Effectiveness of Group Versus Individual Pain Neuroscience Education on Clinical and Psychosocial Outcomes in Patients With Chronic Low Back Pain: Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 69
- 主要终点
- Changes in Fear avoidance beliefs
研究概览
简要总结
An educational intervention on the neurophysiology of chronic pain will be provided. The content of the intervention will be identical in the experimental groups (group and individual). The intervention has an active educational approach based on reconceptualizing the maladaptive beliefs that influence the fear-avoidance behavior of the participants through updated contents of the neuroscience of pain.
The effects of the intervention will be compared between the groups and the influence of the social determinants of health on the effects will also be determined.
The investigators hypothesize that there will be significant differences in favor of the group intervention group over the individual intervention groups. Furthermore, the effects will be influenced by the social determinants of health in both experimental groups.
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)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-specific low back pain ≥ 3 months without compromise of any lower limb.
- •average pain intensity ≥ 3/10 and ≤8/10 (according to the 0-10 numerical rating scale [NRS]) in the last month.
排除标准
- •psychiatric, neurological or oncological diseases.
- •operated of some lumbar pathology
- •chronic low back pain due to a specific cause (lumbar stenosis, herniated disc, spinal deformity, fracture, spondylosis)
- •have received any modality of active or passive physical therapy for pain in the last two months,
- •previous experiences with PNE
研究组 & 干预措施
Group Pain Neuroscience Education
A single face-to-face group session of approximately 60-80 minutes provided through active participation. Five key domains will be structured from the Fear and Belief Avoidance Questionnaire that will serve as a guide for the sessions through a Powerpoint presentation. In addition, participants will be encouraged to be active by walking for 20-30 minutes 3-5 times a week and will be taught an exercise to improve transverse abdominis activation (abdominal corset or follow-through).
With the main ones, a brochure will be delivered and informative capsules will be made to which the participants will have access (5 videos of 15 minutes, one per domain). Participants will be instructed to record on a calendar the days they read the brochure and/or reviewed the information capsules to assess treatment compliance and for each domain invent a metaphor or script for how they would explain it to another person. This activity must be delivered in the second evaluation.
干预措施: Pain neuroscience Education (Other)
Individual Pain Neuroscience Education
A single one-on-one face-to-face session of approximately 60-80 minutes provided through active participation. Five key domains will be structured from the Fear and Belief Avoidance Questionnaire that will serve as a guide for the sessions through a Powerpoint presentation. In addition, participants will be encouraged to be active by walking for 20-30 minutes 3-5 times a week and will be taught an exercise to improve transverse abdominis activation (abdominal corset or follow-through).
With the main ones, a brochure will be delivered and informative capsules will be made to which the participants will have access (5 videos of 15 minutes, one per domain). Participants will be instructed to record on a calendar the days they read the brochure and/or reviewed the information capsules to assess treatment compliance and for each domain invent a metaphor or script for how they would explain it to another person. This activity must be delivered in the second evaluation.
干预措施: Pain neuroscience Education (Other)
Control
no intervention
结局指标
主要结局
Changes in Fear avoidance beliefs
时间窗: baseline, 1-week post-intervention, and 4 -weeks post-intervention
The Fear Avoidance Beliefs Questionnaire consists of two subscales: (1) a 7-item work subscale (FABQ-W) and (2) a 4-item physical activity subscale (FABQ-P). Both subscales score on a Likert-type scale from 0 to 6 points on each item. Higher scores indicate higher levels of fear-avoidance beliefs.
changes in pressure pain sensitivity
时间窗: baseline, 1-week post-intervention, and 4 -weeks post-intervention
An algometer will be used to measure pressure pain sensitivity (SPD), which is defined as the amount of applied pressure required for a subject to report the onset of pain sensation. It will be applied three times for each moment of evaluation and the average of the three applications will be considered. The unit of measure kg/cm2/s will be used.
次要结局
- Changes in Catastrophizing(baseline, 1-week post-intervention, and 4 -weeks post-intervention)
- Changes in Pain Self-efficacy(baseline, 1-week post-intervention, and 4 -weeks post-intervention)
- Treatment expectation(baseline)
- Changes in Pain intensity(baseline, 1-week post-intervention, and 4 -weeks post-intervention)
研究者
Joaquín Ignacio Salazar Méndez
adjunct teacher
Universidad Santo Tomas, Chile