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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- Universidad Rey Juan Carlos
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Increased cross-sectional area in activation
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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
Detailed Description
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. Aim #4: To estimate the immediate effects of the PNMES technique after the first session. Aim #5: To determine if psychological factors (anxiety, depression, kinesiophobia and catastrophism) change with any of the treatments and if is related with the primary and secondary outcomes. Aim #6: To evaluate the change perceived by the patient measured with Global Rating of Change Scale (GROC). Aim Aim #7: Validation of placebo groups by assessing patient blindness
Investigators
Josue Fernandez Carnero
PhD
Universidad Rey Juan Carlos
Eligibility Criteria
Inclusion Criteria
- •Low back pain more than 90 days of evolution
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Increased cross-sectional area in activation
Time Frame: 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.
Time Frame: 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
Secondary Outcomes
- 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)