Integrative Medicine for Hypermobility Spectrum Disorder (HSD) and Ehlers-Danlos (EDS) Syndromes: A Mixed-methods Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Recruitment rate
研究概览
简要总结
A feasibility study of an integrative medicine program among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS)
详细描述
The overall purpose of this study is to assess the feasibility of conducting a 9-week integrative medicine program that is comprised of a prescribed anti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS), in order to determine the recruitment potential in this population and to measure the ability of individuals to complete the program. Participants will be prescribed a food plan, and adherence to and feasibility of the food plan will be measured through participant food tracking and a subjective assessment of the food plan in a brief satisfaction survey.
This study aims to recruit 20 patients with HSD or EDS and make preliminary observations regarding the effects of integrative medical care on pain reduction and improved quality of life.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65
- •Beighton score of 4 or more to confirm joint hypermobility diagnosis
- •Baseline VAS Score of 1 or more
- •Not currently, or already a patient of Dr. Schaefer and Healthy Living Community
- •Ability to provide written informed consent
- •Willingness to participate in 9-week integrative medicine intervention (and make dietary and lifestyle changes)
- •Willingness to attend 1 in-person screening visit and 2 virtual office visits (or 3 virtual visits, if medical documentation of Beighton score can be provided in advance of enrollment, and all other criteria are met)
- •Access to an electronic device for MyFitnessPal food-tracker use (i.e mobile device, tablet, laptop)
排除标准
- •Pregnant and lactating women, or planned pregnancy over the next 3 months
- •Consumption of more than 14 (men) or 7 (women) alcoholic drinks per week
- •History of disordered eating or eating disorder
- •Body mass index (BMI) considered underweight (<18.5)
- •Weight loss from metastatic cancer
- •Unable to make dietary changes or participate in a 9-integrative medicine nutritional intervention
- •Those with significant dietary changes, new medications, or new exercise routines within the past 90 days
- •Currently, or already, a patient of Dr. Schaefer and Healthy Living Community
结局指标
主要结局
Recruitment rate
时间窗: 9 weeks
Number of participants enrolled per month, over the 4 month open recruitment
Retention rate
时间窗: 9 weeks
Proportion of participants completing the mid-study or end-of-study visits
次要结局
- Adherence to food tracking(5, 9 weeks)
- Adherence to the dietary recommendations(5, 9 weeks)
研究者
Douglas Hanes
Associate Investigator
National University of Natural Medicine