Integrative Medicine for Hypermobility Spectrum Disorder and Ehlers-Danlos Syndromes (IMforHSDandEDS)

National University of Natural Medicine20 enrolled

Overview

A feasibility study of an integrative medicine program among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS)

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Ehlers-Danlos Syndrome Hypermobile EDS (hEDS)Hypermobility Syndrome EDS

Interventions

Anti-inflammatory (Mediterranean-style) dietBEHAVIORAL

Prescription of an anti-inflammatory diet, which encourages increasing whole fruits, vegetables, and grains, as well as balancing macronutrients (proteins, carbohydrates, and fat) for every meal.

Behavioral and psychosocial supportBEHAVIORAL

Capture a complete and detailed medical history and background. Discuss familial and social support, provide psychosocial support, assess the patient's current self-management strategies for self-care, and assess the patient's current self-management strategies for mental health. Recommendations will be made in accordance with the needs of the participant.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Locations (2)

National University of Natural Medicine

Portland, Oregon, United States

Healthy Living Community

Portland, Oregon, United States

Outcomes

Primary Outcomes

Recruitment rate

Number of participants enrolled per month, over the 4 month open recruitment

Time frame: 9 weeks

Retention rate

Proportion of participants completing the mid-study or end-of-study visits

Time frame: 9 weeks

Secondary Outcomes

Adherence to the dietary recommendations

Estimated daily dietary intake recorded in a food tracker app

Time frame: 5, 9 weeks

Adherence to food tracking

Reporting per week of dietary intake recorded in a food tracker app

Time frame: 5, 9 weeks

Data from ClinicalTrials.gov

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