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临床试验/NCT01496144
NCT01496144已完成不适用

Manual Therapy Followed by Specific Active Exercises Versus a Placebo Followed by Specific Active Exercises on the Improvement of Functional Disability in Patients With Chronic Non Specific Low Back Pain: a Randomized Controlled Trial

University of Applied Sciences of Western Switzerland2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2005年12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
42
试验地点
2
主要终点
Visual Analogue Scale - VAS-pain

研究概览

简要总结

Background: Models have tried to explain the driving mechanisms behind chronic non specific low back pain (CNSLBP) in order to propose better appropriate conservative treatment. Altered responses at spinal and/or supraspinal level may affect the perception of pain and degree of disability of CNSLBP patients. Recent clinical recommendations still propose active exercises (AE) for CNSLBP. However, acceptance of exercises by patients may be limited by pain-related manifestations. Current evidences suggest manual therapy (MT) induces a short-term analgesic effect through neurophysiological mechanisms at peripheral, spinal and cortical levels. The aim of this study was first, to assess whether MT has an instant analgesic effect, and second, to compare the long-lasting effect on functional disability of MT followed by AE to sham therapy (ST) followed by AE. Methods: Forty-two CNSLBP patients without co-morbidities, randomly distributed into 2 treatment groups, received either spinal manipulation/mobilization (first intervention) plus AE (MT group; n = 22), or detuned ultrasound (first intervention) plus AE (ST group; n = 20). Eight therapeutic sessions were delivered over 4 to 8 weeks. Instant analgesic effect was obtained by measuring pain intensity (Visual Analogue Scale) before and immediately after the first intervention of each therapeutic session. Pain intensity, disability (Oswestry Disability Index) and fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire) were determined before treatment, after the 8th therapeutic session, and at 3- and 6-month follow-ups.

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 (Investigator, 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

入选标准

  • suffering from non specific low back pain with or without symptoms in the lower extremity for a period between 12 and 26 weeks
  • can maintain the usual medication

排除标准

  • spinal fracture or surgery within the previous 6 months
  • pregnancy
  • neoplasia
  • spinal infection
  • spinal inflammatory arthritis
  • low back pain of visceral origin
  • severe sensitive and/or motor radicular deficit from nerve root origin of less than 6 months
  • score of 3/5 or more on the Waddell Score
  • on sick leaves from work for 6 months or more
  • psychiatric disorders
  • opioid medication
  • patient unable to collaborate (linguistic barrier; cognitive impairments)
  • radiologic abnormalities other than degenerative disease
  • clinical neurogenic claudication.

结局指标

主要结局

Visual Analogue Scale - VAS-pain

时间窗: During treatment, over a period of 4 to 8 weeks

self-report of clinical pain intensity, consisting of a 10 cm horizontal line scale on which is added the statements "no pain" on the left and "maximum intensity of pain" on the right

次要结局

  • Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire - FABQ)(Before randomization and untill 6 months after the end of treatment)

研究者

发起方
University of Applied Sciences of Western Switzerland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pierre Balthazard

Bachelor of sciences in physical therapy

University of Applied Sciences of Western Switzerland

研究点 (2)

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