Self-management Program for Greater Trochanteric Pain Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Victorian Institute of Sport Assessment Gluteal Questionnaire (VISA-G)
研究概览
简要总结
The HIPS-study will be an observer blinded, single-centre, parallel-group randomized controlled trial (RCT).
The main purpose of the study is:
- To investigate the clinical effectiveness of a self- management program versus usual care for patients with greater trochanteric pain syndrome (GTPS).
- H0: There is no difference between a self-management program and usual care on pain and function in patients with GTPS.
- H1: There is a difference between a self-management program and usual care on pain and function in patients with GTPS.
- To investigate if self-management is more cost-effective than usual care in the treatment of patients with GTPS.
Participants will be randomly allocated into one of two groups: 1) self-management program or 2) usual care.
Follow-up will be at 3-, 6- and 12-months.
详细描述
Background:
Continuous or intermittent lateral hip pain, also known as greater trochanteric pain syndrome (GTPS), is a common chronic and disabling musculoskeletal condition. It usually occurs during the fourth to sixth decades of life, predominantly among women. The prevalence and incidence rates have been reported to be 4.2 and 3.3 per 1000 person-years, respectively, in the general practice population. The impact of GTPS is reported to be debilitation, as it typically disturbs sleep and limits daily function and participation in work.
Exercise and education are considered the cornerstone of treatment, and in recent randomized controlled trials this combination has demonstrated significant improvements in pain and function. However, studies have failed to show any difference between specific hip exercises and non-specific (sham) exercises in combination with patient education. As GTPS is recurrent and persistent of nature, person-centered care and the incorporation of self-management strategies could be beneficial. To the investigators knowledge, this study will be the first one to investigate self-management for the current patient population. Results from the study may change the type, delivery, and content of treatment for patients with GTPS, relevant for both primary- and secondary care.
The main objective of the study is to evaluate the clinical effectiveness of a self-management program compared to usual care for patients with GTPS.
Methods and analyses:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants between 18 and 70 years of age
- •History of lateral hip pain > 3 months
- •Reported average pain intensity the last week ≥ 3 on a numeric rating scale
- •Lateral hip pain is the main complaint
- •Pain on palpation of the greater trochanter region
- •In addition, lateral hip pain on at least one of the following tests:
- •Single leg stance test: standing 30 seconds on the affected leg
- •FADER: passive stretch/compression of gluteus medius/minimus
- •FADER-R: static muscle test with resistance to internal hip rotation
- •ADD: passive stretch to hip adduction in sidelying
- •ADD-R: resisted hip abduction in sidelying
- •FABER (Patrick's) test
- •A positive test is defined as a spontaneous reproduction of the participant's lateral hip pain. In participants with bilateral lateral hip pain, the worst hip will be included, and the presence of bilateral pain will be documented.
排除标准
- •Significant back pain causing referred pain to the lateral hip
- •Clinical signs of radiculopathy
- •Symptomatic osteoarthritis
- •Other hip joint pathologies
- •History of trauma or surgery on the affected side
- •Pregnancy or post-partum pelvic pain (under 12 months since birth)
- •Active cancer
- •Not able to write, read, and comprehend Norwegian (without the use of an interpreter)
研究组 & 干预措施
Self-management
The intervention will consist of 3-5 individual sessions over 12 weeks with a physiotherapist.
There will be 3 physiotherapists delivering the self-management intervention.
干预措施: Self-management (Other)
Usual care
Given standardized information at baseline and free to choose further treatment in primary care.
干预措施: Usual care (Other)
结局指标
主要结局
Victorian Institute of Sport Assessment Gluteal Questionnaire (VISA-G)
时间窗: Baseline, 3 months, 6 months, 12 months
Pain and function. Total score ranges from 0-100, with higher scores representing less pain and disability.
次要结局
- Numeric rating scale (NRS)(Baseline, 3 months, 6 months, 12 months)
- Painful sites(Baseline, 3 months, 6 months, 12 months)
- iMTA Medical Consumption Questionnaire (iMCQ)(Baseline, 3 months, 6 months, 12 months)
- iMTA Productivity Cost Questionnaire (iPCQ)(Baseline, 3 months, 6 months, 12 months)
- Expectations on numeric rating scale (NRS)(Baseline, 3 months, 6 months)
- Global rating of change (GROC)(6 months)
- The Pain Self-Efficacy Questionnaire (PSEQ)(Baseline, 3 months, 6 months, 12 months)
- EuroQoL-5 dimensions-5 Level (Eq-5D-5L)(Baseline, 3 months, 6 months, 12 months)
- Hopkins Symptoms checklist-10 (HSCL-10)(Baseline, 3 months, 6 months, 12 months)
- Expectations related to VISA-G(Baseline)
- Patient acceptable symptom state (PASS)(6 months)
研究者
Marianne Bakke Johnsen
Principal investigator
Oslo University Hospital