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临床试验/NCT02972710
NCT02972710暂停不适用

A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain: A Randomized Control Trial

Northern Arizona University1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
76
试验地点
1
主要终点
Numerical Pain Rating Scale (NPRS)

研究概览

简要总结

The purpose of this study is to compare the short-term effects of two different thoracic spine thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability in individuals experiencing neck pain.

详细描述

The study will be conducted at the Musculoskeletal clinical facility in the Dept. of Physical Therapy and Athletic Training, Northern Arizona University, Flagstaff AZ. The investigators aim to test a maximum of 76 participants in this study. A phone screening will determine initial eligibility. If the participant meets the inclusion criteria and is not excluded after the phone screen, an appointment will be scheduled. Final eligibility will be determined in the initial session after the participant completes the outcome measures and is evaluated by a licensed physical therapist.

Participants will be involved in the study over a 4 week period. Each participant will be asked to attend 4 sessions, with one week in between each session as follows: Week 0 = baseline assessment and treatment 1; Week 1= treatment 2; Week 2 = treatment 3; and week 4 = follow-up assessment.

After completion of the baseline assessment, qualified participants will be randomly assigned to either a supine or prone thoracic spine thrust manipulation intervention.

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
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Between 20 and 50 years of age (inclusive)
  • •Primary complaint of neck pain with or without symptoms that spread down into one arm
  • •Overall rating of neck pain intensity is at least 3/10; the overall rating is the average of the participant's rating of current, least, and worst pain experienced over the previous 24 hours on separate numeric pain rating scales where 0 corresponds to "no pain" and 10 corresponds to "worst possible pain"
  • •Neck Disability Index (NDI) score > 10 points (measure of self-reported disability with a 0 to 50-point scale where higher scores indicate higher levels of disability)
  • •Proficient in speaking and reading English to complete outcome questionnaires

排除标准

  • •Neck pain related to a motor vehicle accident or other trauma within the previous 6 weeks
  • •Neck pain that spreads down into both arms
  • •Low back pain or thoracic origin of pain
  • •Nerve root involvement; defined as the presence of two or more neurological findings (e.g., decreased strength, diminished deep tendon reflex, or decreased sensation) at the same nerve root level
  • •Diagnosis of cervical spinal stenosis (narrowing of the central canal that contains the spinal cord)
  • •History of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
  • •Pending legal action related to current episode of neck pain
  • •Contraindications to thoracic spine thrust manipulation
  • •serious pathologies or conditions (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, history of prolonged steroid use)
  • •hyperreflexia
  • •unsteadiness during gait
  • •loss of visual acuity
  • •impaired sensation of the face
  • •altered taste
  • •the presence of pathological reflexes
  • •pregnancy or considering pregnancy

研究组 & 干预措施

Supine thoracic spine manipulation

Active Comparator

Supine thoracic spine thrust manipulation (lying face-up on the treatment table) will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2)

干预措施: Supine thoracic spine thrust manipulation (Other)

Seated thoracic spine manipulation

Active Comparator

Seated thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2).

干预措施: Seated thoracic spine thrust manipulation (Other)

结局指标

主要结局

Numerical Pain Rating Scale (NPRS)

时间窗: Change in NPRS scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)

Each participant's neck pain intensity will be assessed by use of the Numeric Pain Rating Scale (NPRS of 0-10)

Neck Range of Motion

时间窗: Change in Neck ROM at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)

Cervical range of motion measured with the Goniometer

Neck Disability Index (NDI)

时间窗: Change in NDI at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)

The Neck Disability Index (NDI) is a self-reported measure of disability consisting of a 0-50 point scale where higher scores indicate higher levels of disability

Shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH)

时间窗: Change in QuickDASH scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)

The shortened version of the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire is a self-report measure of function that can assess how neck pain may be impacting daily activities that require use of the upper limb

次要结局

未报告次要终点

研究者

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

Tarang Jain

Assistant Professor - Physical Therapy and Athletic Training

Northern Arizona University

研究点 (1)

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