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

NCT04734041 | Completed

• 1 other identifier: DH10320
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Recruitment rate

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

  9 weeks

• Retention rate

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

  9 weeks

Secondary Outcomes (2)

• Adherence to the dietary recommendations

  5, 9 weeks

• Adherence to food tracking

  5, 9 weeks

Other Outcomes (3)

• Visual Analog Scale for Pain (VAS)

  Baseline, 5 weeks, 9 weeks

• Patient-Reported Outcomes Measurement Information System (PROMIS-29)

  Baseline, 5 weeks, 9 weeks

• Patient Assessment of Chronic Illness Care (PACIC+)

  Baseline, 5 weeks, 9 weeks

Study Arms (1)

Integrative Medicine

OTHER

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

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

Interventions

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.

Integrative Medicine

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.

Integrative Medicine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Natural Medicine: lead
• Healthy Living Community: collaborator

Study Sites (2)

National University of Natural Medicine

Portland, Oregon, 97201, United States

Location

Healthy Living Community

Portland, Oregon, 97202, United States

Location

Related Publications (1)

• Guedry SE, Langley BO, Schaefer K, Hanes DA. Integrative medicine for hypermobility spectrum disorders (HSD) and Ehlers-Danlos syndromes (EDS): a feasibility study. Disabil Rehabil. 2024 Dec;46(24):5854-5867. doi: 10.1080/09638288.2024.2314713. Epub 2024 Feb 14.

  PMID: 38353245 DERIVED

MeSH Terms

Conditions

Ehlers-Danlos Syndrome; Ehlers-Danlos syndrome type 3

Interventions

Anti-Inflammatory Agents; Diet; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rich Barrett, ND

  NUNM Institutional Review Board Chair

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Investigator

Model Details: Feasibility study

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 2, 2021
• Study Start: December 23, 2020
• Primary Completion: July 2, 2021
• Study Completion: July 2, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)