The Effect of Integrating Pain Neuroscience Education(PNE) With Conventional Physiotherapy on Pain and Functional Disability in Patients With Acute Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Oswestwry Disability Index
研究概览
简要总结
Acute low back pain is one of the most common health problems in the world. Most people experience it at least once in their lives, and although many cases improve within a few weeks, a significant number of patients continue to struggle with pain, fear of movement, stress, and reduced daily function. These psychological factors-such as catastrophizing ("my back is damaged"), fear of movement ("if I move, it gets worse"), and avoidance behaviors-can slow recovery and increase the risk of the pain becoming chronic.
Pain Neuroscience Education (PNE) is a modern educational approach that teaches patients how pain actually works in the nervous system. Instead of focusing only on muscles and bones, PNE helps people understand how the brain interprets pain, why pain can persist even without serious injury, and how thoughts, emotions, and behaviors can influence the experience of pain. Research shows that PNE can reduce fear, improve movement, and help people participate better in rehabilitation-especially in chronic pain. However, there is very limited high-quality evidence about its effects in acute low back pain.
The purpose of this study is to determine whether adding Pain Neuroscience Education to routine physiotherapy can improve recovery in people with acute low back pain.
To do this, the investigators will conduct a single-blind randomized clinical trial with two groups of patients:
Control group: Receives conventional physiotherapy, including soft-tissue mobilization and TENS, along with routine patient education about posture and back care.
Intervention group: Receives the same physiotherapy plus two structured sessions of Pain Neuroscience Education, delivered individually using simple explanations, metaphors, and visual materials.
Both groups will receive eight treatment sessions over four weeks.
The investigators will measure several important outcomes before starting treatment and immediately after the 8th session, including:
Pain intensity
Functional disability
Pain catastrophizing
Fear-avoidance beliefs
Fear of movement (kinesiophobia)
The investigators' hypothesis is that patients who receive PNE in addition to routine physiotherapy will show greater reductions in pain, disability, fear, and catastrophizing compared to those receiving physiotherapy alone.
If proven effective, this approach could provide a simple, low-cost, and safe addition to physiotherapy that not only reduces pain but also prevents acute low back pain from turning into a chronic condition. This could help improve patients' quality of life and reduce the economic and healthcare burden caused by low back pain.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and older.
- •A primary complaint of acute low back pain (defined as pain between the bottom of the ribs and the gluteal fold), with or without leg pain.
- •Pain duration of less than 6 weeks.
- •Absence of any "red flags" for serious spinal pathology (e.g., tumor, infection, fracture, cauda equina syndrome), as confirmed by an orthopedist or neurologist.
排除标准
- •Low back pain lasting more than 3 months (chronic low back pain).
- •History of spinal surgery within the past 3 years.
- •Inability to read or understand Persian.
- •Diagnosed cognitive impairments.
- •Unwillingness to continue the treatment or study protocol.
- •Diagnosed rheumatic, neurological, cardiac, metabolic, or respiratory diseases.
- •Diagnosis of fibromyalgia, chronic fatigue syndrome, loss of skin sensation, or skin inflammation/swelling in the low back area.
- •Presence or emergence of any "red flag" condition.
- •Missing more than 3 consecutive treatment sessions.
- •Previous participation in Pain Neuroscience Education sessions.
研究组 & 干预措施
"Conventional Physiotherapy Plus Pain Neuroscience Education (PNE)"
干预措施: routine physiotherapy + traditional patient education (Other)
"Conventional Physiotherapy Plus Pain Neuroscience Education (PNE)"
干预措施: pain neuroscience education (Behavioral)
"Conventional Physiotherapy With Routine Back-Care Education"
干预措施: routine physiotherapy + traditional patient education (Other)
结局指标
主要结局
Oswestwry Disability Index
时间窗: first session (day 1), end of 8th session (4 weeks)
Functional disability was assessed using the Oswestry Disability Index (ODI), a questionnaire scored from 0 to 100%, where 0 indicates no disability and 100 indicates maximum disability. Higher scores reflect greater levels of disability.
Visual Analog Scale
时间窗: first session (day 1), end of 8th session (4 weeks)
Pain intensity was assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain intensity.
次要结局
- Tampa Scale Of Kinesiophobia(first session (day 1), end of 8th session (4 weeks))
- Fear Avoidance Beliefs Questionnaire(first session (day 1), end of 8th session (4 weeks))
- Pain Catastrophizing Scale(first session (day 1), end of 8th session (4 weeks))