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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-23

Study Completion Date

2021-07-02

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Feasibility study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Integrative Medicine

Anti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support.

Group Type OTHER

Anti-inflammatory (Mediterranean-style) diet

Intervention Type BEHAVIORAL

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 support

Intervention Type BEHAVIORAL

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.

Interventions

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Anti-inflammatory (Mediterranean-style) diet

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.

Intervention Type BEHAVIORAL

Behavioral and psychosocial support

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes