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临床试验/NCT04892550
NCT04892550Unknown不适用

The Addition of a Sagittal Thoracic Posture Corrective Orthotic Device to a Multimodal Rehabilitation Program Improves Management Outcomes in Patients With Chronic Nonspecific Neck Pain: A Randomized-controlled Trial.

Cairo University0 个研究点目标入组 80 人开始时间: 2021年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
主要终点
Change in thoracic kyphosis

研究概览

简要总结

Because changes in sagittal thoracic alignment have been reported to alter the mechanical loading of the cervical spine and decreased thoracic mobility has been identified as one of the predictors for neck and shoulder pain , it makes sense that thoracic articular treatment improves local kinematics and simultaneously neck pain improves. The purpose of this study is to investigate the effects of a multimodal program, with thoracic hyper kyphosis rehabilitation using the Denneroll™ thoracic traction orthosis , applied to participants with chronic non-specific neck pain and thoracic hyper-kyphosis.

详细描述

Interventions directed at improving hyper-kyphosis of the thoracic spine may have therapeutic effects on the cervical spine; however, there is a lack of controlled studies evaluating this. The purpose of this study is to investigate the effect effects of a multimodal program, with thoracic hyper kyphosis rehabilitation using the Denneroll™ thoracic traction orthosis , applied to participants with chronic non-specific neck pain and thoracic hyper-kyphosis.

In this study, 80 participants, with chronic non-specific neck pain and thoracic hyper-kyphosis will be included. Participants will be randomly assigned to the control or an intervention group. Both groups will receive the multimodal program; additionally, the intervention group received the Denneroll™ thoracic traction orthosis. Outcome measures will include kyphotic angle (max.), neck pain and disability , sensorimotor control outcomes; head repositioning accuracy , smooth pursuit neck torsion test and overall stability index . Measures will be assessed at three intervals: baseline, 10 weeks, and 6 months after cessation of treatment.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • neck pain for more than 3 months
  • thoracic angle measured more 55 degrees

排除标准

  • Any signs or symptoms of medical "red flags",
  • a history of previous spine surgery.
  • signs or symptoms of upper motor neuron disease.
  • vestibulobasilar insufficiency.
  • amyotrophic lateral sclerosis.
  • bilateral upper extremity radicular symptoms.

结局指标

主要结局

Change in thoracic kyphosis

时间窗: pre-treatment , at 10-week post treatment ,and at 6-month follow up

Thoracic kyphosis was assessed using a 4D formetric device where determination of thoracic kyphosis angle is measured between tangents from the cervicothoracic junction and that of the thoracolumbar junction

次要结局

  • change in neck disability index(pre-treatment , at 10-week post treatment ,and at 6-month follow up)
  • Change in Postural Stability(pre-treatment , at 10-week post treatment ,and at 6-month follow up)
  • Change in numerical rating score(pre-treatment , at 10-week post treatment ,and at 6-month follow up)
  • Change in head and eye movement control: smooth pursuit neck torsion test(pre-treatment , at 10-week post treatment ,and at 6-month follow up)
  • Change in cervical joint position sense testing(pre-treatment , at 10-week post treatment ,and at 6-month follow up)

研究者

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

Ibrahim Moustafa

Associate professor

Cairo University

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