Effectiveness of Percutaneous Neuromuscular Electrical Stimulation on Lumbar Multifidus in Combination With a Protocol of Motor Control Exercises in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Increased cross-sectional area in activation
研究概览
简要总结
Chronic low back pain is a common musculoskeletal condition affects the general population. Low back pain constitutes a major burden to health care system and society. Several authors have found that the deep abdominal muscles and multifidus are affected in low back pain. Dry needling has shown improve the cross-sectional area of the multifidus. Percutaneous electrical nerve stimulation has shown reduce pain in several conditions. There are not studies that had investigated the impact of percutaneous neuromuscular electrical stimulation (PNMES) in the deep muscles in patients with chronic low back pain.
Hypothesis: PNMES in the multifidus muscle plus motor control exercise program in patients with chronic low back pain is better than sham PNMES plus exercise and transcutaneous electrical nerve stimulation (TENS) plus exercise
详细描述
Randomized, double-blind, placebo controlled clinical trial, using percutaneous neuromuscular electrical stimulation (PNMES). PNMES is technique to provide a transcutaneous electrical nerve stimulation current throughout needling filaments place close to the nerve.
Study Aims:
Aim #1: The primary aim of the study is to compare the effect of the short, medium and long-term of PNMES on muscle activation (increased cross-sectional area in activation) and the function of multifidus and abdominal transverse muscle in patients with chronic low back pain with random assignment to four treatments: PENS plus motor control exercise program or Sham PNMES (introducing the needle) plus motor control exercise program or Transcutaneous Electrical Nerve Stimulation (TENS) plus motor control exercise program or Sham PNMES (without inserting the needle) plus motor control exercise program.
Aim #2: The secondary aim of the study is to compare the effect of the short, medium and long-term of PNMES on pain as measured by visual analogue scale (VAS), chronic Pain Grade Questionnaire, pressure pain threshold (PPT), area and distribution of pain, conditioned pain modulation and temporal summation in patients with chronic low back pain with random assignment to four treatments: PNMES plus motor control exercise program or Sham PNMES (introducing the needle) plus motor control exercise program or Transcutaneous Electrical Nerve Stimulation (TENS) plus motor control exercise program or Sham PNMES (without inserting the needle) plus motor control exercise program.
Aim #3: To compare the effect of the short, medium and long-term of PNMES on disability as measured by Oswestry Disability Index, strength and quality of life with random assignment to four treatments: PENS plus motor control exercise program or Sham PNMES (introducing the needle) plus motor control exercise program or Transcutaneous Electrical Nerve Stimulation (TENS) plus motor control exercise program or Sham PNMES (without inserting the needle) plus motor control exercise program.
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)
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
- •Low back pain more than 90 days of evolution
排除标准
- •Spondylarthrosis
- •History of fractures, luxations, surgery and/or musculoskeletal disorders in low back and lower limb.
- •Leg pain or neuropathic pain (LANSS <12).
- •Neurological disorders, inflammatory and/or degenerative diseases.
- •Having received as treatment techniques that involve needles on the previous 6 months to study enrollment or having received percutaneous electrical stimulation as a treatment before.
- •Physiotherapy treatment in the last 4 weeks.
- •Specific lumbar pathology, fibromyalgia, unstable cardiovascular diseases, pregnant women or under suspect of pregnancy.
- •Contraindications of needle's insertions: anticoagulant therapy, needle phobia, diabetes, hypothyroidism, lymphoedema, muscular diseases).
- •Contraindications of electrical current.
- •Drugs: morphine or opioids drugs.
- •Depression
- •Judicial dispute
结局指标
主要结局
Increased cross-sectional area in activation
时间窗: Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
The increase in height from the resting position to the submaximal contraction in the lumbar multifidus will be measured
Changes in the measurements of the multifidus and tranverse of the abdomen at rest.
时间窗: Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
Changes in the height of the multifidus at rest
次要结局
- Intensity of Pain((Baseline, one hour from baseline after PNMES treatment 1 (only at rest), 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline)
- Pressure pain threshold using an algometer(Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline)
- Temporal summation(Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline)
- Conditioned pain modulation(Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline)
- Pain Grade Questionnaire(Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline)
- Oswestry Disability Index or Oswestry Low Back Pain Disability Questionnaire(Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline)
- Short form 12 (SF-12) health survey (health-related quality of life)(Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline)
- Kinesiophobia(Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline)
- Pain catastrophizing(Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline)
- The Becks Depression Inventory-II(Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline)
- Anxiety(Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline)
- Global Rating of Change Scale(Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline)
- Blinding the patient(1 hour from baseline after the PNMES treatment 1, 2 weeks from baseline after the second PNMES treatment and 4 weeks from baseline after the third PNMES treatment)
- Central Sensitization Inventory(Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline)
研究者
Josue Fernandez Carnero
PhD
Universidad Rey Juan Carlos