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

A

Aalborg University Hospital

Status

Unknown

Conditions

Tendinopathy

Treatments

Combination Product: Focused shockwave therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04058509
N-20180036

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

Female

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

focused shockwave therapy
Experimental group
Description:
3 sessions of shock wave treatment.(Focused Shockwave Therapy).
Treatment:
Combination Product: Focused shockwave therapy

Trial contacts and locations

1

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Central trial contact

Jens Kristinsson, MD; Carsten M Molgaard, PhD

Data sourced from clinicaltrials.gov

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