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临床试验/NCT02816060
NCT02816060已完成不适用

Effectiveness of Neural Tensioner Exercise on Conditioned Pain Modulation, Disability and Range of Motion in Patients With Chronic Neck Pain: A Randomized Clinical Trial

Universidad Rey Juan Carlos2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Physiological parameter

研究概览

简要总结

Background: There is evidence linking conditioned pain modulation (CPM) deficiency with musculoskeletal pain syndromes such as fibromyalgia, migraine, tension-type headaches and irritable bowel syndrome, as well as with temporomandibular disorders, idiopathic facial pain and chronic fatigue syndrome. Evidence shows that in pre-surgical situations of chronic pain there is no activation of CPM.

Objectives: The purpose of this study is to measure the CPM response and determine whether neural tensioner exercise in patients with chronic neck pain is effective in the improvement of neck pain intensity, neck disability and cervical range of motion.

Design: Double-blind, randomized placebo clinical trial. Methods: Patients with neck pain will be randomly allocated into two groups: the neural tensionner exercise group (NTE) or the sham technique (ST) group.

Individuals will be included in the study if they meet the following inclusion criteria: aged 18-65 years, neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head. Neck pain intensity with a visual analogue scale (VAS), neck disability index (NDI), CPM, and cervical rang of motion will be measured pre and port intervention.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • aged 18-65 years.
  • neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head, trunk, and/or the upper limbs.
  • the ability to understand, write, and speak Spanish fluently

排除标准

  • development of systemic or degenerative diseases;
  • symptoms of depression according to Beck's questionnaire.
  • pain in any area between the lower back and the head in the last 9 months.
  • neck pain associated with whiplash injuries.
  • medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis). - neck pain with cervical radiculopathy.
  • neck pain associated with externalized cervical disc herniation.
  • fibromyalgia syndrome.
  • previous neck surgery.
  • neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches due to a traumatic event in the past 12 months.
  • and history of neck or face pain in the last 6 months.

结局指标

主要结局

Physiological parameter

时间窗: 5 minutes

Conditioned pain modulation: Diffusse noxious inhibitory control sistem will be measure with torniquete test

次要结局

  • physiological movement(5 minutes)
  • Visual analogue scale(5 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Josue Fernandez Carnero

PT, PhD

Universidad Rey Juan Carlos

研究点 (2)

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