Cognitive Functional Therapy (CFT) Compared With a Combined Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Non-specific Chronic 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
- 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. As it is, it is important to carry out more studies involving CFT compared to other interventions already used in clinical practice and to correct 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
Randomized controlled trial with concealed allocation, blinded assessor, blinded participants and intention to treat analysis. Patients will be evaluated at baseline, 8 weeks, 6 and 12 months after randomization, to assess the maintenance of any effect of treatment. The patients in the CFT group will be treated by a physical therapists that attended twice the CFT workshops with two of the tutors of the method. She completed 106 hours of training including workshops, patient examinations and a pilot study with the supervision of a physical therapist with more than three years of clinical experience in CFT. Patients in CORE-MT group will be treated by a physical therapist with clinical experience in manual therapy and core training exercises.
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 8 weeks, 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: 8 weeks
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: 8 weeks
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
- Global impression of recovery(8 weeks, 6 and 12 months after randomization)
- Pain intensity(6 and 12 months after randomization)
- Disability associated to low back pain(6 and 12 months after randomization)
- Patient Satisfaction (mediator of outcome)(8 weeks, 6 and 12 months after randomization)
- Catastrophization (mediator of outcome)(8 weeks, 6 and 12 months after randomization)
- Depression (mediator of outcome)(8 weeks, 6 and 12 months months after randomization)
- Fear of movement (mediator of outcome)(8 weeks, 6 and 12 months months after randomization)
- Stress (mediator of outcome)(8 weeks, 6 and 12 months months after randomization)
- Sleep (mediator of outcome)(8 weeks, 6 and 12 months months after randomization)
研究者
Ney Armando Meziat Filho
Assistant Professor, Rehabilitation Sciences
Centro Universitário Augusto Motta