Association Between Tissue Changes in Lumbar Multifidae and Improvement in Pain and Disability After Dry Needling in Subjects With Nonspecific Low Back Pain. Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes from baseline in pain on the 10-point Visual Analog Scale (VAS, 0-10 score) at immediatelypost-needling and a week after.
研究概览
简要总结
Finding out if tissue changes (thickness, histogram and shrinkage rate) that occur in the lumbar multifidus after deep dry needling are related to changes in patient's pain and disability.
详细描述
Lower back pain in regarded as the main cause of disability in the world, which has a significant socio-economic impact. Deep dry needling is effective in handling such pain and is one of the techniques of choice by physiotherapists. In this area, the use of ultrasound provides information of interest such as length, thickness, diameter, cross-sectional area or muscle volume, among others.
Objective
Finding out if tissue changes (thickness, histogram and shrinkage rate) that occur in the lumbar multifidus after deep dry needling are related to changes in patient's pain and disability.
It's a double-blind randomized clinical trial in parallel groups. Patients will be randomly divided into 2 groups. One of them will receive dry needling and the other dry needling placebo. The initial, post-needling and a week after evaluations will be performed by a blinded to the intervention therapist.
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
- Double (Participant, Investigator)
盲法说明
Double-blind randomized clinical trial in parallel groups
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
- •Age between 18 and 65 years.
- •Nonspecific pain in the lumbar region.
排除标准
- •Previous surgery in the lumbosacral spine.
- •Osteoporosis.
- •Needle phobia.
- •Neurogenic pain with positive tests or negative symptoms.
- •Red flags: cauda equina syndrome, sudden weight loss, fracture, cancer, infection or systemic diseases.
- •Pregnancy.
- •Physiotherapy intervention in the 4 weeks prior to the intervention.
研究组 & 干预措施
Control group
Placebo dry needling
干预措施: Placebo dry needling (Other)
Experimental group
Dry needling
干预措施: Dry needling (Other)
结局指标
主要结局
Changes from baseline in pain on the 10-point Visual Analog Scale (VAS, 0-10 score) at immediatelypost-needling and a week after.
时间窗: Baseline, immediately post-needling and a week after.
This scale shows concurrent and predictive validity in the assessment of pain. A difference of 2 points represents a clinically significant change that exceeds the limits of measurement error.
次要结局
- Thickness of lumbar multifidus measured with Rehabilitive Ultrasound Imaging in millimeters(Baseline, immediately post-needling and a week after.)
- Pressure Pain threshold(Baseline, immediately post-needling and a week after.)
- Histograms using image analysis(Baseline, immediately post-needling and a week after.)
- Disability(Baseline, immediately post-needling and a week after.)
- Contraction time measured in milliseconds with M-mode(Baseline, immediately post-needling and a week after.)
研究者
Sebastián Rodríguez PosadaSebastián Rodríguez Posada
Principal investigator
University of Alcala