Cognitive Functional Therapy (CFT) Compared With a Combined Manual Therapy and Motor Control Exercise in Patients With Non-specific Chronic Low Back Pain: a Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
There is evidence, of a single randomized controlled trial, that CFT is better than combined manual therapy and motor control exercise for chronic low back pain. However, this study had significant methodological shortcomings regarding the failure to carry out the intention to treat analysis and a considerable loss of follow-up of patients. It is important to replicate this study through a randomized clinical trial with similar objectives in another domain, but correcting these methodological shortcomings. Therefore, the aim of the study is to assess the efficacy of Cognitive Functional Therapy in patients with chronic non specific low back pain.
详细描述
One hundred and forty eight patients with chronic low back pain from two outpatient physiotherapy clinics in Brazil will be randomized to receive either Cognitive Functional Therapy or combined Manual Therapy and Motor Control Exercises. Intervention: 4-10 sessions of CFT. Control: 4-10 sessions of combined Manual Therapy and Motor Control Exercises. Measurements: Clinical outcomes will be assessed at the baseline, 3 months, 6 months and 12 months after randomization. Analysis: Intention-to-treat analysis will be performed, and linear mixed models will be calculated to evaluate the effect of the intervention. Non-specific predictors, moderators and mediators of outcome will also be analysed. Discussion: This study will investigate whether the results of the first CFT clinical trial can be replicated. In addition, the results will contribute to a better understanding of the efficacy of the CFT approach.
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 (Participant, Outcomes Assessor)
盲法说明
Clinical outcomes will be obtained in the evaluations carried out by a blinded assessor 3, 6 and 12 months after randomization. Both arms include active treatments, and participants will not know whether they are in the experimental group or control group.
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
- •Aged between 18 and 65 years
- •Low back pain for more than 3 months
- •Disability score of 14% or more on the Oswestry Disability Index (ODI)
- •Being able to walk independently with or without support
- •Understand Portuguese well enough to be able to fill in the questionnaires
排除标准
- •Main pain area is not the lumbar spine (from T12 to buttocks)
- •Main pain as leg pain (eg: nerve root compression or herniated disc with radicular pain / radiculopathy, lateral and central stenosis)
- •Less than 6 months after lumbar spine, lower limb or abdomen surgery
- •Invasive procedures for pain relief (ex: epidural injection, rhizotomy) in the last 3 months
- •Pregnancy
- •Inflammatory/rheumatological diseases (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, systemic lupus erythematosus, Scheuermann's disease)
结局指标
主要结局
Pain intensity
时间窗: 3 months after randomization
It will be measured by the Brazilian version of the Numerical Scale of Pain 11 points (END). The END scale goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last seven days
Disability associated to low back pain
时间窗: 3 months after randomization
It will be assessed by the Brazilian version of the Oswestry Disability Index (ODI). It is a tool widely used in research and clinical practice to assess the disability low back pain. This questionnaire has 10 items (0-5 points each) related to activities of daily living that patients with low back pain have more difficulties to do. The sum of the scores of items is multiplied by two and the percentage of disability varies from 0 to 100 %.
次要结局
- Pain intensity(6 and 12 months after randomization)
- Disability associated to low back pain(6 and 12 months after randomization)
- Patient Satisfaction(3, 6 and 12 months after randomization)
- Global impression of recovery(3, 6 and 12 months after randomization)
研究者
Ney Armando Meziat Filho
Professor
Centro Universitário Augusto Motta