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Central Sensitization and Physical Activity in Adolescents With HSD/hEDS

V

Vastra Gotaland Region

Status

Completed

Conditions

Joint Hypermobility Syndrome
Hypermobile Ehlers-Danlos Syndrome

Treatments

Other: Submax exercise test on a bicycle ergometer

Study type

Observational

Funder types

Other

Identifiers

NCT05633225
CSaPhA-HSD/hEDS

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

13 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

100 participants in 2 patient groups

Patient-group
Description:
Ninety adolescents, 13-17 years of age Diagnosed with Hypermobility Spectrum Disorder or hypermobile Ehlers Danlos Syndrome.
Treatment:
Other: Submax exercise test on a bicycle ergometer
Control-group
Description:
Ninety adolescents, 13-17 years of age. Participants have to be pain free at time of investigation (NRS score \<3/10)
Treatment:
Other: Submax exercise test on a bicycle ergometer

Trial contacts and locations

2

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Central trial contact

Elke S Hjalmarsson, PhD-student; Mari Lundberg, Professor

Data sourced from clinicaltrials.gov

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