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

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.

Study Overview

• Status: Unknown
• Conditions: Tendinopathy
• Intervention / Treatment: Combination product: Focused shockwave therapy

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Aalborg University Hospital
    • Contact: Jens Kristinsson, MD; Email: hjk@rn.dk
    • Contact: Carsten M Molgaard, PhD; Email: cmm@rn.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: focused shockwave therapy; 3 sessions of shock wave treatment.(Focused Shockwave Therapy).

Combination product: Focused shockwave therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: University of Canberra
• Investigators: Principal Investigator: Carsten M Molgaard, PhD, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2018
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Greater Trochanter Pain Syndrome; Lateral hip pain
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: N-20180036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No