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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04058509
Other study ID # N-20180036
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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