Efficacy of Education on Neurophysiology of Pain Combined to Hypnosis in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain Numerical Rating Scale
研究概览
简要总结
Although education on neurophysiology of pain improves disability, there are limited effects in pain intensity. Hypnosis is an approach that has proven useful in pain intensity and psychosocial aspects in some chronic pain conditions, but there is insufficient evidence of its contribution in patients with chronic non specific low back pain. The aim of the study is to assess the efficacy of combining education on neurophysiology of pain and hypnosis in patients with chronic non specific low back pain in pain and disability outcomes.
详细描述
Introduction: Education on pain neurophysiology has beneficial effects on disability and psychosocial aspects in patients with non specific chronic low back pain. However, education has limited effects in pain. Hypnosis is an approach that has proven efficient in pain intensity and psychosocial aspects in some chronic pain conditions, but there is insufficient evidence of its contribution in patients with non specific chronic low back pain.
Objectives: The aim of the study is to assess the efficacy of combining education on neurophysiology of pain and hypnosis in patients with non specific chronic low back pain in pain and disability outcomes.
Study design: randomized controlled trial with two arms and blinded evaluator. Local study: Interventions will be held at the Universidade Cidade de Sao Paulo (UNICID).
Participants: One hundred patients with chronic non specific low back pain who are on the waiting list for physical therapy care at UNICID physical therapy clinic, interested and eligible for the study will be invited to participate.
Intervention: Patients will be randomized to the education group about pain neurophysiology or to a group that combines education with hypnosis.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non specific chronic low back pain, defined as pain or discomfort between the coastal margins and lower gluteal folds, with or without symptoms related to lower limbs for at least three months, of both genders, aged between 18 and 80 years and literate in Portuguese.
排除标准
- •Patients with back pain by nerve root compromise, serious spinal pathologies (such as fracture, tumor, inflammatory and infectious diseases), cardio-respiratory and uncompensated metabolic diseases, previous back surgery , pregnancy, presence of some contraindications to exercise, and have a hearing or understanding problem that prevents the understanding of simple information.
研究组 & 干预措施
Education combined with hypnosis
Patients will receive 4 sessions (1 hour each) of education on pain neurophysiology combined with hypnosis.
干预措施: education combined with hypnosis (Other)
Education
Patients will receive 4 sessions (1 hour each) of education on pain neurophysiology.
干预措施: education (Other)
结局指标
主要结局
Pain Numerical Rating Scale
时间窗: 2 weeks after randomization
It is a translated and adapted scale for the Portuguese language that assesses pain intensity levels perceived by patients through a 11-point scale (ranging from 0 to 10), with 0 being classified as "no pain" and 10 "worst pain possible ". Patients will be asked to mark the level of the average pain intensity and the more intense based on the last seven days.
Roland Morris Disability Questionnaire
时间窗: 2 weeks after randomization
This questionnaire consists of 24 items describing everyday situations that patients may have difficulty in performing because of back pain. The greater the number of alternatives completed affirmatively, the greater the level of disability associated with lombar pain. Patients will be instructed to fill out the statements that actually describe their situation on the day of the interview. It's tool was already translated and adapted for the Portuguese language.
次要结局
- The Pain Catastrophizing Scale (PCS)(2 weeks and 3 months after randomization)
- The Patient-Specific Functional Scale(2 weeks and 3 months after randomization)
- Global Perceived Effect Scale(2 weeks and 3 months after randomization)
- Roland Morris Disability Questionnaire(3 months after randomization)
- Pain Numerical Rating Scale(3 months after randomization)
研究者
Rodrigo Rossi Nogueira Rizzo
PT, MSc Student
Universidade Cidade de Sao Paulo