Feasibility of a Home Exercise Program With the Addition of a Corticosteroid Injection in Patients With Greater Trochanteric Pain Syndrome in General Practice
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Acceptability of performing our exercise program
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>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
排除标准
- •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
研究组 & 干预措施
Exercises and CSI
A corticosteroid injection in the lateral hip prior to performing an 8-week home exercise program
干预措施: Exercises and CSI (Combination Product)
结局指标
主要结局
Acceptability of performing our exercise program
时间窗: 8 weeks
7-point Likert scale range "very unacceptable" to "very acceptable"
Acceptability of performing exercises after receiving a corticosteroid injection
时间窗: 8 weeks
7-point Likert scale range "very unacceptable" to "very acceptable"
次要结局
- Health-related quality of life(4 and 8 weeks)
- Global Rating of Change(4 and 8 weeks)
- Compliance to exercises(8 weeks)
- Patent Acceptable Symptom State(4 and 8 weeks)
- Pain Self-Efficacy Questionnaire(4 and 8 weeks)
研究者
Sabina Vistrup
MD, PhD student
Aalborg University