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

Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04058509
• Other study ID #: N-20180036
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: August 2019
• Source: Aalborg University Hospital
• Contact: Carsten M Molgaard, PhD
• Phone: +4523806882
• Email: cmm[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Tendinopathy

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University Hospital	University of Canberra

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Rating of Change Scale		3 months follow-up
Secondary	EuroQoL	EQ-5D™	0, 12 and 26 weeks follow-up
Secondary	Muscle strength Static	Hip abduction strength	0, 12 and 26 weeks follow-up
Secondary	Pain Pressure Threshold	Lateral hip region	0, 12 and 26 weeks follow-up
Secondary	Patient-Specific Functional Scale).	difficulties with 1-5 functional tasks	0, 6, 12 and 26 weeks follow-up
Secondary	PHQ9	Severity of depression	0, 12 and 26 weeks follow-up
Secondary	VISA-G	disability score for gluteal tendinopathy	0, 12 and 26 weeks follow-up