Osteopathic Manipulative Treatment Associated With Education About Pain and Clinical Hypnosis and Their Repercussions on Pain and Disability in Chronic Low Back Pain - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain pressure threshold
研究概览
简要总结
INTRODUCTION: Chronic low back pain (CLBD) is one of the major public health problems in the world. Given the complexity of the situation, complementary and alternative practices such as pain neuroscience education (PNE), clinical hypnosis (HC) and osteopathic manipulative treatment (OMT) are options for we manage these patients. OBJECTIVE: The aim of this study will be to evaluate the effects of OMT associated with PNE through HC on pain and disability in patients with CLBP compared to PNE and HC. MATERIALS AND METHODS: The study design will be a randomized clinical trial and 40 adults diagnosed with chronic low back pain will be recruited. Subjects will be randomized in two groups: the first group (G1) will be submitted to the PNE based on information from the book "Explain Pain" with hypnotic suggestions. Group 2 (G2) will receive PNE following the book "Explain Pain" with hypnotic suggestions associated with OMT. Volunteers will be evaluated by a blind researcher the interventions performed in the allocation of groups. The evaluation moments will be pre-intervention and immediately after the end of the last intervention for G1 and G2. Volunteers continued to be evaluated 4 weeks after completion of the protocols. Pain will be evaluated as the main outcome, being evaluated by the numerical pain scale. Pain will also be assessed by the pressure threshold using a pressure algometer device (Fnd-50, PIAB 50-n, Italy) in the lumbar region. Still as the main outcome, disability will be assessed using the Oswestry Disability Questionnaire. As secondary outcomes, the patient's global impression of improvement, central sensitization, biopsychosocial factors will be evaluated. The patient's global impression of improvement will be assessed using the Percentage of Improvement Scale with a score of -5 to +5; the Central Sensitization will be assessed using the Central Sensitization Questionnaire and the biopsychosocial factors using the Start Beck Toll questionnaire. In addition, the behavior of the autonomic nervous system will be evaluated through the Heart Rate Variability (HRV), which will be analyzed through linear methods, in the domains of time and frequency, and by geometric indices. The researcher/evaluator will be blinded to the allocation of intervention groups. Given the nature of the study, it is impossible to blind the researcher/therapist and volunteers.
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)
盲法说明
A simple randomized sequence will be created through the website www.randomization.com by a collaborator external to the researchers directly involved in the research. After the initial assessment, the researcher will access the randomization envelope and the participant will be allocated to 1 of the 2 treatment groups. The allocation will be hidden using opaque envelopes, sealed, and identified by number. The researcher/evaluator will be blinded to the allocation of intervention groups. Given the nature of the study, it is impossible to blind the researcher/therapist and volunteers
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nonspecific Low Back Pain for at least 3 months
- •Score on the numerical pain scale of at least 3 points
排除标准
- •Data from participants with less than 95% of sinus beats
- •Participants that present increased symptoms in any stages of the study
- •Patients who are undergoing concomitant physical therapy treatment, patients with contraindications to exercise, smokers/alcoholics, severe vertebral or neural pathologies, previous spine surgeries, cardiorespiratory disease, LBP as a secondary complaint, pregnancy, hearing problems, or illiteracy patients, not will are able to participate the protocol.
结局指标
主要结局
Pain pressure threshold
时间窗: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
Pain will be assessed by the pressure threshold using a pressure algometer device in the lumbar region. The assessment will be conducted specifically in the paravertebral muscles bilaterally at levels L1 to L5.
Pain perception
时间窗: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
The Pain suffered in the last week will be assessed by the Numerical pain scale, with a range of 0 - 10
Disability
时间窗: T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols
Disability will be assessed using the Oswestry Disability Questionnaire
次要结局
- Central Sensitization and biopsychosocial factors(T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols)
- Heart Rate Variability(T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols)
- Patient's global impression of improvement(T0= before the protocol; T1= until 24 hours after the end protocol; T2= four weeks after end protocols)