Ehlers-Danlos Syndrome Clinical Trial
Official title:
Integrative Medicine for Hypermobility Spectrum Disorder (HSD) and Ehlers-Danlos (EDS) Syndromes: A Mixed-methods Feasibility Study
NCT number | NCT04734041 |
Other study ID # | DH10320 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 23, 2020 |
Est. completion date | July 2, 2021 |
Verified date | July 2021 |
Source | National University of Natural Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A feasibility study of an integrative medicine program among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS)
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 |
Country | Name | City | State |
---|---|---|---|
United States | Healthy Living Community | Portland | Oregon |
United States | National University of Natural Medicine | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
National University of Natural Medicine | Healthy Living Community |
United States,
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 |
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