CompletedNot Applicable

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

United States20 participantsStarted 2020-12-23

Plain-language summary

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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment rate

Timeframe: 9 weeks

Retention rate

Timeframe: 9 weeks

Trial details

NCT IDNCT04734041

SponsorNational University of Natural Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-02

View on ClinicalTrials.gov More Ehlers-Danlos Syndrome trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.