CompletedNot Applicable

Central Sensitization and Physical Activity in Adolescents With HSD/hEDS

Sweden100 participantsStarted 2022-11-25

Plain-language summary

Hypermobility Spectrum Disorder and hypermobile Ehlers-Danlos Syndrome (HSD/hEDS) is under-recognized and poorly understood and its management is therefore not clear. The goal of this study is to better understand pain and its impact on function in the daily activities of adolescents with Hypermobility Spectrum Disorder and/or hypermobile Ehlers-Danlos Syndrome. This study will explore the presence of the pain sensitivity status after physical exercise as well as movement behaviour in adolescents with HSD/hEDS compared to a healthy control group.

Who can participate

Age range

13 Years – 17 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 for the HSD/hEDS group: * Able to read and understand Swedish * Diagnosed with HSD or hEDS Exclusion criteria for the HSD/hEDS group: * Pregnancy and one year postpartum. * Other syndromes with hypermobility such as the Marfan syndrome, Osteogenesis Imperfecta or other types of EDS. * Co-morbidity with neurological disorders Inclusion criteria for the control group: * Able to read and understand Swedish * Healthy * Pain free at time of investigation (Numerical Rating Scale score \<3/10). Exclusion criteria for the control group: * Pregnancy and one year postpartum. * Past or present signs of rheumatic, neurologic, musculoskeletal, metabolic diseases. * Chronic pain.

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

Pressure Pain thresholds, primary and secondary hyperalgesia

Timeframe: Baseline, pre-intervention

Change of Pressure Pain thresholds, exercise-induced hyperalgesia

Timeframe: Immediately after the intervention

Trial details

NCT IDNCT05633225

SponsorVastra Gotaland Region

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Joint Hypermobility Syndrome trials