跳至主要内容
临床试验/NCT03730896
NCT03730896终止不适用

Effectiveness of Dry Needling of the Sternocleidomastoid in Patients With Cervicogenic Headaches - A Randomized Clinical Trial

Florida Gulf Coast University2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
17
试验地点
2
主要终点
Change in Headache Disability Index (HDI) score

研究概览

简要总结

Evaluating the benefit of dry needling of the sternocleidomastoid muscle in subjects with cervicogenic headaches.

详细描述

The purpose of this study is to determine whether individuals with cervicogenic headache respond favorably to a program of manual therapy in combination with dry needling of the major muscle between chest bone and the head (sternocleidomastoid muscle) compared to manual therapy directed to the upper body quadrant alone.

The researchers will conduct a randomized clinical trial to assess the effectiveness of a manual therapy and dry needling approach (group 1) vs. manual therapy only. (group 2)

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 (Participant)

盲法说明

Random assignment to dry needle group or control group with standard manual therapy interventions

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-65 years old
  • Primary complaint of cervicogenic headache
  • Restricted cervical Range of motion
  • Neck Disability Index > 20 points

排除标准

  • Red flags identified during the patients physical therapy initial evaluation (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, symptoms of vertebrobasilary insufficiency, pregnancy, cervical spinal stenosis, bilateral upper extremity symptoms etc.
  • Use of blood thinners
  • History of whiplash injury within the past six weeks
  • Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
  • Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
  • Muscle weakness involving a major muscle group of the upper extremity
  • Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps)
  • Diminished or absent sensation to pinprick in any upper extremity dermatome
  • Prior surgery to the neck or thoracic spine
  • Chiropractic, Physical Therapy, or Acupuncture treatment for their neck pain in the last 6-months
  • Workers compensation or pending legal action regarding their headaches
  • Insufficient English language skills to complete all questionnaires
  • Inability to comply with treatment and follow-up schedule

结局指标

主要结局

Change in Headache Disability Index (HDI) score

时间窗: At initial evaluation (day 1), week three (day 21) and week 6 (day 42)

Questionnaire for self report, this will be on a 0-100 score

次要结局

  • Change in cervical range of motion using an inclinometer/ change in high cervical range of motion using the Flexion-Rotation Test (FRT)(At initial evaluation (day 1), week three (day 21) and week 6 (day 42))
  • Change in the neck disability Index score(At initial evaluation (day 1), week three (day 21) and week 6 (day 42))
  • Change in visual analogue scale score(At initial evaluation (day 1), week three (day 21) and week 6 (day 42))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验