Clinical Trials Directory

Trials / Completed

CompletedNCT05633225

Central Sensitization and Physical Activity in Adolescents With HSD/hEDS

Measuring Central Sensitization and Physical Activity in Adolescents With Hypermobility Spectrum Disorder or Hypermobile Ehlers-Danlos Syndrome

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Vastra Gotaland Region · Other Government
Sex
All
Age
13 Years – 17 Years
Healthy volunteers
Accepted

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.

Detailed description

All participants will be asked not to undertake physical exercise at least 48 hours before the measurements, and to refrain from consuming caffeine, alcohol or nicotine. For ethical reasons, the patients are allowed to take non-opioid pain medicine as described in the first step of the World Health Organization analgesic ladder (COX-inhibitors and paracetamol), however the patients will be asked to abstain from these medications during the 24 hours period before the measurements.

Conditions

Interventions

TypeNameDescription
OTHERSubmax exercise test on a bicycle ergometerTo achieve exertion and not exhaustion, cycling will be stopped at 75% of the expected maximum heart rate (maximum heart rate of 220 beats per minute minus age) as a target value. If the participant then indicated that they do not feel strained, the cycling will continue until the participant experienced an effort on Borg Rating of Perceived Exertion Scale scale of 15 (hard).

Timeline

Start date
2022-11-25
Primary completion
2023-06-30
Completion
2023-10-31
First posted
2022-12-01
Last updated
2023-11-07

Locations

2 sites across 1 country: Sweden

Source: ClinicalTrials.gov record NCT05633225. Inclusion in this directory is not an endorsement.