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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04058509
Enrollment
60
Registered
2019-08-15
Start date
2018-11-28
Completion date
2020-07-30
Last updated
2019-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendinopathy

Keywords

Greater Trochanter Pain Syndrome, Lateral hip pain

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.

Interventions

COMBINATION_PRODUCTFocused 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.

Sponsors

University of Canberra
CollaboratorOTHER
Aalborg University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Global Rating of Change Scale3 months follow-up

Secondary

MeasureTime frameDescription
Muscle strength Static0, 12 and 26 weeks follow-upHip abduction strength
Pain Pressure Threshold0, 12 and 26 weeks follow-upLateral hip region
EuroQoL0, 12 and 26 weeks follow-upEQ-5D™
PHQ90, 12 and 26 weeks follow-upSeverity of depression
VISA-G0, 12 and 26 weeks follow-updisability score for gluteal tendinopathy
Patient-Specific Functional Scale).0, 6, 12 and 26 weeks follow-updifficulties with 1-5 functional tasks

Countries

Denmark

Contacts

Primary ContactCarsten M Molgaard, PhD
cmm@rn.dk+4523806882
Backup ContactJens Kristinsson, MD
hjk@rn.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026