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

Ehlers-Danlos Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04734041
• Other study ID #: DH10320
• Status: Completed
• Phase: N/A
• Start date: December 23, 2020
• Est. completion date: July 2, 2021

Study information

• Verified date: July 2021
• Source: National University of Natural Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2, 2021
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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 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.

Locations

Country	Name	City	State
United States	Healthy Living Community	Portland	Oregon
United States	National University of Natural Medicine	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
National University of Natural Medicine	Healthy Living Community

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	Recruitment rate	Number of participants enrolled per month, over the 4 month open recruitment	9 weeks
Primary	Retention rate	Proportion of participants completing the mid-study or end-of-study visits	9 weeks
Secondary	Adherence to the dietary recommendations	Estimated daily dietary intake recorded in a food tracker app	5, 9 weeks
Secondary	Adherence to food tracking	Reporting per week of dietary intake recorded in a food tracker app	5, 9 weeks