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临床试验/NCT02081456
NCT02081456已完成不适用

The Effects of Soft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain With Evidence of Neural Mechanical Sensitivity: A Randomized Clinical Trial

Emilio J Puentedura, PT, DPT, PhD0 个研究点目标入组 23 人开始时间: 2009年11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
发起方
入组人数
23
主要终点
Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion

研究概览

简要总结

The purpose of this study is to investigate effects of soft tissue mobilization versus therapeutic ultrasound in subjects with neck and arm pain who demonstrate neural mechanical sensitivity.

详细描述

To investigate the immediate effects of soft tissue mobilization (STM) versus therapeutic ultrasound (US) in patients with neck and arm pain who demonstrate neural mechanical sensitivity. Twenty-three patients with neck and arm pain and a positive upper limb neurodynamic test (ULNT) were randomly assigned to receive STM or therapeutic US during a single session. Outcome measures were collected immediately before and after treatment, and at 2-4 day follow-up. Primary outcomes were the Global Rating of Change (GROC), range of motion (ROM) during the ULNT, and pain rating during the ULNT. Secondary measures included the Neck Disability Index (NDI), Patient-Specific Functional Scale (PSFS), Numeric Pain Rating Scale (NPRS), and active range of shoulder abduction motion combined with the wrist neutral or wrist extension.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Active movement dysfunction that could be related to mechanical sensitivity of the neural structures of the upper limb. (i.e. painful shoulder abduction with elbow extension that is limited more when the wrist is extended than when the wrist is in neutral.)
  • Positive response to upper limb neural provocation testing (ULNT 1) (see description below for details)
  • Tenderness to palpation over the cervical nerve trunks, brachial plexus, or along the median nerve.
  • Tender points or taut bands in the muscles of the upper quadrant including the scalenes, cervical paraspinals, trapezius, deltoid, pectoralis major or minor, rotator cuff, biceps, triceps, coracobrachialis, brachialis, radiobrachialis, pronator teres, supinator, forearm extensor, forearm flexor, pronator quadratus, and hand intrinsic muscles.

排除标准

  • Red flags noted in the medical screening questionnaire such as tumor, fracture, history of metabolic disease, prolonged history of corticosteroid use.
  • Signs of central nervous system involvement such as hyper-reflexia (exaggerated response to deep tendon reflex testing), unsteadiness during gait, ataxia, disturbed vision, nystagmus, altered taste, positive Babinski's or Hoffman's reflexes.
  • Cervical spine surgery within the last 3 months.
  • Litigation associated with their neck and/or upper limb pain.
  • Insufficient English language skills to complete the questionnaires and follow-up instructions.
  • Inability to complete the treatment and follow-up schedule.
  • Current pregnancy.

研究组 & 干预措施

Therapeutic Ultrasound

Active Comparator

Therapeutic ultrasound applied for a period of 5 minutes to the most painful region of the neck, then a second 5 minute dose at the most painful region of the upper extremity

干预措施: Therapeutic Ultrasound (Device)

Soft Tissue Mobilization

Experimental

Passive soft tissue mobilization to the neck and upper extremity

干预措施: Soft Tissue Mobilization (Other)

结局指标

主要结局

Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion

时间窗: up to 2-4 day follow up

Numeric Pain Rating Scale

时间窗: up to 2-4 day follow up

Measures perceived level of pain on a scale from 0 to 10, where 0 indicates 'no pain' and 10 indicates 'worst imaginable pain'. Therefore, lower scores are better. Outcome results are given and mean changes from pre to post interventions, therefore, a negative value indicates improvement.

次要结局

  • Neck Disability Index(2-4 day follow up)
  • Patient Specific Functional Scale(at 2-4 day follow up)

研究者

发起方
Emilio J Puentedura, PT, DPT, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emilio J Puentedura, PT, DPT, PhD

Co-Principal Investigator

University of Nevada, Las Vegas

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