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临床试验/NCT02882061
NCT02882061已完成不适用

Examination of Cervical Thoracic Differentiation Testing in Individuals With Neck Pain

University of New England0 个研究点目标入组 48 人开始时间: 2016年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
主要终点
Pain measured on Visual Analog Pain Scale (VAS) in the provocative position

研究概览

简要总结

Neck pain is a very common diagnosis and physical therapy, specifically thoracic manipulation, has been shown to be an effective treatment. Thoracic manipulation, which involves a quick thrust type push to a segment of the midback region of the spine, has been shown to decrease pain and improve function in individuals with neck pain. However, it is not known if there is a test that will accurately identify individuals with neck pain who would respond more favorably to thoracic techniques. The Cervical-Thoracic Differentiation Test (CTDT) is a test used clinically to differentiate pain originating from either the cervical (neck) or thoracic (midback) regions of the spine in individuals with neck pain. It has also been speculated that specific unloading tests, where a tester selectively unloads a portion of the weight of the cervical or thoracic spine through manual distraction may help determine who will respond more favorably to thoracic treatment. To the best of our knowledge, despite widespread clinical use, these tests have not been tested for validity or reliability at this time. Therefore, the purposes of this research are to assess the reliability and criterion referenced validity of the CTDT and unloading tests, as well as examine the relationship between tests and baseline subject characteristics.

详细描述

The research aims and hypotheses are:

Aim 1: Evaluate the inter-tester reliability of the CTDT and regional (cervical or thoracic) unloading tests Ho1: The CTDT and regional unloading tests will not demonstrate reliability greater than κ=.75 Ha1: The CTDT and regional unloading tests will demonstrate reliability greater than κ=.75

Aim 2: Determine if there are differences in pain response following thoracic manipulation between subjects with positive and negative CTDT results.

Ho2: There will be no difference in response (change in pain, VAS) following thoracic manipulation between participants with positive CTDT and negative CTDT results Ha2: There will be statistically significant differences in response (change in pain, VAS) between individuals with positive CTDT results compared to those with negative CTDT results

Aim 3: Determine if a relationship exists between CTDT results and the results of cervical and thoracic unloading tests.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria requires subjects to be between the ages of 18 and 60 years and to have a primary complaint of neck pain, 30mm or greater on a 100mm Visual Analog Scale while performing cervical movements. They need to be able to understand and read English.

排除标准

  • Via questionnaire:
  • Symptoms of radiculopathy (pain below elbow, altered sensation), a history of a whiplash injury within 6 weeks of the examination, pregnancy or potential pregnancy, active cancer, fracture, spinal infections, rheumatoid arthritis, severe osteoporosis, history of oral corticosteroid use, previous spine surgery, workman's compensation claims or pending legal action for the individuals neck pain
  • Via physical exam:
  • Identification of any medical signs suggestive of a non-musculoskeletal etiology of symptoms such as inability to change pain with motion, evidence of central nervous system involvement, signs consistent with nerve root compression (at least 2 of the following had to be diminished for nerve root involvement to be considered: myotomal strength, dermatomal sensation, or reflexes).
  • Any volunteers receiving current Workman's Compensation or with active/pending litigation for their shoulders will be excluded

研究组 & 干预措施

CTDT positive

Experimental

All subjects with a positive cervicothoracic differentiation test will be assigned to this arm. All subjects will then receive thoracic spinal manipulation to a level between T1 and T4.

干预措施: Thoracic spinal manipulation (Procedure)

CTDT negative

Active Comparator

All subjects with a negative cervicothoracic differentiation test will be assigned to this arm. All subjects will then receive thoracic spinal manipulation to a level between T1 and T4.

干预措施: Thoracic spinal manipulation (Procedure)

结局指标

主要结局

Pain measured on Visual Analog Pain Scale (VAS) in the provocative position

时间窗: Immediate pre-post intervention

次要结局

  • Pain at rest on VAS(Immediate pre-post intervention)

研究者

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

Brian T Swanson

Assistant Professor

University of New England

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