跳至主要内容
临床试验/NCT04054869
NCT04054869Unknown不适用

Bio-mechanical Reasoning and Lateral Specificity of Upper Cervical Joint Mobilization to Improve Cervical Rotation, Improve Function and Reduce Pain.... Does it Matter?

Andrews University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年11月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
15
试验地点
2
主要终点
intra-visit change in cervical active range of motion rotation

研究概览

简要总结

Participants with limited neck rotation are recruited to determine if manual therapy (joint stretching) techniques applied in a bio-mechanically correct sequence will improve neck motion, function and pain better than if the manual therapy is applied in the opposite direction. Each participant will receive both the correct and the incorrect applications in randomized order with each treatment separated by 2-3 days. Improvement in neck motion, function and pain will be assessed after each session.

详细描述

Participants are recruited consecutively through referral from provider clinics or through self referral to physical therapy in the outpatient rehabilitation clinic at Indiana University Health West Hospital in Avon Indiana. After obtaining informed consent and meeting study criteria, participants will be randomized into either first receiving atlanto-axial joint mobilizations in a bio-mechanically correct or incorrect direction with respect to their loss of cervical rotation. Outcome measures will be completed both pre and post treatment. The participants will then be given self stretches at home to mimic the same intervention performed in the clinic three times per day. The participants will then return to the clinic in two or three days to receive the opposite treatment and opposite home program. Outcome data will again be collected both pre and post treatment. Participants will return for a final visit in two or three days and final outcome data will be collected and the participant will be offered continuation of physical therapy if neck symptoms still persist.

Planned Statistical Analysis:

  • Descriptive statistics of subjects: age, gender, date of onset, Neck Disability Index, cervical active range of motion rotation, initial numeric pain rating at rest and rotating to the limited side
  • Repeated measures ANOVA effect sizes for comparing differences between:
  1. Pre and post treatment comparing with-in treatment change for cervical range of motion rotation and numeric pain ratings on 1st and 2nd visits. Also comparing post treatment in cervical range of motion rotation and numeric pain ratings between 2nd and 3rd visits.
  2. Neck disability index change between 1st and 2nd visits and 2nd and 3rd visits
  • Power calculation (actual achieved power)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

participants and the outcomes assessor will be masked (blinded) as to the order in which each participant receives the interventions

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • males or females between 18 and 80 years of age
  • 25 percent or greater asymmetry of active cervical range of motion rotation limited by pain and/or stiffness

排除标准

  • cervical surgeries or injections in the past one year
  • current manual or exercise treatment by another provider for neck pain
  • cervical manipulation/mobilization/trauma in past 3 months
  • cervical radicular or referred pain distal to the acromion
  • upper extremity neurologic myotome weakness or constant dermatomal numbness
  • pending litigation
  • signs of cervical myelopathy or vertebrobasilar artery insufficiency
  • use of prescribed anticoagulants or documented blood clotting disorder
  • alar or transverse ligament instability

结局指标

主要结局

intra-visit change in cervical active range of motion rotation

时间窗: day 1: pre and post treatment change, day 3: pre and post treatment change

measured by standard goniometry

次要结局

  • inter-visit change in neck disability/function(change between day 1 and day 3, change between day 3 and day 5)
  • intra-visit change in cervical pain at rest(day 1: pre and post treatment change, day 3: pre and post treatment change)
  • intra-visit change in cervical pain during most restricted active rotation(day 1: pre and post treatment change, day 3: pre and post treatment change)

研究者

发起方
Andrews University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael J Williams

Physical Therapist

Andrews University

研究点 (2)

Loading locations...

相似试验