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临床试验/NCT02415660
NCT02415660已完成不适用

Short-Term Response of Thoracic Spine Manipulation With or Without Trigger Point Dry Needling for Mechanical Neck Pain: A Randomized Clinical Trial

Brooke Army Medical Center2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Change in Neck Disability Index (NDI)

研究概览

简要总结

This study will assess the short term response of thoracic spinal manipulation with or without trigger point dry needling in 58 subjects with a primary complaint of mechanical neck pain.

详细描述

Neck pain is common, and return to duty rates after medical evacuation from theater for spinal pain is low. Muscles comprise the majority of the stability for the cervical spine, yet neck muscle function can be altered in the presence of pain. Research has consistently shown the benefit of including thoracic spine manipulation (SMT) in the treatment of patients with mechanical neck pain. Emerging evidence is now also showing promising benefit of including trigger point dry needling (TDN) for the treatment of mechanical neck pain. Treatment regimens commonly address anterior cervical stabilizing musculature, but little is known regarding the response to treatment of the deep posterior stabilizing musculature.

This study will assess the short term response of thoracic SMT with or without TDN in 58 subjects with a primary complaint of mechanical neck pain. Subjects will be randomized to receive 2 treatment visits approximately 2-3 days apart of either SMT+sham TDN or SMT+TDN. TDN will be directed to the upper trapezius and deep cervical extensor muscles of the neck. Outcomes of interest will be changes in function and pain. Assessments will be made at baseline, immediately after the first treatment, at the 2nd treatment, and approximately 5-7 days after the 2nd treatment visit. A subgroup of 20 subjects (10 per group) will also have the upper trapezius and deep cervical extensor muscle activation assessed via shear wave elastography, and deep cervical flexor activation assessed via the craniocervical flexion test.

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, Investigator)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-64 years and eligible for military health care
  • Primary complaint of mechanical neck pain provoked by posture, movement or palpation of neck musculature, with or without unilateral upper extremity symptoms.
  • Presence of active trigger points in either the upper trapezius or deep cervical extensor muscles.
  • Able to make one initial appointment at the Army Medical Department Center and School at Fort Sam Houston, one treatment visit approximately 2-3 days after the initial visit, and then a final outcome visit approximately 5-7 days after 2nd visit.
  • No less than 10 points (0-50 range) on the Neck Disability Index.

排除标准

  • Prior history of whiplash injury resulting in neck pain which required medical treatment.
  • Any prior physical therapy, chiropractic, acupuncture treatment or injections for neck pain within the past 3 months.
  • History of cervical spine surgery.
  • History of any systemic disorder in which thoracic spine manipulation and TDN would be contraindicated (i.e. osteoporosis, bleeding disorders or anticoagulant medication use)
  • Signs and symptoms consistent with nerve root compression (i.e. diminished upper extremity strength, sensation or reflexes), cervical artery insufficiency (i.e. nystagmus, gait disturbances, Horner Syndrome) or upper cervical ligament instability (i.e. Sharp-Purser, alar ligament, transverse ligament tests).
  • Current primary complaint of headaches
  • Pending legal action regarding their neck pain
  • Inability to read and understand English
  • Females known or thought to be pregnant

结局指标

主要结局

Change in Neck Disability Index (NDI)

时间窗: Change in NDI at 7-10 days

The NDI is a revised form of the Oswestry Low Back Pain Index. It is designed to measure the activities of daily living in persons with neck pain.

次要结局

  • Change in Numeric Pain Rating Scale (NPRS)(7-10 days)
  • Change in Deep Neck Flexor (DNF) Activation(7-10 days)
  • Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer.(7-10 days)
  • Global Rate of Change (GRC)(7-10 days)
  • Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE)(7-10 days)

研究者

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

Brian Young

Assistant Professor, Army-Baylor Doctoral Program in PT

Brooke Army Medical Center

研究点 (2)

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