Effectiveness of Pain Neurophysiology Education in Chronic Low Back Pain: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
The investigators conducted a randomized controlled study including 22 patients suffering from chronic common low back pain. Patients were randomized into 2 groups: Control group received conventional rehabilitation only (11 patients) and PNE group received PNE combined with conventional rehabilitation (11patients). Outcome measures were pain, mobility of the lumbar spine, functional impairment, catastrophizing and kinesiophobia.
详细描述
The aim of our study was to compare the effectiveness of PNE in combination with conventional rehabilitation to the effectiveness of conventional rehabilitation alone in the management of patients with chronic low back pain, in terms of pain perception, functional capacity, and psychological well-being.
The inverstigators conducted a randomized controlled study, over a period of 3 months (from January 2024 to March 2024), in the rehabilitation and rheumatology department of Charles Nicolle Hospital in Tunis. Participants were informed about the nature of the study, and written informed consent was obtained from all participants prior to participation.
The study included patients aged 18 or older, suffering from chronic common low back pain.
The patients were randomized into 2 groups: control group who received conventional rehabilitation only and PNE group who received PNE combined with conventional rehabilitation.
Each patient, whether in control group or PNE group, underwent a total of 12 sessions, over a 4-week period, with a frequency of 3 sessions per week. Each session lasted 60 minutes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18 or older
- •patients suffering from chronic common low back pain
排除标准
- •acute and sub-acute low back pain
- •specific causes of low back pain with an identifiable cause (infectious, inflammatory, tumoral, etc.)
- •neurological complications associated with low back pain, such as cauda equina syndrome or muscle weakness.
- •history of lumbar surgery within the past 6 months
- •recent vertebral fractures
研究组 & 干预措施
control group
Conventional reeducation focused the first week on analgesic approach including:
- Education and lifestyle
- Massage and electrotherapy
- Pelvic and lumbar movement awareness
- Breathing exercises
Then in week 2 and beyond, physiotherapist continued analgesic work and physical training:
- Joint mobility and muscle flexibility
- Muscle strengthening
- Proprioceptive rehabilitation
干预措施: conventional rehabilitation (Procedure)
PNE group
Each session in PNE group began with 30 minutes of PNE and the last 30 minutes were devoted to conventional rehabilitation.
The program used for PNE was based on a brochure written in the Tunisian dialect with simple, patient-accessible language. The brochure includes different sections: definition of pain, origin of pain, types of pain, components of pain, role of nervous system in pain modulation and pain management. Thus, all main concepts of the neurophysiology of pain were explained and discussed using visual presentation.
At the end of the sessions, a test was provided to the patient to assess their understanding of the brochure's content.
At the follow-up session a month later, the main ideas taught were reinforced and any questions were answered.
干预措施: Pain Neurophysiology Education (Behavioral)
结局指标
主要结局
Pain intensity
时间窗: pain intensity was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).
Pain intensity was measured using the Visual Analog Scale (VAS) (0-10; with 0 representing no pain and 10 representing the worst pain)
次要结局
- Mobility of the lumbar spine(Mobility was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).)
- Functional impairment(Functional impairment was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).)
- Catastrophizing(Catastrophizing was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).)
- Kinesiophobia(Kinesiophobia was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).)
研究者
Selma Bouden
assistant doctor
Hopital Charles Nicolle