Feasibility of a Home Exercise Program With the Addition of a Corticosteroid Injection in Patients With Lateral Hip Pain

NCT06456099 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-06-13

No results posted yet for this study

Summary

We have developed an exercise protocol that we plan to evaluate in a future randomized controlled trial in combination with a corticosteroid injection. In accordance with the MRC Framework of Complex Interventions, which reccomends stepwise development of interventions and testing of feasibility before applying them to a trial, we aim to evaluate the feasibility of our intervention before initiating further trials.

The purpose of this non-randomized feasibility study is to test the feasibility and acceptability of this exercise protocol with addition of a corticosteroid injection with no aim of evaluating effects.

All participants in this study will receive the following interventions:

* An ultrasound-guided corticosteroid injection superficial to the insertion of the gluteus medius and minimus tendons on the greater trochanter of the hip.
* A home exercise program including 3 exercises, scalable to 3 different difficulty levels.
* A patient information leaflet containing relevant information on managing lateral hip pain.

Conditions

  • Greater Trochanteric Pain Syndrome

Interventions

DRUG

Ultrasound-guided corticosteroid injection

Participants will receive one ultrasound-guided injection with 1 ml Kenalog 40mg/ml and 1 ml Lidocaine 10mg/ml superficial to the insertion of the gluteus medius and minimus tendons on the greater trochanter of the hip at baseline, Prior to the beginning of exercises.

BEHAVIORAL

Home exercise program

Our exercise protocol is based on previous literature and expert opinions that has been synthesized in a Delphi study conducted by our research group. The exercise program consists of three body weighted strength exercises, that are to be performed every second day for a period of eight weeks (see appendix 6, "Træningsvejledning"). Exercise instructions will be available as a handout and online with video instructions. The corticosteroid injection usually causes a flare-up in pain with a duration of up to 48 hours. Participants will be instructed to begin the exercises as soon as possible after this flare-up has settled. Compliance to exercises are measured using a training diary that the participants must fill out during the study period (see appendix 7, "Træningsdagbog").

BEHAVIORAL

Patient information leaflet

In order to support self-management and modification of tendon load, participants will receive a handout at baseline that contains information about GTPS and advice on load management (see appendix 8, "Folder - Smerter på ydersiden af hoften"). The participants will be encouraged to read the leaflet regularly and follow the advice.

Sponsors & Collaborators

  • Aalborg University

    lead OTHER

Principal Investigators

  • Malene K Bruun, M.Sc. · Research Unit for General Practice in Aalborg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-07
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06456099 on ClinicalTrials.gov