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
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
- 否
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
Pierre Balthazard
Bachelor of sciences in physical therapy
University of Applied Sciences of Western Switzerland
