The Effects of a Single Session of Pain Neuroscience Education (PNE) on Pain and Psychological Factors in Patients With Chronic Low Back Pain. A Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 2
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
One of the treatment modalities currently available in this hospital to treat this type of patients with low back pain who present with chronic pain are the group sessions that are carried out to provide information to the patient about the anatomy, biomechanics and ergonomics and are complemented with sessions of physical exercise. Based on the latest publications on treatment of this type of patients, The investigators have seen that this intervention is insufficient, and that it could be improved by combining education based on Pain Neuroscience Education (PNE)).
The present study proposes implementing this program to a randomly assigned group of patients participating in the group sessions aimed at patients with lumbar pain called "Back-pain Protocol" that are currently relized in the Physiotherapy Area of a hospital; and compare the results of this intervention with those obtained in another group that will only carry out the sessions with the traditional method that is currently used.
详细描述
Procedure The physiotherapist in charge of the chronic back pain programme group ("back pain protocol") is contacted. The study will be explained and the materials and training to deliver the PNE session will be provided.
Participants who meet the inclusion criteria will then be identified and randomised to the intervention or control group.
At the end of the first session, which currently takes place in group chronic back pain treatment programmes, the physiotherapist will explain the study and ask for cooperation. The information sheet is handed out. Those who decide to participate will receive an informed consent form and some questionnaires to fill in: the Numeric Pain Rating Scale (NPRS) to assess their level of pain, the Central Sensitisation Inventory, the Pain Catastrophic Scale (Spanish version), the Tampa Kinesiofobia Scale (TSK).
Interventions The current protocol consists of five sessions spread over one and a half months. Patients come to the rehabilitation classroom in two groups of 10 people per day for one hour.
The first session consists of an informative talk. The physiotherapist gives information and explanations about the "back pain protocol". The physiotherapist explains the problems of posture and gestures that can be beneficial or detrimental to their treatment, their daily activities, their work and their sporting activities.
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
Participants receive TEN sessions, but do not know that one of the groups will receive extra information
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
- •Patients participating in the "back protocol" groups in the hospital
- •That present pain of more than 3 months of evolution
排除标准
- •Oncological pain
- •Fracture or spinal surgery in the last year
- •Cognitive neurological alteration that prevents understanding the contents of the session
- •Alterations at the motor level that prevent the realization of the program of directed physical exercise that is currently carried out
- •Pregnancy
- •Urinary or intestinal incontinence
- •Other clinical conditions that may aggravate chronic spinal pain (chronic fatigue syndrome, fibromyalgia and complex regional pain syndrome)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: 6 weeks following the reported onset of symptoms.
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
次要结局
- - Central sensitisation inventory (CSI)(baseline, 5 weeks and 12 weeks)
- Pain Catastrophizing: Pain Catastrophizing Scale(baseline, 5 weeks and 12 weeks)
- Kinesiophobia: Tampa Scale for Kinesiophobia (TSK 11)(baseline, 5 weeks and 12 weeks)
研究者
María Isabel Tomás Rodríguez
Principal Investigator
Universidad Miguel Hernandez de Elche