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

NCT ID: NCT04058509

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-28
• Study Completion Date: 2020-07-30

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.

Conditions

Tendinopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

focused shockwave therapy

3 sessions of shock wave treatment.(Focused Shockwave Therapy).

Group Type: EXPERIMENTAL

Focused shockwave therapy

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Canberra

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Carsten Møller Poulsen Mølgaard

Clinical research physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carsten M Molgaard, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

Aalborg University Hospital

Aalborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Carsten M Molgaard, PhD

Role: CONTACT

cmm@rn.dk

+4523806882

Jens Kristinsson, MD

Role: CONTACT

hjk@rn.dk

Facility Contacts

Carsten M Molgaard, PhD

Role: primary

cmm@rn.dk

Jens Kristinsson, MD

Role: backup

hjk@rn.dk

Other Identifiers

N-20180036

Identifier Type: -

Identifier Source: org_study_id