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

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

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

Study Overview

• Status: Completed
• Conditions: Ehlers-Danlos Syndrome; Hypermobile EDS (hEDS); Hypermobility Syndrome; EDS
• Intervention / Treatment: Behavioral: Anti-inflammatory (Mediterranean-style) diet; Behavioral: Behavioral and psychosocial support

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97201
      • National University of Natural Medicine
    • Portland, Oregon, United States, 97202
      • Healthy Living Community

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Integrative Medicine; Anti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support.

Behavioral: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the dietary recommendations	Estimated daily dietary intake recorded in a food tracker app	5, 9 weeks
Adherence to food tracking	Reporting per week of dietary intake recorded in a food tracker app	5, 9 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale for Pain (VAS)	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.	Baseline, 5 weeks, 9 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	Baseline, 5-week, and 9-week PROMIS pain intensity on a scale of 0 to 10. Higher scores represent greater intensity of pain.	Baseline, 5 weeks, 9 weeks
Patient Assessment of Chronic Illness Care (PACIC+)	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).	Baseline, 5 weeks, 9 weeks

Collaborators and Investigators

• Sponsor: National University of Natural Medicine
• Collaborators: Healthy Living Community
• Investigators: Study Chair: Rich Barrett, ND, NUNM Institutional Review Board Chair

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2020
• Primary Completion (Actual): July 2, 2021
• Study Completion (Actual): July 2, 2021

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Disease; Congenital Abnormalities; Hematologic Diseases; Hemorrhagic Disorders; Genetic Diseases, Inborn; Connective Tissue Diseases; Hemostatic Disorders; Skin Diseases, Genetic; Skin Abnormalities; Collagen Diseases; Syndrome; Ehlers-Danlos Syndrome; Anti-Inflammatory Agents
• Other Study ID Numbers: DH10320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No