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临床试验/NCT05444296
NCT05444296Unknown不适用

Superficial Dry Needling of the Trigeminal Nerve Innervation Sensory Field for Cervicogenic Headache: a Randomized Clinical Trial

Youngstown State University2 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2022年7月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
133
试验地点
2
主要终点
Headache or neck pain intensity on a Numeric pain rating scale (0-10)

研究概览

简要总结

It is unknown if applying superficial dry needling to the trigeminal innervation field improves pain and disability for patients with cervicogenic headaches. The aim of this study is to determine if superficial dry needling of the trigeminal innervation field improves pain, neck mobility, and disability in patients with cervicogenic headaches. It will also be examined if psychosocial factors such as stress, anxiety, depression and self efficacy influence improvements in pain, range of motion and neck disability.

详细描述

Cervicogenic headache (CGH), is defined by the International Classification of Headache Disorders (ICHD) as a "headache caused by a disorder of the cervical spine and its component bony, disc, and/or soft tissue elements, usually but not invariably accompanied by neck pain. Prevalence of CGH in the general population is between .4-20%. Although the primary source of pain is generated from the upper cervical spinal levels, there is also neuro-anatomical basis of CGH involving the trigeminal nerve.

Dry needling (DN) is a widely used intervention performed by physical therapists for a wide range of musculoskeletal and neurological conditions. Dry needling has been shown to be beneficial for CGH but DN has only been investigated using trigger point DN to cervical musculature. Superficial DN also reduces pain associated to orthopedic spinal conditions and may be associated with a lower risk of post-treatment soreness.

Non-thrust mobilizations of the cervical spine are an accepted treatment known to reduce pain and disability associated with CGH. Their use has also been recommended in clinical practice guidelines.

This study aims to look investigate whether superficial dry needling targeting the trigeminal innervation sensory field will reduce pain and impairments known to exist in patients with CGH compared to mobilizations of the cervical spine. Mobilizations of the cervical spine are another common treatment that physical therapists employ to treat cervicogenic headaches.

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
Single (Outcomes Assessor)

盲法说明

Outcome assessor will be blind to the type of intervention the participant receives.

入排标准

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

入选标准

  • Aged 18 or older
  • Symptoms: (1)Unilateral pain starting in the neck and radiating to the frontotemporal region or posterior fossa, (2) pain aggravated by neck movement, (3) restricted cervical range of motion, (4) non-throbbing and non-lancinatingnpain, 5) dysfunction/headache pain in at least one of the joints of the upper cervical spine(C0-C4), and (6) headache frequency of at least 1 per week over a period greater than 3 months.

排除标准

  • Headache or neck pain <2/10
  • Contraindications to the interventions
  • Whiplash associated disorder within 6 weeks
  • Pending litigation for neck pain and/or headache.
  • Unwilling to cease other care through duration of study

结局指标

主要结局

Headache or neck pain intensity on a Numeric pain rating scale (0-10)

时间窗: <1 hour

0-10 scale pain intensity, 0 is no pain, 10 is severe pain, the lower the score the better

次要结局

  • Flexion Rotation Test in degrees of measurement(<1 hour)
  • Short Form 36 (SF-36)(<1 hour)
  • Severity Measure for Specific Phobia-Adult (SMSP-A)(<1 hour)
  • Active Range of Motion of the Cervical Spine in degrees of measurement(<1 hour)
  • Neck Disability Index (NDI)(<1 hour)
  • Generalized Anxiety Disorder 7 (GAD-7)(<1 hour)
  • Patient Health Questionnaire - 9 (PHQ-9)(<1 hour)
  • Headache Self Efficacy Scale (HSES)(<1 hour)
  • Injection Phobia Scale (IPS)(<1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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