Dry Needling Versus Percutaneous Electrolysis in Lumbar Multifidus Muscles in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain intensity. Visual analogue scale.
研究概览
简要总结
The aim of this study is to evaluate the reduction of pain of two different treatments in patients with chronic low back pain. Patients were divided in two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles.
详细描述
Background: Low back pain is one of the most common health problems and a leading cause of disability and absence from work. Between 70% and 80% of adults will experience an episode of low back pain and approximately 10.0% of them will become chronic. This has a direct impact on the lumbar stabilizing muscles, giving rise to both structural and functional changes. Among the different treatment options, it has been observed that both dry needling (DN) and percutaneous electrolysis (PE) are effective techniques in the management of musculoskeletal pain.
Aim: To evaluate whether the reduction of pain after the application of PE is superior to the one obtained with DN.
Methods: A single-blind randomized clinical trial will be conducted in patients with chronic low back pain. The subjects will be divided into two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles. The study variables will be: pain (VAS), disability index (Oswestry Scale), fear of movement (TSK-11SV) and quality of life (SF-12). The measurements will be assessed before, right after and 7 days after a single intervention.
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, Outcomes Assessor)
盲法说明
40 sealed opaque envelopes will be prepared. 20 of the envelopes will contain ballots corresponding to the DN control group and 20 to the PE group. Only the examiner who will carry out the intervention will know the group of each participant. The main examiner will be the one who monitors the intervention without knowing which group each participant belongs to.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low back pain ≥ 3 months.
- •Age between 30 and 60 years old.
- •Not being receiving other physical therapy
排除标准
- •Diagnosis of specific lumbar pathology.
- •History of previous lumbar surgery.
- •Treatment with corticosteroids, anti-inflammatory or antibiotic medication in recent weeks.
- •Oncological processes, febrile symptoms or thrombophlebitis.
- •Skin conditions.
- •Belonephobia.
- •Pacemaker.
- •Pregnancy.
- •Patients with neurological pathology
结局指标
主要结局
Pain intensity. Visual analogue scale.
时间窗: At baseline, at 1 week after the last intervention, and 6-month follow-up period
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain
次要结局
- Disability. Oswestry Low Back Pain Disability Idex(At baseline, at 1 week after the last intervention, and 6-month follow-up period)
- Quality of life. SF-12 Health questionnaire.(At baseline, at 1 week after the last intervention, and 6-month follow-up period)
- Fear of Movement. Tampa Scale of kinesiophobia (TSK-11SV)(At baseline, at 1 week after the last intervention, and 6-month follow-up period)
研究者
Leire López de Calle Sánchez
Leire López de Calle Sánchez
University of Alcala