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

National University of Natural Medicine (NUNM) logo

National University of Natural Medicine (NUNM)

Status

Completed

Conditions

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

Treatments

Behavioral: Anti-inflammatory (Mediterranean-style) diet
Behavioral: Behavioral and psychosocial support

Study type

Interventional

Funder types

Other

Identifiers

NCT04734041
DH10320

Details and patient eligibility

About

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

Full description

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.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Integrative Medicine
Other group
Description:
Anti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support.
Treatment:
Behavioral: Anti-inflammatory (Mediterranean-style) diet
Behavioral: Behavioral and psychosocial support

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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