Greater Trochanteric Pain Syndrome Clinical Trial
Official title:
Feasibility of a Home Exercise Program With the Addition of a Corticosteroid Injection in Patients With Greater Trochanteric Pain Syndrome in General Practice
NCT number | NCT05086926 |
Other study ID # | Study3-2021 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2021 |
Est. completion date | February 2022 |
Pain on the lateral side of the hip is a common condition in general practice, however there is limited evidence on how to best manage the condition. The purpose of this study is to evaluate the feasibility of a combined treatment before comparing this treatment in a larger clinical trial. For the present study 20 patients with lateral hip pain will be invited to receive a corticosteroid injection in the lateral hip prior to performing our exercise program for 8 weeks. After 4 weeks we will do a short interview to get feedback on the exercise program. After 8 weeks we will evaluate the acceptability of the combined treament.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | February 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for General Practice at Aalborg University | Aalborg |
Lead Sponsor | Collaborator |
---|---|
Aalborg University |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Qualitative outcomes | Short interview to obtain qualitative feedback from participants. Questions:
How was your experience in general with completing this exercise program? Which challenges did you experience? How did you find the difficulty of the levels in the exercise program? Did you have any challenges with the training diary? Did you find the phone call from the project manager at one week useful? |
4 weeks | |
Primary | Acceptability of performing our exercise program | 7-point Likert scale range "very unacceptable" to "very acceptable" | 8 weeks | |
Primary | Acceptability of performing exercises after receiving a corticosteroid injection | 7-point Likert scale range "very unacceptable" to "very acceptable" | 8 weeks | |
Secondary | Global Rating of Change | This 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". | 4 and 8 weeks | |
Secondary | Patent Acceptable Symptom State | This 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?" | 4 and 8 weeks | |
Secondary | Pain Self-Efficacy Questionnaire | This is a self-reported measure used to assess how confident patients are in performing activities while in pain. The outcome is a score of 0 to 60, with higher score indicating higher self-efficacy. We will use a Danish validated version | 4 and 8 weeks | |
Secondary | Health-related quality of life | We will use EuroQol-5D-5L. This is a standardized instrument to assess health related quality of life. | 4 and 8 weeks | |
Secondary | Compliance to exercises | Participants will record their exercise sessions using an exercise diary | 8 weeks |
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