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临床试验/NCT01314157
NCT01314157已完成不适用

Evaluation of Isostretching Effects in Patients With Mechanical and Postural

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
2
主要终点
Evaluation of isostretching effects in patients with chronic low back pain

研究概览

简要总结

Isostretching is effective in treating chronic back pain to improve pain, quality of life and functional capacity.

详细描述

Objective

This study investigated the influence of isostretching on patients with chronic low back pain. Methods: It was a randomized, controlled trial with concealed allocation, intention-to-treat analysis, and blind assessment. Fifty-four patients with chronic low back pain were randomized to an experimental group and a control group. The experimental group performed isostretching twice a week for 45 days, while the control group remained on the waiting list for physical therapy. Patients were submitted to evaluations at baseline, after 20 and 45 days of treatment with regard to pain, quality of life, functional capacity, and satisfaction. Results: The experimental group exhibited statistically significant improvements in comparison to the control group with regard to pain (p = .003), functional capacity (p = .026), patient satisfaction (p < .001), and quality of life as determined by the functional capacity (p = .012), physical aspects (p = .011) and pain (p = .006) subscales of the SF-36. The experimental group used a significantly lesser amount of pain medication than the control group (p = .03). Conclusion: Isostretching was effective in reducing pain and in improving function, patient satisfaction and some aspects of quality of life in patients with chronic low back pain.

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
Double (Care Provider, Outcomes Assessor)

盲法说明

Os pacientes selecionados foram alocados de forma aleatória através da lista de randomização gerada por computador, foram confeccionados envelopes lacrados e opacos utilizados para manter o segredo de alocação. Todos foram submetidos à avaliação inicial (T0), com 20 dias (T20) e com 45 dias (T45), por um avaliador cego.

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

入选标准

  • Individuals diagnosed with chronic low back pain with pain located between the last rib and the gluteal fold over 12 weeks;
  • Mechanical back pain that worsens with exertion and relieved by rest;
  • Pain between 3 and 8 cm measured by analog pain scale.

排除标准

  • Subjects who presented pain root
  • Fibromyalgia
  • Severe scoliosis with abnormal alignment of the spine (Cobb angle> 40); Tumors in the column; Infiltration in the lumbar spine in the last three months; Previous surgery of the spine (patients return to work or process expulsion)
  • Have changed or initiated physical activity in the last three months
  • Body mass index greater than 30 kg/m2

结局指标

主要结局

Evaluation of isostretching effects in patients with chronic low back pain

时间窗: 1 month

Reviewed by analog pain scale. (VAS)

次要结局

未报告次要终点

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

Erika Rosangela Alves Prado

Mestra em Ciências da Saúde Aplicada a Medicina Reumatológica

Federal University of São Paulo

研究点 (2)

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