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临床试验/NCT04125901
NCT04125901已完成不适用

Chronic Idiopathic Neck Pain in High School Students: Effectiveness of an Intervention Based on Exercise and Pain Neuroscience Education

Aveiro University3 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
127
试验地点
3
主要终点
Intensity of pain

研究概览

简要总结

Musculoskeletal pain can affect up to 40% of children and adolescents. Neck pain (NP) is one of the most prevalent painful conditions and evidence suggests that its prevalence has increased in recent decades in adolescents aged 16 to 18 years, from 22.9% in 1991 to 29.5% in 2011. Interventions based on pain neuroscience education have emerged as promising strategies in chronic pain conditions.In adults this intervention has been explored in many pain conditions, including musculoskeletal pain, but there is only one pilot study in adolescents with chronic NP and one case study in adolescents with fibromyalgia.

Thus, the main objective of the present study is:

(i) To compare the effectiveness of an education program based on pain neuroscience education and exercise versus exercise alone, in decreasing pain intensity in secondary school students with chronic and idiopathic NP immediately after the intervention and at 6 months.

The secondary objectives are to:

i) Compare the effectiveness of these programs immediately after the intervention and at 6 months in i) disability, ii) sleep, iii) pain catastrophizing, iv) fear of movement, v) self-efficacy, vi) central sensitization vii) the strength of the deep neck flexors and extensors muscles and stabilizers of the scapula; and viii) the pressure pain threshold between the two intervention groups;

ii) Explore possible predictors of response to treatment.

详细描述

It is anticipated that the sample will consist of 127 participants from four secondary schools that will be divided into two groups. Both groups will receive the same exercise-based intervention. The experimental group will receive, in addition to exercise, an intervention based on pain neuroscience education. The intervention will consist of 1 session per week during 8 weeks and will be applied in small groups.

The intervention will be performed in a blended-learning format. Five sessions will be face-to-face with up to 45 minutes duration, performed at school and incorporated into physical education classes and 3 will be performed at home, supported by vídeos sent by WhatsApp. The first two sessions will always be face-to-face. Face-to-face sessions will be interspersed with WhatsApp sessions.

Participants will be assessed, by online questionnaires, for sociodemographic aspects, pain characterization and physical activity level, disability, sleep, catastrophizing, fear of movement, self-efficacy, central sensitization and knowledge on pain neurophysiology. In addition, 3 muscle tests will be performed for the deep neck flexor and extensor muscles and scapular stabilizers, and the pressure pain thresholds in the neck and at distance will be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Students with chronic and idiopathic NP for at least 3 months
  • Have a pain intensity of NPS greater than or equal to 2
  • Not receiving any treatment for NP (except analgesic)

排除标准

  • All students with nervous or rheumatic system pathology
  • Students attending special education (because they may need more accompaniment which, in this group intervention, will not be possible)

结局指标

主要结局

Intensity of pain

时间窗: 6 months

Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)

次要结局

  • Self-efficacy(6 months)
  • Pain location(6 months)
  • Pain frequency(6 months)
  • Sleep(6 months)
  • Muscular resistance of the deep flexor muscles of the cervical(6 months)
  • Disability(6 months)
  • Fear of movement(6 months)
  • Pressure Pain Threshold(6 months)
  • Physical activity(6 months)
  • Pain catastrophizing(6 months)
  • Central Sensitization(6 months)
  • Knowledge of pain neuroscience(6 months)
  • Muscular endurance of the deep cervical extensor muscles(6 months)
  • Muscular resistance of the stabilizing muscles of the scapular girdle(6 months)

研究者

发起方
Aveiro University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosa Andias

Physiotherapist (Master)

Aveiro University

研究点 (3)

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