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临床试验/NCT02245425
NCT02245425已完成不适用

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

A.T. Still University of Health Sciences1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年9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
已完成
入组人数
21
试验地点
1
主要终点
Numeric Pain Rating Scale (NPRS)

研究概览

简要总结

This study is designed 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 people with neck pain.

The null hypothesis is that there will be no differences between the two manipulation techniques for short-term effects on neck range-of-motion, pain, and self-reported disability in people with neck pain.

详细描述

Patients 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.

Patients who meet the inclusion/exclusion criteria will be randomized 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
22 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Between 22 and 50 years of age
  • •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 overall 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 pain possible".
  • •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 spine 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 (lying face-up on the treatment table) thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2)

干预措施: Supine Thoracic Spine Manipulation (Other)

Prone Thoracic Spine Manipulation

Active Comparator

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

干预措施: Prone Thoracic Spine Manipulation (Other)

结局指标

主要结局

Numeric Pain Rating Scale (NPRS)

时间窗: Baseline (Week 0)

Patient-rated assessment of pain on scale of 0-10

Neck ROM

时间窗: Change from Baseline (Week 0) to Follow-up (Week 3) and between Week 1 and Week 3

Cervical rotation and lateral flexion measured with goniometer.

Shortened Version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH)

时间窗: Baseline (Week 0)

11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.

NPRS

时间窗: Change from Baseline (Week 0) and Follow-up (Week 3) and From Week 1 and Week 3

Patient-rating of pain on a scale of 0-10

Neck Disability Index (NDI)

时间窗: Baseline (Week 0)

10 Question patient-rated outcome measures specific to neck disability

NDI

时间窗: Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3

10 Question patient-rated outcome measures specific to neck disability

QuickDASH

时间窗: Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3

11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.

Neck Range of Motion (ROM)

时间窗: Baseline (Week 0)

Cervical rotation and lateral flexion measured with goniometer.

NPRS

时间窗: Change from Week 0 to Week 1

Patient-rating of pain on a scale of 0-10

NDI

时间窗: Change from Baseline (Week 0) to Week 1

10 Question patient-rated outcome measures specific to neck disability

QuickDASH

时间窗: Change from Week 0 to Week 1

11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.

Neck ROM

时间窗: Change from Baseline (Week 0) to Week 1

Cervical rotation and lateral flexion measured with goniometer.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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