Additional Effects of Pain Neuroscience Education With Standard Pre-operative Physiotherapy on Post-laminectomy Pain and Disability.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Neuropathic Pain
研究概览
简要总结
This randomized controlled trial investigates whether adding Pain Neuroscience Education (PNE) to standard pre-operative physiotherapy improves outcomes after lumbar laminectomy. Chronic low back pain often involves central sensitization, where the nervous system continues amplifying pain signals even after the structural problem is surgically corrected, contributing to persistent neuropathic pain and disability after spine surgery.
The study will enroll 44 male and female patients aged 35-60 scheduled for elective one- or two-level lumbar laminectomy, with a pre-surgical waiting period of at least three weeks. Participants will be randomized into two equal groups. The experimental group will receive a three-week "nervous system priming" program: three 45-minute sessions combining PNE (explaining pain biology and neuroplasticity through culturally adapted metaphors) with standard exercises (ankle pumps, quad sets, gluteal sets, isometric abdominal sets, heel slides, and walking), plus a home program. The control group will receive identical standard exercises and session structure, but without PNE, using placebo counselling instead.
Outcomes will be measured using the painDETECT questionnaire (neuropathic pain) and the Oswestry Disability Index (functional disability), assessed at baseline, three weeks post-operatively, and three months post-operatively. The study will run for seven months following ethical approval.
The research addresses a gap in current perioperative care, which is typically reactive and rarely incorporates neurophysiological education into prehabilitation. If PNE proves effective, it could reduce post-laminectomy neuropathic pain and disability, decrease dependency on painkillers and prolonged rehabilitation, and inform more effective pre-surgical protocols for spine surgery patients.
详细描述
Background and Rationale
Lower back pain affects roughly 37% of the adult population, with 60-85% of people experiencing it at some point in their lives. Lumbar laminectomy and hemilaminectomy are the standard surgical treatments for spinal stenosis and disc herniation causing radiculopathy. However, even with technically successful decompression surgery, a substantial number of patients continue to experience neuropathic pain, chronic post-surgical pain, and ongoing disability - a pattern sometimes classified as Failed Back Surgery Syndrome.
A key driver of this persistent pain appears to be central sensitization: a state in which the nervous system becomes hypersensitive and continues amplifying pain signals even after the original tissue damage has been surgically addressed. In effect, the body's "alarm system" stays active long after the danger has passed, and fear-avoidance behaviors driven by this sensitization can further entrench chronic pain. Most current pre-operative care models are reactive and, where prehabilitation exists, it typically consists of generic exercise programs that do not address these underlying neurophysiological mechanisms.
Pain Neuroscience Education (PNE) is an evidence-based approach that helps patients understand that their pain reflects a sensitized nervous system rather than ongoing tissue damage. This understanding can reduce fear and catastrophizing and activate the brain's own pain-inhibiting pathways. While PNE has shown benefit when combined with exercise for chronic low back pain in several trials and meta-analyses, no standardized protocol currently integrates PNE into a cohesive pre-surgical (rather than purely conservative) program for laminectomy patients. This study is designed to fill that gap.
Significance
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 (Participant)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients
- •Adults aged 35-60 years.
- •Scheduled for elective, primary 1- or 2-level lumbar laminectomy/decompression for radiculopathy due to stenosis or herniation.
- •A pre-surgical waiting period of at least 3 weeks.
- •Able to understand and provide informed consent in Urdu/English.
排除标准
- •Severe cognitive impairment
- •Unstable medical conditions
- •Lower limb or spinal fractures or severe joint deformities
- •Previous lumbar spine surgery.
- •Cauda equina syndrome or other surgical emergencies.
- •Major systemic illness (e.g., uncontrolled cardiovascular disease, cancer) or psychiatric disorder that would limit participation.
- •Non-ambulatory status prior to surgery
- •Significant Neural deficit after surgery
研究组 & 干预措施
Group 1(Standard pre-op physiotherapy+neuroscience education)
干预措施: Experimental Group - Pain Neuroscience Education + Standard Pre-operative Protocol (Procedure)
Group 2 (standard pre-op physiotherapy)
干预措施: Control Group - Standard Pre-Operative Care (Procedure)
结局指标
主要结局
Neuropathic Pain
时间窗: 3 weeks
Neuropathic pain will be assessed using the pain DETECT Questionnaire, a 9-item screening tool with 85% specificity for identifying neuropathic pain components. Scores below 12 indicate the neuropathic component is unlikely, 13-18 suggest it's possible, and 19 or higher indicates it is highly likely present. Assessments will occur at baseline, 3 weeks post-operatively, and again at 3 months to track sustained effects.
Neuropathic Pain
时间窗: 3 months
Neuropathic pain will be assessed using the pain DETECT Questionnaire, a 9-item screening tool with 85% specificity for identifying neuropathic pain components. Scores below 12 indicate the neuropathic component is unlikely, 13-18 suggest it's possible, and 19 or higher indicates it is highly likely present. Assessments will occur at baseline, 3 weeks post-operatively, and again at 3 months to track sustained effects.
Disability
时间窗: 3 weeks
Functional disability will be measured using the Oswestry Disability Index (ODI), a 10-item questionnaire with excellent reliability (ICC \>0.90) and validity. Each section scores 0-5, with total percentage scores interpreted as: 0-20% minimal disability, 21-40% moderate, 41-60% severe, 61-80% crippled, and 81-100% bed-bound. A change of 10 points or more is considered the minimally clinically important difference (MCID). ODI will also be assessed at baseline, 3 weeks post-operatively, and 3 months post-operatively.
Disability
时间窗: 3 months
Functional disability will be measured using the Oswestry Disability Index (ODI), a 10-item questionnaire with excellent reliability (ICC \>0.90) and validity. Each section scores 0-5, with total percentage scores interpreted as: 0-20% minimal disability, 21-40% moderate, 41-60% severe, 61-80% crippled, and 81-100% bed-bound. A change of 10 points or more is considered the minimally clinically important difference (MCID). ODI will also be assessed at baseline, 3 weeks post-operatively, and 3 months post-operatively.
次要结局
未报告次要终点