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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anti-inflammatory (Mediterranean-style) diet
Behavioral and psychosocial support
Sponsored by
National University of Natural Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ehlers-Danlos Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • National University of Natural Medicine
  • Healthy Living Community

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Integrative Medicine

Arm Description

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

Outcomes

Primary Outcome Measures

Recruitment rate
Number of participants enrolled per month, over the 4 month open recruitment
Retention rate
Proportion of participants completing the mid-study or end-of-study visits

Secondary Outcome Measures

Adherence to the dietary recommendations
Estimated daily dietary intake recorded in a food tracker app
Adherence to food tracking
Reporting per week of dietary intake recorded in a food tracker app

Full Information

First Posted
January 22, 2021
Last Updated
July 14, 2021
Sponsor
National University of Natural Medicine
Collaborators
Healthy Living Community
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1. Study Identification

Unique Protocol Identification Number
NCT04734041
Brief Title
Integrative Medicine for Hypermobility Spectrum Disorder and Ehlers-Danlos Syndromes (IMforHSDandEDS)
Official Title
Integrative Medicine for Hypermobility Spectrum Disorder (HSD) and Ehlers-Danlos (EDS) Syndromes: A Mixed-methods Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 23, 2020 (Actual)
Primary Completion Date
July 2, 2021 (Actual)
Study Completion Date
July 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Natural Medicine
Collaborators
Healthy Living Community

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ehlers-Danlos Syndrome, Hypermobile EDS (hEDS), Hypermobility Syndrome, EDS

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrative Medicine
Arm Type
Other
Arm Description
Anti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support.
Intervention Type
Behavioral
Intervention Name(s)
Anti-inflammatory (Mediterranean-style) diet
Intervention Description
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
Intervention Name(s)
Behavioral and psychosocial support
Intervention Description
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 Outcome Measure Information:
Title
Recruitment rate
Description
Number of participants enrolled per month, over the 4 month open recruitment
Time Frame
9 weeks
Title
Retention rate
Description
Proportion of participants completing the mid-study or end-of-study visits
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Adherence to the dietary recommendations
Description
Estimated daily dietary intake recorded in a food tracker app
Time Frame
5, 9 weeks
Title
Adherence to food tracking
Description
Reporting per week of dietary intake recorded in a food tracker app
Time Frame
5, 9 weeks
Other Pre-specified Outcome Measures:
Title
Visual Analog Scale for Pain (VAS)
Description
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.
Time Frame
Baseline, 5 weeks, 9 weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Description
Baseline, 5-week, and 9-week PROMIS pain intensity on a scale of 0 to 10. Higher scores represent greater intensity of pain.
Time Frame
Baseline, 5 weeks, 9 weeks
Title
Patient Assessment of Chronic Illness Care (PACIC+)
Description
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).
Time Frame
Baseline, 5 weeks, 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rich Barrett, ND
Organizational Affiliation
NUNM Institutional Review Board Chair
Official's Role
Study Chair
Facility Information:
Facility Name
National University of Natural Medicine
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Healthy Living Community
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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