Clinical trial NCT04058509: Clinical Predictors of Extracorporal Shockwave Therapy Efficacy in Patients Presenting With Lateral Hip Pain
Official title: Clinical Predictors of Extracorporal Shockwave Therapy Efficacy in Patients Presenting With Lateral Hip Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tendinopathy
Keywords: Greater Trochanter Pain Syndrome
Lateral hip pain
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: University of Canberra
First posted: 2019-08-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Global Rating of Change Scale
timeFrame: 3 months follow-up
Secondary outcomes:
measure: EuroQoL
timeFrame: 0, 12 and 26 weeks follow-up
measure: Muscle strength Static
timeFrame: 0, 12 and 26 weeks follow-up
measure: Pain Pressure Threshold
timeFrame: 0, 12 and 26 weeks follow-up
measure: Patient-Specific Functional Scale).
timeFrame: 0, 6, 12 and 26 weeks follow-up
measure: PHQ9
timeFrame: 0, 12 and 26 weeks follow-up
measure: VISA-G
timeFrame: 0, 12 and 26 weeks follow-up
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Carsten M Molgaard, PhD
role: PRINCIPAL_INVESTIGATOR
References: