Clinical trial NCT04243915: Percutaneous Neuromuscular Electrical Stimulation in Patients With Chronic Low Back Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Percutaneous neuromuscular electrical stimulation
Percutaneous electrical nerve stimulation
Percutaneous electrical stimulation
Motor control exercise
Multifidus
Abdominal transverse
Non-specific chronic low back pain
Transcutaneous electric nerve stimulation
Exercise therapy
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo controlled clinical trial.
Primary purpose: TREATMENT

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

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.
* Depression
* Judicial dispute

Primary outcomes:
measure: Increased cross-sectional area in activation
timeFrame: Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
measure: Changes in the measurements of the multifidus and tranverse of the abdomen at rest.
timeFrame: Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
Secondary outcomes:
measure: Intensity of Pain
timeFrame: (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
measure: Pressure pain threshold using an algometer
timeFrame: Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
measure: Temporal summation
timeFrame: Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
measure: Conditioned pain modulation
timeFrame: Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
measure: Pain Grade Questionnaire
timeFrame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
measure: Oswestry Disability Index or Oswestry Low Back Pain Disability Questionnaire
timeFrame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
measure: Short form 12 (SF-12) health survey (health-related quality of life)
timeFrame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
measure: Kinesiophobia
timeFrame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
measure: Pain catastrophizing
timeFrame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
measure: The Becks Depression Inventory-II
timeFrame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
measure: Anxiety
timeFrame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
measure: Global Rating of Change Scale
timeFrame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
measure: Blinding the patient
timeFrame: 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
measure: Central Sensitization Inventory
timeFrame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Josue Fernández-Carnero, PhD
role: PRINCIPAL_INVESTIGATOR
References: