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Completed

NCT Number: NCT04734041

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

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

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Key information

Conditions

Ehlers-Danlos Syndrome Cardiovascular Diseases Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases EDS Ehlers-Danlos syndrome type 3 Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hypermobile EDS (hEDS) Hypermobility Syndrome Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Healthy Living Community, Portland, Oregon, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-inflammatory (Mediterranean-style) diet

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

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 9 weeks

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

  2. Retention rate

    Time frame: 9 weeks

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

Secondary outcomes

  1. Adherence to the dietary recommendations

    Time frame: 5, 9 weeks

    Estimated daily dietary intake recorded in a food tracker app

  2. Adherence to food tracking

    Time frame: 5, 9 weeks

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

Other outcomes

  1. Visual Analog Scale for Pain (VAS)

    Time frame: Baseline, 5 weeks, 9 weeks

    Baseline, 5-week, and 9-week pain scale scores on a 10-point scale. The numeric measurement of pain between 0 "no pain" and 10 representing "worst pain" will be used.

  2. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: Baseline, 5 weeks, 9 weeks

    Baseline, 5-week, and 9-week PROMIS pain intensity on a scale of 0 to 10. Higher scores represent greater intensity of pain.

  3. Patient Assessment of Chronic Illness Care (PACIC+)

    Time frame: Baseline, 5 weeks, 9 weeks

    Baseline, 5-week, and 9-week assessment. The PACIC+ consists of 26 items with Likert scale responses on a 5 point scale from "Almost never" to "Almost always," with higher scores representing greater satisfaction with care. The PACIC provides summary scores for attitudes regarding patient-centered care, living with chronic illness, and chronic illness care. All subscales are averages of selected items that range between 1 (poor quality of care received) and 5 (excellent quality of care received).

Sponsors and collaborators

Lead sponsor

National University of Natural Medicine

Other

Collaborators

  • Healthy Living Community

Registry information

Official study title

Integrative Medicine for Hypermobility Spectrum Disorder (HSD) and Ehlers-Danlos (EDS) Syndromes: A Mixed-methods Feasibility Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 2, 2021
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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