NCT04058509

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

August 14, 2019

Last Update Submit

August 14, 2019

Conditions

Tendinopathy

Keywords

Greater Trochanter Pain SyndromeLateral hip pain

Outcome Measures

Primary Outcomes (1)

  • Global Rating of Change Scale

    3 months follow-up

Secondary Outcomes (6)

  • EuroQoL

    0, 12 and 26 weeks follow-up

  • Muscle strength Static

    0, 12 and 26 weeks follow-up

  • Pain Pressure Threshold

    0, 12 and 26 weeks follow-up

  • Patient-Specific Functional Scale).

    0, 6, 12 and 26 weeks follow-up

  • PHQ9

    0, 12 and 26 weeks follow-up

  • +1 more secondary outcomes

Study Arms (1)

focused shockwave therapy

EXPERIMENTAL

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

Combination Product: Focused shockwave therapy

Interventions

Focused shockwave therapyCOMBINATION_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.

focused shockwave therapy

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Study Officials

  • Carsten M Molgaard, PhD

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carsten M Molgaard, PhD

CONTACT

+4523806882cmm@rn.dk

Jens Kristinsson, MD

CONTACT

hjk@rn.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical research physiotherapist

Study Record Dates

First Submitted

August 14, 2019

First Posted

August 15, 2019

Study Start

November 28, 2018

Primary Completion

December 30, 2019

Study Completion

July 30, 2020

Last Updated

August 15, 2019

Record last verified: 2019-08

Locations

DK(1)