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临床试验/NCT01899469
NCT01899469已完成不适用

Efficiency of Physiotherapy Treatments for Low Back Pain in Women.

University Rovira i Virgili2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2012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
96
试验地点
2
主要终点
Oswestry disability index (ODI)

研究概览

简要总结

Aim: To evaluate and compare the effectiveness of a combined treatment of TENS or Elec-tromagnetic and Back School with the effectiveness of only the Back School treatment.

Design: Single-blind experimental prospective study of clinic intervention. Setting: Physiotherapy and Speech Therapy Unit at the Cambrils Slight Hospital. Spain.

Population: 96 women (50-85 years) with chronic low back pathology. Methods: Subjects were divided into three randomized groups: Back School (group 1), TENS with Back School (group 2), and Magnetic therapy with Back School (group 3). They have re-ceived 20 sessions of treatment. The intensity of pain (EVA Scale) and the quality of life (Oswestry Scale) were measured, at the beginning and at the end of the treatment and after three and six months. Anthropometric and physical activity variables were collected.

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 (Participant)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between 50 and 85 years.
  • Chronic LBP condition for at least three months ago.
  • Patient's agreement by signing the consent.

排除标准

  • Cardiac pacemaker carriers.
  • Patients with parts of osteosynthesis and / or prostheses.
  • Patients with a not well balanced medical condition.
  • Patients with TENS at home and / or having completed physiotherapy during the last three months.
  • Patients with skin infectious diseases or skin lesions and / or areas of hypoesthesia.
  • Patients with malignant tumours.
  • Patients who received any spinal injection during the last six weeks.
  • Patients who participate or have participated in a study in the last three months

结局指标

主要结局

Oswestry disability index (ODI)

时间窗: 24 weeks

. The ODI assesses nine different aspects of disability, affecting various functions of daily life (personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). The questionnaire is scored using a global percentage score. For every section, one of six options is chosen. Each section is scored 0-5, with 0 indicating no limitation of function due to pain, and with 5 indicating major functional disability due to back pain.

Pain was measured at the beginning and after the treatment with the Visual Scale Analogue (VAS)

时间窗: 24 weeks

The VAS scale represents the pain intensity on a line of 10 cm, at one end there are the words "no pain" and the other end "the worst imaginable pain " written, the distance in centimetres from the "no pain" point to the place marked by the patient represents the intensity of pain

次要结局

  • Questionnaire of Physical Activity (ClassAF)(4 weeks)

研究者

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

Marta Romeu Ferran

SD

University Rovira i Virgili

研究点 (2)

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