The Effectiveness of Neuroscience Pain Education Combining Manual Therapy in Patients with Chronic Low Back Pain: a Single-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Numeric pain rating scale (NPRS)
研究概览
简要总结
The cognitive educational strategies such as neuroscience pain education, has been a popular and promising technique for treatment patients with chronic pain. However, there are not sufficient randomized controlled and blinded studies to explore clinical effectiveness of these techniques. Therefore, the aim of this study was determining the short- and mid-term effects of neuroscience pain education combined with manual therapy and home exercise on pain level, disability, and kinesiophobia in patients with chronic low back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Volunteered to participate in the study.
- •Patients with 18-65 years
- •Had low back pain for at least 6 months,
- •Reported pain severity of 5 or greater according to the numeric pain rating scale
- •Used pregabalin and gabapentin derivatives,
排除标准
- •Previous spine or lower extremity surgery
- •Severe osteoporosis
- •Spondyloarthropathy
- •Spondylolisthesis
- •Lumbar stenosis
- •Systemic inflammatory diseases
研究组 & 干预措施
Neuroscience pain education group
in Group 1, participants received Neuroscience pain education, manual therapy and a home exercise program.
干预措施: manual therapy (Other)
Neuroscience pain education group
in Group 1, participants received Neuroscience pain education, manual therapy and a home exercise program.
干预措施: neuroscience pain education (Other)
Neuroscience pain education group
in Group 1, participants received Neuroscience pain education, manual therapy and a home exercise program.
干预措施: home exercises (Other)
Manual therapy group
in Group 2, participants received manual therapy and a home exercise program.
干预措施: manual therapy (Other)
Manual therapy group
in Group 2, participants received manual therapy and a home exercise program.
干预措施: home exercises (Other)
Control group
in Group 3, participants received home exercise program only.
干预措施: home exercises (Other)
结局指标
主要结局
Numeric pain rating scale (NPRS)
时间窗: Change from Baseline NPRS at 4th weeks and 12th weeks
The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale from 0 to 10. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme.
次要结局
- Oswestry Disability Index (ODI)(Change from Baseline ODI at 4th weeks and 12th weeks)
- Back Performance Scale (BPS)(Change from Baseline BPS at 4th weeks and 12th weeks)
- Tampa Scale for Kinesiophobia (TSK)(Change from Baseline TSK at 4th weeks and 12th weeks)
研究者
Ismail Saracoglu
Principle Investigator
Kutahya Health Sciences University