Feasibility of a Home Exercise Program With the Addition of a Corticosteroid Injection in Patients With Lateral Hip Pain
NCT Number: NCT06456099
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Greater Trochanteric Pain Syndrome
Interventions: DRUG: Ultrasound-guided corticosteroid injection|BEHAVIORAL: Home exercise program|BEHAVIORAL: Patient information leaflet
Sponsor: Aalborg University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-07
Completion Date: 2024-09-30
Locations: Center For General Practice in Aalborg, Gistrup, 9260, Denmark

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.

Primary Outcome Measures: Acceptability of performing our exercise program, This outcomes will be evaluated by asking the participants the following question "How acceptable was it for you to perform the exercise program?". This will be answered using a 7-point Likert scale ranging from "very unacceptable" to "very acceptable". The responses will be dichotomized as either "unacceptable" (category 1-4) or "acceptable" (category 5-7). Participants will be asked to elaborate their responses in a text field. Compliance to exercises will be measured using a training diary., 8-week follow-up|Acceptability of performing exercises after receiving a corticosteroid injection, This outcome will be evaluated by asking the participants the question "How acceptable was it for you to start doing exercises shortly after receiving a corticosteroid injection?". This will be answered using a 7-point Likert scale ranging from "very unacceptable" to "very acceptable". The responses will be dichotomized as either "unacceptable" (category 1-4) or "acceptable" (category 5-7). Participants will be asked to elaborate their responses in a text field., 8-week follow-up|Feasibility of the Home exercise program with the addition of a corticosteroid injection, To conclude that the combined treatments are feasible, ≥ 75% of patients must rate the treatment as 'acceptable'. If any participant drops out after the injection, they will be dichotomized as "not acceptable". A minimum of 15/20 training diaries must be handed in at 8-weeks follow-up. Based on the returned training diaries, ≥ 75% of participants need to complete ≥ 20/28 possible training sessions. A training session will be considered completed if the participant has performed at least one set of each exercise., 8-week follow-up
Secondary Outcome Measures: Exercise motivation, Exercise motivation is assessed using a 5-point Likert scale, Baseline|Global rating of change (GROC), GROC is determined by asking the question "How is your lateral hip pain now compared to when you first came in for treatment in this project?", which will be responded to with a 7-point Likert scale ranging from "very much worse" to "very much better"., 8-week follow-up|Patient Acceptable Symptom State (PASS), PASS will be identified by asking the patient to answer yes or no to the question "Is your lateral hip pain at an acceptable level that does not require any further treatment?" Average of present lateral hip pain intensity over the last week on a numeric rating scale 0-10, 8-weeks follow-up|VISA-G, Question 1 receives a VAS rating of 0 to 10. (10 is optimal health) The 5 categories on questions 2 through 6 can be scored as 0, 2, 5, 7, or 10. The 4 categories on question 7 can be scored as 0, 4, 7, or 10. Question 8 is graded according to how long the patient can train in spite of their current level of pain.

The maximum score for an asymptomatic person is 100; the smallest score is 0, Baseline, 4-weeks and 8-weeks follow-up|Pain Self-Efficacy Questionnaire (PSEQ), Each item is scored on a 7-point scale ranging from 0 (not at all confident) to 6 (completely confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy in managing pain and performing daily activities., Baseline, 4-weeks and 8-weeks follow-up|Health-related quality of life (EQ-5D-5L), The EQ-5D-5L is measured by having patients complete a questionnaire that assesses their health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems. Additionally, patients rate their overall health on a visual analog scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health)., Baseline, 4-week and 8-week follow-up
Other Outcome Measures: Qualitative outcomes, Qualitative data will be obtained via interviews at 4- and 8-week follow-up, in order to get feedback that will help us refine our exercise intervention before we apply it in a larger trial. The interviews will be recorded and transcribed., 4-week and 8-week follow-up