Additional Effect of Pain Neuroscience Education to Spinal Manipulative Therapy on Pain And Disability in Chronic Low Back Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Change in pain intensity after the end and at 1 month follow-up
研究概览
简要总结
Objectives: The primary objective will be to investigate the additional effect (immediate and after one-month follow up) of pain neuroscience education (PNE) to Spinal Manipulative Therapy (SMT) on primary outcomes of pain intensity and disability in patients with chronic nonspecific low back pain (CLBP).
详细描述
Design: This study will be a blinded randomized controlled clinical trial. Participants: One hundred and four participants with CLBP (18 and 55 years) both genders. Interventions: Individuals included will be randomized into two possible treatment arms: PNE+SMT or SMT alone. Each treatment will last for 8 sessions. The group submitted to PNE+SMT will received in the first two initial sessions an individual face-to-face PNE program of 40 minutes.Main outcome measures: Pain intensity and low back pain-related disability will be adopted as primary outcomes and as secondary outcomes we will assess fear-avoidance, pain self-efficacy and global perceived effect of improvement. The outcomes will be assessed on three occasions: pre-intervention, immediately after 8 sessions of intervention and after one-month follow-up period. All statistical analysis will be conducted following the principles of intention to treat, and the effects of treatment will be calculated using linear mixed models. Discussion: This study will help to better understand if PNE -a psychosocial cognitive intervention- will add significant effect (immediate and at follow-up) to a movement therapy protocol based on manual therapy.
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 (Investigator)
盲法说明
Once the patient has accepted the invitation to participate, the same researcher (FAGT) will gather the clinical assessment and determine eligibility. After this initial assessment, participants will be randomly assigned following simple computerized randomisation procedures to one of the two treatment groups through the use of cards previously placed in opaque sealed envelopes. The allocation sequence will be generated by a researcher (TCC) not involved in the assessment and interventions, and another research assistant will assign participants to interventions.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •who present chronic, non-specific, continuous and recurrent low back pain lasting at least three months and
- •contemplate at least three of the following criteria: 1-hip internal rotation with> 35 °; 2-lumbar spine hypomobility; 3-absence of distal knee symptoms and 4-point FABQ Work score 19.
排除标准
- •pregnant women;
- •red flags (neoplasia, vertebral column fracture, vertebral osteomyelitis, infection or equine tail syndrome, rheumatic diseases, diseases that compromise cognition);
- •disc herniation;
- •women in the luteal phase will be rescheduled;
- •patients with cognitive deficits evaluated according to the Mini Mental State Examination with score less than or equal to 24 points or 22 points (low education level) and
- •previous physical therapy for low back in the past year or submitted to any health/pain education strategy. Patients will be instructed to not use pain relief medications during the intervention period of this trial and if any medication be used, participants will be encouraged to report.
结局指标
主要结局
Change in pain intensity after the end and at 1 month follow-up
时间窗: Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-month follow-up.
The Numerical Pain Rating Scale (NPRS) used to assess pain intensity in this trial will consist in a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable".
Change in low back pain Disability after the end and at 1 month follow-up
时间窗: Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-month follow-up.
The Brazilian Portuguese version of Oswestry Disability Index (ODI) will be used to assess low back pain related disability. This instrument consists of 10 items, each of which has six response options. The total score will be calculated by summing up all the points, with the largest possible sum being 50. This sum will be transformed into a percentage by multiplying it by two.
次要结局
- Global Perceived Effect of treatment(Immediately after the end of the last session and after the one-month follow-up.)
- Change in Fear Avoidance Beliefs after the end and at 1 month follow-up(Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-month follow-up.)
研究者
Thais Cristina Chaves
Professor of the Department of Neurosciences and Behavioural Sciences of the Faculty of Medicine of Ribeirão Preto, University de São Paulo - FMRP/USP, Coordinator of the Laboratory of Research in Movement and Pain (LabMovPain)
University of Sao Paulo