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临床试验/NCT02433821
NCT02433821已完成3 期

Effectiveness of Pilates to Treat Mechanical Neck Pain

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2012年2月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Change in pain

研究概览

简要总结

The neck pain comes from disturbances related to the cervical spine, of multifactorial origin and is considered a frequent problem of disability.

Pilates is a physical conditioning method that has been widely used to improve posture and develop body awareness.

The aim of this study is to assess the impact of the Pilates method in the control of pain, function and quality of life in patients with chronic mechanical neck pain.

Methods: 64 patients with chronic mechanical neck pain will be selected and randomized into two groups: intervention and control. Both groups will be assessed for pain, function, quality of life and medication intake.

The intervention group will hold Pilates sessions for three months, with two sessions per week. The control group will continue with the usual drug treatment. Both groups will be instructed to use 750mg acetaminophen every 6 hours if there is pain, but consumption of the drug will be controlled.

Although the symptoms of neck pain are common in the population, no study has investigated the effects of the Pilates method as a possible treatment for neck pain. The hypothesis is that the Pilates method can offer benefits to these patients.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •People with diagnosis of chronic mechanical neck pain and symptoms of pain in the lower region of spine, between the occipital and the first thoracic vertebra, for more than three months.
  • •Pain between 3 and 8 on the numerical pain scale
  • •Age between 18 and 65
  • •Both genders
  • •Agree to take part in the study and sign the terms of agreement

排除标准

  • •Fibromyalgia
  • •Previous traumatic injuries in the spine
  • •Infections and inflammation in the spine cervical pain radiating to upper limbs
  • •The practice of physical activity started or altered in the last 3 months
  • •Visual deficiency not corrected by glasses, disturbance in the central nervous system, hearing deficiency making the use of the method impossible.

研究组 & 干预措施

Pilates Group

Experimental

The group will realize 2 classes per week, lasting one our, of Pilates under supervision of a trained instructor. The training program will last 3 months.

干预措施: Pilates (Other)

Control group

No Intervention

The patients will keep the drug treatment and will be keep in a waiting list. After the 180 days of study the will be invited to realize the Pilates training.

结局指标

主要结局

Change in pain

时间窗: Baseline, after 45, 90 and 180 days

Evaluated by visual analogue scale (VAS) from 0 to 10

次要结局

  • Change in function(Baseline, after 45, 90 and 180 days)
  • Change in Quality of life(Baseline, after 45, 90 and 180 days)
  • Change in medication intake(After 45, 90 and 180 days from baseline)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luciana de Araujo Cazotti

Principal Investigator

Federal University of São Paulo

研究点 (1)

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