Central Sensitization and Physical Activity in Adolescents With HSD/hEDS

NCT ID: NCT05633225

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-25

Study Completion Date

2023-10-31

Brief Summary

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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

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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

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Joint Hypermobility Syndrome Hypermobile Ehlers-Danlos Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patient-group

Ninety adolescents, 13-17 years of age Diagnosed with Hypermobility Spectrum Disorder or hypermobile Ehlers Danlos Syndrome.

Submax exercise test on a bicycle ergometer

Intervention Type OTHER

To 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).

Control-group

Ninety adolescents, 13-17 years of age. Participants have to be pain free at time of investigation (NRS score \<3/10)

Submax exercise test on a bicycle ergometer

Intervention Type OTHER

To 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).

Interventions

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Submax exercise test on a bicycle ergometer

To 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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Able to read and understand Swedish
* Diagnosed with HSD or hEDS


* Able to read and understand Swedish
* Healthy
* Pain free at time of investigation (Numerical Rating Scale score \<3/10).

Exclusion Criteria

* 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


* Pregnancy and one year postpartum.
* Past or present signs of rheumatic, neurologic, musculoskeletal, metabolic diseases.
* Chronic pain.
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Göteborg University

OTHER

Sponsor Role collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Elke Schubert Hjalmarsson

RPT, Head of the occupational therapy and physiotherapy unit for children

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mari Lundberg, Professor

Role: STUDY_DIRECTOR

University of Gothenborg

Locations

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Sahlgrenska University Hospital

Gothenburg, Region Västra Götaland, Sweden

Site Status

Skaraborgs Hospital Skövde

Skövde, Region Västra Götaland, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 28145606 (View on PubMed)

Schubert-Hjalmarsson E, Fridolfsson J, Arvidsson D, Borjesson M, Lundberg M. Exploring physical activity patterns in adolescents with hypermobility spectrum disorder or hypermobile Ehlers-Danlos Syndrome. Pediatr Rheumatol Online J. 2025 Jul 8;23(1):69. doi: 10.1186/s12969-025-01124-0.

Reference Type DERIVED
PMID: 40629345 (View on PubMed)

Related Links

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Other Identifiers

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CSaPhA-HSD/hEDS

Identifier Type: -

Identifier Source: org_study_id

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