Clinical trial NCT05086926: Feasibility of Home Exercises With the Addition of a Corticosteroid Injection in Patients With Lateral Hip Pain in General Practice
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lateral Hip Pain
Gluteal Tendinopathy
Greater Trochanteric Pain Syndrome
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: BACKGROUND:

Lateral hip pain or greater trochanteric pain syndrome (GTPS) is pain on the outside of the hip due to tendon pathology of the hip abductor tendons. The incidence in primary care has been reported to be 1.6-3.3 per 1000 patients per year. At present, there is no evidence-based guidelines for the treatment of GTPS in primary care. The investigators of the present study have developed an exercise protocol that is planned be evaluated in a future randomized controlled trial in combination with a corticosteroid injection.

OBJECTIVE:

The purpose of this study is to evaluate feasibility of a home exercise program with the addition of a corticosteroid injection in patients with GTPS in general practice. The primary aim is to evaluate patient acceptability of 1) performing our exercise program 2) performing exercises after receiving a corticosteroid injection. The secondary aim is to obtain feedback from patients through qualitative interviews to be able to refine the exercise intervention after the study is completed. If the combined treatment is found feasible, it is planned to evaluate the effect in a large randomized controlled trial in the future.

STUDY DESIGN:

The study design is a mixed methods feasibility study. The participants are patients with GTPS that will receive a combined treatment of one corticosteroid injection in the lateral hip and a home exercise program, which is to be performed for a period of eight weeks. The acceptability of the combined intervention will be evaluated after 8 weeks.

RECRUITMENT OF PARTICIPANTS:

Patients with GTPS will be recruited from general practice and a private rheumatology practice. Patients will be considered for inclusion if they present to their practitioner with self-reported lateral hip pain. The project manager will make a screening of eligibility by telephone. Those not excluded based on this screening, will be invited to a clinical examination where final eligibility is determined.

ENDPOINTS:

Baseline is at the clinical examination. One week from baseline there will be a short phone contact to the participants in order to clarify any questions related to the exercise program. No data will be obtained at this point. At 4 weeks there will be a phone interview which also serves as a booster session where the participants are encouraged to maintain their exercise routine. At 8 weeks there will be a physical visit where the participants will hand in their exercise diaries and complete the final questionnaires.

CRITERIA OF FEASIBILITY:

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.

In case the combined treatments do not prove feasible according to this set of criteria, it is planned to refine the intervention based on feedback from the interviews and evaluate with a small group of patients for a shorter period of time.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of performing our exercise program
timeFrame: 8 weeks
measure: Acceptability of performing exercises after receiving a corticosteroid injection
timeFrame: 8 weeks
Secondary outcomes:
measure: Global Rating of Change
timeFrame: 4 and 8 weeks
measure: Patent Acceptable Symptom State
timeFrame: 4 and 8 weeks
measure: Pain Self-Efficacy Questionnaire
timeFrame: 4 and 8 weeks
measure: Health-related quality of life
timeFrame: 4 and 8 weeks
measure: Compliance to exercises
timeFrame: 8 weeks
Other outcomes:
measure: Qualitative outcomes
timeFrame: 4 weeks
Locations:
city: Aalborg
country: Denmark
facility: Center for General Practice at Aalborg University
Study officials:
References: