Clinical trial NCT05633225: Central Sensitization and Physical Activity in Adolescents With HSD/hEDS
Official title: Measuring Central Sensitization and Physical Activity in Adolescents With Hypermobility Spectrum Disorder or Hypermobile Ehlers-Danlos Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Joint Hypermobility Syndrome
Hypermobile Ehlers-Danlos Syndrome
Keywords: Pain
Hypermobility
Physical activity
Central sensitization
Fatigue
Ehlers Danlos Syndrome
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
First posted: 2022-12-01
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolecents diagnosed with HSD/hEDS, at Children's Primary Health Care Clinics in Gothenburg and Southern Bohuslän, and at Queen Silvia Children's Hospital and Skaraborgs hospital Skövde will be asked to participate. In addition, a control group of healthy pain free adolecents, matched for sex, age will be recruited from different schools in the region, throw hospital stuff and social media.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pressure Pain thresholds, primary and secondary hyperalgesia
timeFrame: Baseline, pre-intervention
measure: Change of Pressure Pain thresholds, exercise-induced hyperalgesia
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Numerical rating scale
timeFrame: Baseline, pre-intervention and immediately after the intervention
measure: Heart rate
timeFrame: Immediately after the intervention
measure: Borg Rating of Perceived Exertion Scale
timeFrame: Immediately after the intervention
measure: Medical examination
timeFrame: Baseline, pre-intervention
measure: Beighton scale
timeFrame: Baseline, pre-intervention
measure: Demographics child
timeFrame: Baseline, pre-intervention
measure: Demographics caregiver
timeFrame: Baseline, pre-intervention
measure: Functional Disability Inventory
timeFrame: Immediately after the intervention
measure: Frequency of Participation Questionnaire
timeFrame: Immediately after the intervention
measure: Multidimensional Fatigue Scale
timeFrame: Immediately after the intervention
measure: Pain Catastrophizing scale
timeFrame: Immediately after the intervention
measure: Hospital anxiety and depression scale
timeFrame: Immediately after the intervention
measure: Physical activity
timeFrame: Continuous measurement over seven days, immediately after the intervention
measure: Diary
timeFrame: Continuous measurement over seven days, immediately after the intervention
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Region Västra Götaland
city: Skövde
country: Sweden
facility: Skaraborgs Hospital Skövde
state: Region Västra Götaland
Study officials:
affiliation: University of Gothenborg
name: Mari Lundberg, Professor
role: STUDY_DIRECTOR
References:
citation: Castori M, Tinkle B, Levy H, Grahame R, Malfait F, Hakim A. A framework for the classification of joint hypermobility and related conditions. Am J Med Genet C Semin Med Genet. 2017 Mar;175(1):148-157. doi: 10.1002/ajmg.c.31539. Epub 2017 Feb 1.