Comparing Effectiveness Two Intratissue Percutaneous Electrolysis (EPI) Interventions for Chronic Low Back Pain: Lumbar Nerve Root Stimulation vs Trigger Points Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change from baseline in Algometry
研究概览
简要总结
The main objective of this study is to analyze the effectiveness of the lumbar nerve root stimulation with ultrasound-guided percutaneous electrolysis versus the electrical dry needling of trigger points in patients with chronic low back pain.
详细描述
Given that recently the effectiveness of intratissue percutaneous electrolysis (EPI) has become of interest in the treatment of chronic musculoskeletal pain, when conventional physiotherapy management is not successful, the EPI can promote the healing biological processes. Several studies have demonstrated that inflammation can play an important role in the progression of muscle degeneration, in addition to potentially contributing to painful symptoms in individuals with chronic low back pain.
This technique involves nonthermal, electrochemical ablation of the lesion via the use of a cathodic fluid. The inflammation provoked is very localized and healing is rapid. Although EPI has been widely employed lately, the literature contains few studies validating its use.
The good results reported in studies of tendinopathies have to the undertaking of the present work, which compares the long-term effectiveness of EPI and dry needling-both ultrasound-guided-for the treatment of chronic low back pain.
A double blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients of experimental group will receive 1 weekly sessions of intratissue percutaneous electrolysis for 3 weeks, for a total of 3 sessions. The aim is to compare the effectiveness of applying percutaneous electrolysis in the lumbar nerve root versus applying electrical dry needling on trigger points of the gluteus medius, quadratus lumborum, and erector spinae muscles (6 sessions, once a week) on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility and muscular electrical activity.
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.
- •Score ≥ 4 points on the Roland Morris Disability Questionnaire.
- •Not being receiving other 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 intratissue percutaneous electrolysis.
- •Central or peripheral nervous system disease.
结局指标
主要结局
Change from baseline in Algometry
时间窗: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
An instrument for measuring the degree of sensitivity to pain. We will carry out a location of the myofascial trigger points following the illustrations of location of the myofascial trigger points that indicate Travell and Simons of both the left and right hemibody. Once located they will be classified as active or latent. Measured in kg / cm 2 with an analog pressure algometer model Wagner FDK20. To carry out this diagnosis using the analog pressure algometer, a force of 1Kg / sec will be applied until the subject indicates with a "YA" presence of pain, at that time we will stop the pressure made with the analog pressure algometer and record the result. The measurement will be executed 3 times with a 30 sec rest between each measurement and an average of the 3 results obtained will be obtained. Myofascial trigger points that do not meet the above criteria will be considered latent and which will not be subject to any treatment.
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
时间窗: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
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.
次要结局
- Change from baseline in disability. Oswestry Low Back Pain Disability Idex.(At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.)
- Change from baseline in pain intensity. Visual analogue scale.(At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.)
- Change from baseline in Quality of Sleep . Pittsburgh Quality of Sleep Questionnaire Index(At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.)
- Change from Mcquade Test.(At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.)
- Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.(At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.)
- Change from baseline on Quality of Life. SF-36 Health questionnaire.(At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.)
- Change from baseline in range of motion and lumbar segmental mobility(At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.)
- Change from baseline in Fingers-floor distance (cm)(At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.)
- Change from baseline in Anxiety. Hospital Anxiety and Depression Scale (HADS)(At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.)
研究者
Adelaida María Castro-Sánchez
PhD
Universidad de Almeria