Measuring Central Sensitization and Physical Activity in Adolescents With Hypermobility Spectrum Disorder or Hypermobile Ehlers-Danlos Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Pressure Pain thresholds, primary and secondary hyperalgesia
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pressure Pain thresholds, primary and secondary hyperalgesia
Time Frame: Baseline, pre-intervention
A hand-held pressure algometer (Wagner Instruments, FPX 25) will be used to assess pressure pain thresholds (PPT). The 1 cm2 rubber tip of the algometer will be positioned at an angle of 90 degrees in relation to the body part evaluated and pressure will be applied at a rate of 1 kg/s. PPT measurements will be carried out on the lower back in the supine position, on the tibialis anterior in the prone position, on the trapezius and deltoid while sitting. The participants will be instructed to say "stop" as soon as the sensation of a pressure changes to an uncomfortable feeling. The pressure algometer will be removed immediately and the recorded value will be noted. This procedure will be repeated time three times at each test location (30 seconds between each measurement). Average value of the last two measurements is used as the baseline. The order of the PPT measurement points will be randomized for each group.
Change of Pressure Pain thresholds, exercise-induced hyperalgesia
Time Frame: Immediately after the intervention
Exercise-induced hyperalgesia will be measured by repeating the pressure pain thresholds (PPT) measures at the trapezius muscle and the tibialis anterior muscle (as described above) immediately after the performance of an submax exercise test on a bicycle ergometer The order of the PPT measurement points in the exercise-induced hyperalgesia measurements will be randomized for each group.
Secondary Outcomes
- Numerical rating scale(Baseline, pre-intervention and immediately after the intervention)
- Heart rate(Immediately after the intervention)
- Hospital anxiety and depression scale(Immediately after the intervention)
- Physical activity(Continuous measurement over seven days, immediately after the intervention)
- Borg Rating of Perceived Exertion Scale(Immediately after the intervention)
- Medical examination(Baseline, pre-intervention)
- Beighton scale(Baseline, pre-intervention)
- Demographics child(Baseline, pre-intervention)
- Demographics caregiver(Baseline, pre-intervention)
- Functional Disability Inventory(Immediately after the intervention)
- Frequency of Participation Questionnaire(Immediately after the intervention)
- Multidimensional Fatigue Scale(Immediately after the intervention)
- Pain Catastrophizing scale(Immediately after the intervention)
- Diary(Continuous measurement over seven days, immediately after the intervention)
Investigators
Elke Schubert Hjalmarsson
RPT, Head of the occupational therapy and physiotherapy unit for children
Vastra Gotaland Region