Interventions: Combination Product: Focused shockwave therapy

• Registration Number: NCT04058509
• Lead Sponsor: Aalborg University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-28
• Status Verified: 2019-08
• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-14
• Last Update Submitted: 2019-08-14
• Study First Posted: 2019-08-15
• Last Update Posted: 2019-08-15
• Primary Completion: 2019-12-30
• Study Completion: 2020-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
focused shockwave therapy	Focused shockwave therapy	3 sessions of shock wave treatment.(Focused Shockwave Therapy).

Primary Outcome Measures

Name	Time	Method
Global Rating of Change Scale	3 months follow-up

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark