Effectiveness of a 6-month Home-based Exercise Program for Treating Shoulder Instability in Patients With Hypermobile Ehlers-Danlos Syndrome (hEDS) or Hypermobility Spectrum Disorder (HSD): A Pilot Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Western Ontario Shoulder Instability Index (WOSI)
研究概览
简要总结
For hEDS or HSD patients with MDI, a multidisciplinary treatment approach is suggested. As follows, physiotherapy plays a key role in this integrative management. Nevertheless, knowledge regarding EDS is limited among health care professionals. Consequently, evidence-based treatment approaches for the hEDS/HSD population are scarce. Therefore, the aim of this study is to compare two different home-based exercise programs in order to increase our knowledge regarding treatment options, and to gain insight in safe, effective exercises for the unstable shoulder in this study population.
详细描述
The main purpose of this study was to evaluate the value of two telerehabilitation exercise programs for treating multidirectional shoulder instability (MDI) in patients diagnosed with the hypermobile type of The Ehlers-Danlos syndrome (hEDS) or Hypermobility Spectrum Disorders (HSD). Patients were randomly assigned to either the control group (B: evidence-based tailored care) or the experimental group (A: evidence-based standard care). Both groups received a home-based exercise program of 24 weeks. The primary outcome measure was the Western Ontario Shoulder Index (WOSI). Secondary outcomes included the Disabilities of the Arm, Shoulder and Hand (DASH), Tampa Scale for Kinesiophobia (TSK), Patient-Specific Functional Scale (PSFS), Global Rating of Change (GROC), and pain pressure thresholds (PPTs). Outcomes were assessed at baseline, after 6 weeks, 12 weeks, and at the end of the study (24 weeks).
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-65 years
- •Patients diagnosed by a medical doctor with generalized HSD or hEDS, according to the diagnostic criteria for hEDS and HSD as stated in the recently published international classification for the Ehlers-Danlos syndromes
- •Patients diagnosed with multidirctional shoulder instability (MDI): The diagnosis of MDI was confirmed when 1) patients reported symptoms of shoulder instability in daily life (e.g. recurrent subluxations) without a traumatic onset; 2) patients scored positive on shoulder laxity and instability tests (i.e. sulcus sign, anterior and posterior load and shift, posterior jerk, Gagey hyperabduction test, passive and active external rotation in supine, apprehension and relocation test) in at least two directions; 3) patients had shoulder pain for at least three months prior to the study.
排除标准
- •pregnancy during study participation
- •patients who started a new physiotherapeutic treatment in the 2 weeks prior to the study
研究组 & 干预措施
Evidence-based tailored care (group A)
Patients who were randomized to group A received a tailored exercise program, with exercises developed based on recent hEDS/HSD research data.
干预措施: Tailored home-based exercise therapy (Other)
Evidence-based standard care (group B)
This exercise program was composed in order to reflect evidence-based standard care, in a telerehabilitation format.
干预措施: Standard home-based exercise therapy (Other)
结局指标
主要结局
Change in Western Ontario Shoulder Instability Index (WOSI)
时间窗: Measured at baseline, 6 weeks, 12 weeks and 24 weeks, in order to assess the change in WOSI from baseline to 6 weeks, 12 weeks, and 24 weeks
The WOSI is a responsive patient-reported and disease-specific tool, designed to be used as the primary outcome measure in clinical trials that assess treatments for patients with shoulder instability. Range 0 - 2100 points. Higher scores express worse status.
次要结局
- The Tampa Scale for Kinesiophobia (TSK)(Measured at baseline, 6 weeks, 12 weeks and 24 weeks)
- The Patient-Specific Functional Scale (PSFS)(Measured at baseline, 6 weeks, 12 weeks and 24 weeks)
- The Disabilities of the Arm Shoulder and Hand (DASH)(Measured at baseline, 6 weeks, 12 weeks and 24 weeks)
- The Global Rating of Change (GROC)(Measured at baseline, 6 weeks, 12 weeks and 24 weeks)
- Pain pressure thresholds (PPT)(Measured at baseline, 6 weeks, 12 weeks and 24 weeks)