Clinical trial NCT04734041: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ehlers-Danlos Syndrome
Hypermobile EDS (hEDS)
Hypermobility Syndrome
EDS
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
Collaborators: name: Healthy Living Community
First posted: 2021-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Recruitment rate
timeFrame: 9 weeks
measure: Retention rate
timeFrame: 9 weeks
Secondary outcomes:
measure: Adherence to the dietary recommendations
timeFrame: 5, 9 weeks
measure: Adherence to food tracking
timeFrame: 5, 9 weeks
Other outcomes:
measure: Visual Analog Scale for Pain (VAS)
timeFrame: Baseline, 5 weeks, 9 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: Baseline, 5 weeks, 9 weeks
measure: Patient Assessment of Chronic Illness Care (PACIC+)
timeFrame: Baseline, 5 weeks, 9 weeks
Locations:
city: Portland
country: United States
facility: National University of Natural Medicine
state: Oregon
city: Portland
country: United States
facility: Healthy Living Community
state: Oregon
Study officials:
affiliation: NUNM Institutional Review Board Chair
name: Rich Barrett, ND
role: STUDY_CHAIR
References: