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

Primary Purpose

Tendinopathy

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Focused shockwave therapy
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring Greater Trochanter Pain Syndrome, Lateral hip pain

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Aalborg University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

focused shockwave therapy

Arm Description

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

Outcomes

Primary Outcome Measures

Global Rating of Change Scale

Secondary Outcome Measures

EuroQoL
EQ-5D™
Muscle strength Static
Hip abduction strength
Pain Pressure Threshold
Lateral hip region
Patient-Specific Functional Scale).
difficulties with 1-5 functional tasks
PHQ9
Severity of depression
VISA-G
disability score for gluteal tendinopathy

Full Information

First Posted
August 14, 2019
Last Updated
August 14, 2019
Sponsor
Aalborg University Hospital
Collaborators
University of Canberra
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1. Study Identification

Unique Protocol Identification Number
NCT04058509
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
University of Canberra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
Greater Trochanter Pain Syndrome, Lateral hip pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
focused shockwave therapy
Arm Type
Experimental
Arm Description
3 sessions of shock wave treatment.(Focused Shockwave Therapy).
Intervention Type
Combination Product
Intervention Name(s)
Focused shockwave therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global Rating of Change Scale
Time Frame
3 months follow-up
Secondary Outcome Measure Information:
Title
EuroQoL
Description
EQ-5D™
Time Frame
0, 12 and 26 weeks follow-up
Title
Muscle strength Static
Description
Hip abduction strength
Time Frame
0, 12 and 26 weeks follow-up
Title
Pain Pressure Threshold
Description
Lateral hip region
Time Frame
0, 12 and 26 weeks follow-up
Title
Patient-Specific Functional Scale).
Description
difficulties with 1-5 functional tasks
Time Frame
0, 6, 12 and 26 weeks follow-up
Title
PHQ9
Description
Severity of depression
Time Frame
0, 12 and 26 weeks follow-up
Title
VISA-G
Description
disability score for gluteal tendinopathy
Time Frame
0, 12 and 26 weeks follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carsten M Molgaard, PhD
Phone
+4523806882
Email
cmm@rn.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Kristinsson, MD
Email
hjk@rn.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carsten M Molgaard, PhD
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carsten M Molgaard, PhD
Email
cmm@rn.dk
First Name & Middle Initial & Last Name & Degree
Jens Kristinsson, MD
Email
hjk@rn.dk

12. IPD Sharing Statement

Learn more about this trial

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

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