Back School or Brain School for Patients Undergoing Surgery for Lumbar Radiculopathy? A Randomized Controlled Trial With Two-year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Electrical pain threshold measured with an constant current electrical stimulator (DS7A Digitimer)
研究概览
简要总结
The primary scientific objective of the study entails examining whether perioperative pain neuroscience education (PPNE or 'brain school') is more effective than classical back school in reducing pain and improving pain inhibition in patients undergoing surgery for spinal radiculopathy. A secondary objective implies examining whether PPNE is more effective than classical back school in imparting a behavioural change (i.e. decreasing postoperative healthcare expenditure for lumbar radiculopathy), improving functioning in daily life and improving surgical experience (=better prepared for surgery, surgery meeting their expectations) in patients undergoing surgery for spinal radiculopathy.
详细描述
Prior to this study on lumbar radiculopathy patients, the proposed CPM protocol with EEG recordings will be pre-tested on a group of twenty healthy subjects, who will be fully informed about the study and subsequently gave their consent to participate. The proof of concept is set up to evaluate the effectiveness of the protocol, more specifically the appearance of nociceptive evoked potentials induced by electrical stimulation and the load on the subjects, as well as the safety of the protocol.
Low back pain is a frequently reported problem in our community. In the absence of successful outcomes following conservative intervention, surgery (including lumbar discectomy) is a recommended, evidence-based treatment for lumbar radiculopathy. To prevent chronicity following spinal surgery, preoperative education seems to be warranted. Current preoperative education programs in the orthopaedic and neurosurgical domain typically rely on the biomedical model, including education about (spinal) anatomy and biomechanics (like done in 'back schools'), as well as detailing the surgical procedure. Preoperative education focussing on the biomedical model is ineffective, and can increase anxiety and fear of patients undergoing spinal surgery. Therefore, there is a need to reconsider the content of education provided to patients undergoing spinal surgery.
Patient recruitment. All patients scheduled for surgery for lumbar radiculopathy in the UZ Brussel will be invited to participate. Lumbar radiculopathy is defined as pain due to lumbosacral nerve root compression. The NICE guidelines describe this as unilateral leg pain worse than the current back pain. This pain radiates to the foot or toes, and goes together with numbness and paraesthesia in the same distribution, which is associated with motor neurological deficit. Patients undergoing surgery for lumbar radiculopathy (n ≥ 100), willing to participate (including willingness to comply with the predetermined follow-ups), are recruited.
Randomization and concealment Randomization will be done by a computer-generated randomization list. A list with patient numbers and the group allocation that results from this randomization procedure will be stored in a sealed envelope. All the assessments will be performed by the same two investigators.
Intervention. At least 50 patients undergoing surgery for lumbar radiculopathy should get the experimental treatment, i.e. perioperative pain neuroscience education (PPNE). All patients will receive usual care plus surgery for lumbar radiculopathy. PPNE will comprise of two treatment sessions delivered by one physiotherapist (verbal one-on-one) and an educational booklet. The first treatment session will be in the week before surgery, the second on day 2 following surgery. Each treatment session will last approximately 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
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Surgery for radiculopathy
- •Speaking and reading Dutch fluently
- •18-65 years old
- •Continuing usual care ( no new treatment) 6 weeks preceding surgery and during trial
排除标准
- •Surgery for another condition than radiculopathy
- •Symptoms of cord compression
- •Rheumatoid, endocrinological, neurological or psychiatric disorder
- •Chronic illness characterized by chronic pain that is not under control
- •New treatments 6 weeks preceding surgery
- •Pregnancy (preceding year)
结局指标
主要结局
Electrical pain threshold measured with an constant current electrical stimulator (DS7A Digitimer)
时间窗: Change between baseline(1 week before surgery) and 3 days post-surgery, baseline and 6weeks post-surgery, baseline to 6 months post-surgery, baseline to 12 months post-surgery and baseline to 24 months post-surgery
Determination of the electrical pain threshold with an electrical stimulator at the Median Nerve and Sural Nerves of each patient.
Quantitative Electroencephalography (QEEG) for brain mapping
时间窗: Change between baseline(1 week before surgery) and 3 days post-surgery, baseline and 6weeks post-surgery, baseline to 6 months post-surgery, baseline to 12 months post-surgery and baseline to 24 months post-surgery
During the conditioned pain modulation a QEEG is administered to examine the differences in brain activation on the brain map between the time frames.
Self-reported pain assessed by the Visual Analogue Scale
时间窗: Change between baseline(1 week before surgery) and 3 days post-surgery, baseline and 6weeks post-surgery, baseline to 6 months post-surgery, baseline to 12 months post-surgery and baseline to 24 months post-surgery
Patients fill in the Visual Analogue Scale ( 0 no pain - 10 unbearable pain) for their perceived back and leg pain.
Endogenous pain inhibition assessed by the conditioned pain modulation paradigm
时间窗: Change between baseline(1 week before surgery) and 3 days post-surgery, baseline and 6weeks post-surgery, baseline to 6 months post-surgery, baseline to 12 months post-surgery and baseline to 24 months post-surgery
Conditioned pain modulation will be tested with the electrical stimulator as test stimulus and the cold pressor (12 °C) as conditioning stimulus. The difference between the electrical pain threshold (baseline) and the electrical pain threshold during the cold pressor (baseline + cold pressor) is called the conditioned pain modulation effect.
次要结局
- Functional status and well-being with the Short Form Health Survey-36 items(1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months)
- Pain hypervigilance with the Dutch Pain Vigilance and Awareness Questionnaire.(1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months)
- Kinesiophobia with the Tampa Scale for Kinesiophobia(1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months)
- Self-reported healthcare expenditure for which diaries will be used.(The difference between 3 days post-surgery, 6weeks post-surgery, 6 months, 12 months and 24 months)
- Surgical experience assessed with statements about patients their spinal surgery/education experience with a level of agreement on a numerical scale from 1 "minimal" to 10 "maximal agreement".(The difference between 3 days post-surgery, 6weeks post-surgery, 6 months, 12 months and 24 months)
- Postoperative healthcare expenditure for lumbar radiculopathy will be investigated by consultation of medical notes.(The difference between 3 days post-surgery, 6weeks post-surgery, 6 months, 12 months and 24 months)
- Pain catastrophizing with the Dutch translation of the Pain Catastrophizing Scale(1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months)
- Socio-economic factors with a demographic questionnaire concerning their return to work, professional occupation, incomes and grade of education.(1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months)