Comparison of the Efficacy of Electrical Dry Needling Versus Traditional Physical Therapy in the Treatment of Active Myofascial Trigger Points in Pain, Sensitivity, Functionality and Quality of Life of Patients With Chronic Non-specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in pressure pain threshold by Wagner manual pressure algometer.
研究概览
简要总结
The main objective of this study is to determine the efficacy of electrical dry needling versus ischemic compression, analytical stretching and postural habits educational dossier in active myofascial trigger points in patients with chronic non-specific low back pain.
详细描述
A double-blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients in the experimental group will receive electrical dry needling at the active myofascial trigger points (PGM) of the quadratus lumbar, multifidus, and iliocostal muscles (following the PGM maps described by Travell and Simons). The technique will be performed using needle electrodes, the generated current will be produced by a TENS device with a frequency of 2 Hz and a pulse width of 250 μs, during 30 min of application. The therapeutic intervention will be 1 weekly session for a total of 6 weeks.
The control group will perform an ischemic compression technique in active PGM with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifidus and iliocostal muscles. The treatment will consist of 1 weekly session for 6 weeks, in addition they will be provided with a training dossier on postural education in their activities of daily life.
A baseline assessment of the primary and secondary outcome measures will be carried out before randomization of the participants to the different groups, an immediate post-treatment assessment (1 day after the last intervention) and an assessment two month after the end of the intervention ( short-term follow-up).
The objectives of this study are to compare the repercussions of dry electropuncture versus ischemic compression in active PGM plus stretching in terms of pain, functionality, mobility of the spine, and quality of life in patients with non-specific chronic low back pain; and analyze the impact on active myofascial trigger points in terms of pressure tolerance threshold.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Low back pain ≥ 3 months.
- •Age between 30 and 67 years old.
- •Not being receiving physical therapy.
排除标准
- •Presence of lumbar stenosis.
- •Diagnosis of spondylolisthesis.
- •Diagnosis of fibromyalgia.
- •Treatment with corticosteroids or oral medication in recent weeks.
- •History of spine surgery.
- •Contraindication of analgesic electrical therapy.
- •Have previously received a treatment of electrical analgesia or exercise.
- •Central or peripheral nervous system disease.
结局指标
主要结局
Changes in pressure pain threshold by Wagner manual pressure algometer.
时间窗: At baseline, at 6 weeks and at 2 months
Apply the tip of the algometer perpendicular to the muscle and maintain a pressure, which will gradually increase to 1 kg / sec. Subjects will be instructed to signal the moment they experience pain, in order to have an accurate record (pain threshold).
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
时间窗: At baseline, at 6 weeks and at 2 months
This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.Ranging from 0 points- better to 24 points- worse disability
次要结局
- Change from baselina in range of motion(At baseline, at 6 weeks and at 2 months)
- SF-36 Health Questionnaire (SF-36).Change from baseline on Quality of Life.(At baseline, at 6 weeks and at 2 months)
- Changes in pressure pain threshold by Wagner manual pressure algometer.(At baseline, at 6 weeks and at 2 months)
- Change from Mcquade Test.(At baseline, at 6 weeks and at 2 months)
- Tampa Scale of Kinesiophobia (TSK).Change from baseline in Fear of Movement.(At baseline, at 6 weeks and at 2 months)
- Change from baseline in pain intensity. Visual analogue scale(At baseline, at 6 weeks and at 2 months)
- Change from insomnia Severity Index Índice de calidad de sueño de Pittsburgh.(At baseline, at 6 weeks and at 2 months)
- Change from baseline in disability. Oswestry Low Back Pain Disability Idex.(At baseline, at 6 weeks and at 2 months)
- Change from baseline in lumbar mobility flexion.(At baseline, at 6 weeks and at 2 months)
研究者
Adelaida María Castro-Sánchez
Principal Investigator
Universidad de Almeria