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临床试验/NCT02420106
NCT02420106已完成不适用

Effect of Osteopathic Manipulative Medicine on Motor Function and Quality of Life in Cervical Dystonia

New York Institute of Technology2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年2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
入组人数
10
试验地点
2
主要终点
Change in Motor Function

研究概览

简要总结

The purpose of the proposed research is to determine if Osteopathic manipulative medicine (OMM) used alone or in combination with the standard treatment of botulinum toxin intramuscular injections improves motor function and quality of life amongst people with cervical (neck) dystonia.

详细描述

Cervical dystonia, also called spasmodic torticollis, is a type of neurological disorder characterized by spastic muscles in the neck that is largely underdiagnosed despite its progression to disability during midlife. Cervical dystonia occurs in at least 0.390% of the United States population in 2007 (390 per 100,000). Symptoms commonly include stiffness, pain, headaches, difficulty swallowing, fatigue, and difficulty walking. The current standard treatment is intramuscular botulinum toxin injection every 90 days. The effect of the botulinum toxin increases gradually, and then it decreases until there is little to no effect at 90 days post-injection. The purpose of the proposed research is to determine if Osteopathic manipulative medicine (OMM) used in combination with the standard treatment of botulinum toxin intramuscular injections improves motor function and quality of life amongst people with cervical dystonia.

The investigators propose to use Vicon 3-dimensional gait and posture analysis to determine the biomechanics of subjects with primary cervical dystonia to compare with full body complaints from a standard spasmodic torticollis/cervical dystonia questionnaire as well as the osteopathic structural exam. These measures will be assessed before and after four OMM treatments. In addition, the investigators propose to use osteopathic manual medicine along with botulinum toxin injection to improve the subjects' pain and motor function as evaluated by Vicon 3-dimensional gait and posture analysis and questionnaire regarding quality of life. Preliminary case reports suggest that Osteopathic manipulative medicine without botulinum toxin injections improved pain, posture, gait, and quality of life in four adult subjects as well as improved head tilt in two children (two- and five-years old). The central hypothesis is that osteopathic manual medicine will significantly improve the range of motion, motor function, and quality of life of subjects with primary cervical dystonia.

Aims:

Aim I. To determine 3-Dimensional gait and posture biomechanics of subjects with untreated primary cervical dystonia while walking, and to investigate the effectiveness of OMM in treating abnormal biomechanics in these subjects.

Hypothesis I: People with cervical dystonia have similar abnormalities in posture and structural exam that significantly alters their gait and full body motor function that can be significantly improved with OMM.

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
2 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of cervical dystonia or spasmodic torticollis
  • ages 2-100

排除标准

  • no clinical diagnosis of cervical dystonia or spasmodic torticollis
  • symptoms beginning over the age of 40
  • pregnant women are excluded from Aim 2

研究组 & 干预措施

OMM alone

Active Comparator

Subjects who are not receiving botulinum treatment consenting to Osteopathic Manipulative Medicine intervention

干预措施: Osteopathic Manipulative Medicine (Procedure)

OMM plus Botulinum

Active Comparator

Subjects who are receiving botulinum treatment and will have osteopathic manipulative medicine intervention.

干预措施: Osteopathic Manipulative Medicine (Procedure)

结局指标

主要结局

Change in Motor Function

时间窗: baseline and 5 weeks

Motor function will be assessed by Vicon 3-Dimensional analysis of the subjects' biomechanics while walking and will depict stride length and arm swing on each side of the body as well as the posture of the shoulder and pelvic girdle with reference to the coronal, transverse and sagittal planes.

次要结局

  • Change in Quality of Life(baseline and 5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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