Feasibility of a Home Exercise Program With the Addition of a Corticosteroid Injection in Patient… (NCT06456099) | Clinical Trial Compass
RecruitingNot Applicable
Feasibility of a Home Exercise Program With the Addition of a Corticosteroid Injection in Patients With Lateral Hip Pain
Denmark20 participantsStarted 2024-06-07
Plain-language 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.
Who can participate
Age range
35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 35 years of age
* Self-reported pain on the outside of the hip for at least 12 weeks with an average intensity of present pain over the last week of at least 4/10 on a numeric rating scale 0-10 (0 being no hip pain and 10 being worst hip pain imaginable)
* Access to a computer, smartphone or tablet with internet connection
* Tenderness on palpation of the greater trochanter
* Reproduction of lateral hip pain with 30 sec single leg stance test
* Ability to speak and understand Danish (written and oral)
* In case of bilateral hip pain, the study hip will be the most painful at inclusion
Exclusion Criteria:
* Corticosteroid injection in the affected hip or other new treatment by a health professional within the last 3 months
* History of systemic inflammatory diseases, e.g. rheumatoid arthritis, spondyloarthritis
* Weekly intake of oral glucocorticoids
* History of other hip conditions, e.g. clinically significant hip osteoarthritis, hip dysplasia, prior hip surgery
* History of prior lumbar back surgery
* Current low back pain or episodes of low back pain within the last 3 months that have caused sick leave and/or treatment by a health professional
* Physical or mental disabilities that make it impossible to understand and/or perform exercises and complete questionnaires
* Current or planned pregnancy or breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acceptability of performing our exercise program
Timeframe: 8-week follow-up
2
Acceptability of performing exercises after receiving a corticosteroid injection
Timeframe: 8-week follow-up
3
Feasibility of the Home exercise program with the addition of a corticosteroid injection