Measuring Central Sensitization and Physical Activity in Adolescents With Hypermobility Spectrum Disorder or Hypermobile Ehlers-Danlos Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pressure Pain thresholds, primary and secondary hyperalgesia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pressure Pain thresholds, primary and secondary hyperalgesia
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Elke Schubert Hjalmarsson
RPT, Head of the occupational therapy and physiotherapy unit for children
Vastra Gotaland Region