Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Percutaneous Neuromuscular Electrical Stimulation in Patients With Chronic Low Back Pain (PNMESlowback)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243915
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Josue Fernandez Carnero, Universidad Rey Juan Carlos

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


Condition or disease Intervention/treatment Phase
Low Back Pain Other: Percutaneous neuromuscular electrical stimulation (PNMES) Other: Sham PNMES (introducing the needle) plus motor control exercise program Other: TENS plus motor control exercise program Other: Placebo PNMES (without inserting the needle) plus motor control exercise program Not Applicable

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).

Conditions:Non-specific chronic low back Pain

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo controlled clinical trial.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 12, 2020
Estimated Primary Completion Date : February 10, 2021
Estimated Study Completion Date : April 14, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PNMES plus exercise
6-week intervention program with 3 treatment sessions of PNMES and motor control exercise program.
Other: Percutaneous neuromuscular electrical stimulation (PNMES)
The technique consists of a muscular stimulation of the deep lumbar multifidus by means of a TENS current applied through four dry needling or acupuncture needles introduced by ultrasound guidance in said muscle 30 minutes. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
Other Name: Percutaneous electric nerve stimulation (PENS)

Sham Comparator: Sham PNMES (introducing the needle) plus exercise
Sham PNMES (introducing the needle) plus motor control exercise program
Other: Sham PNMES (introducing the needle) plus motor control exercise program
The same procedure will be performed as in the experimental treatment, but in this case, the electric current will be placebo and only the first 15 seconds will slightly notice it. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
Other Name: Sham PENS

Active Comparator: TENS plus exercise
6-week intervention program with 3 treatment sessions of TENS plus motor control exercise program.
Other: TENS plus motor control exercise program
Transcutaneous electrical nerve stimulation will be applied through 4 patches / adhesives placed in your lower back for 30 minutes. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
Other Name: TENS

Placebo Comparator: Placebo PNMES (without inserting the needle) plus exercise
6-week intervention program with 3 treatment sessions of placebo PNMES (without inserting the needle) and exercise
Other: Placebo PNMES (without inserting the needle) plus motor control exercise program
The same procedure will be performed as in the experimental treatment, but in this case, the needle will not be inserted and the electric current will be placebo and only the first 15 seconds will slightly notice it. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
Other Name: Placebo PENS




Primary Outcome Measures :
  1. Increased cross-sectional area in activation [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    The increase in the cross-sectional area from the resting position to the submaximal contraction in the lumbar multifidus and in the transverse abdomen will be measured

  2. Multifidus lift test [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    The participants will realize the action of the test, the therapist determine if the activation is normal or non-normal using the palpation.

  3. Prone instability test. [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    Test for the likelihood of a patient responding positively to a spinal stabilization program. A positive test is considered if the patient has pain with pressure in the resting position, and the pain decreases in the active position.


Secondary Outcome Measures :
  1. Intensity of Pain [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    Will be measure with a line of 100 mmm (0 - no pain to 100- the worst pain).

  2. Pressure pain threshold using an algometer [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    Measurement of pressure pain threshold in the paravertebral muscles at L3, L4 and L5 levels, sciatic nerve and the tibialis anterior muscle.

  3. Area of pain [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    The participants will paint the area of extension of their pain in a body chart. The area in mm^2 will be calculated using a software.

  4. Pain distribution [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    The pain distribution will be classified as 0=no pain, 1=pain only proximal to low back pain, 2=proximal pain in the buttocks and leg, 3= pain in other regions (calf and foot) using the painted region in the body chart.

  5. Temporal summation [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    Ten consecutives pressure pain stimulus will be conducted, pain intensity in the first, fifth and tenth will be asked. The difference from 1 to 10 will be the value that reports on the state of excitability of the posterior horn of the medulla

  6. Conditioned pain modulation [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    First, pressure pain stimulus (test stimulus) will be conducted in the distal phalanx of the thumb. Second, occlusion cuff will be inflated around the arm of patient until the patient feeling a painful intensity (conditioned stimulus) of 6/10. Finally, after 30 seconds the stimulus will be done. The difference in the mean value of the initial algometry with the mean value of algometry during the conditioning stimulus will indicate the state of the descending pain inhibitory system.

  7. Pain Grade Questionnaire [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    The scale assesses two dimensions: the intensity of pain and pain related to disability. It can be used in any chronic pathology including musculoskeletal problems and low back pain. It allows the graduation of the severity of chronic pain and the subsequent analysis of the qualitative changes for that pain. The scale has 7 items, which are of the Likert type of 11 points, with a total range of 0 to 70 points.

  8. Oswestry Disability Index or Oswestry Low Back Pain Disability Questionnaire [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]

    The Oswestry Disability Index (ODI) is a validated, self-reported instrument used by clinicians and researchers to quantify disability for low back pain.

    The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.


  9. Short form 12 (SF-12) health survey (health-related quality of life) [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    The SF-12 is a validated, health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). The instrument has been validated across a number of chronic diseases and conditions. The response options of the SF-12 v2 form Likert-type scales that evaluate intensity or frequency. The number of answer options ranges from three to six, depending on the item, and each question is given a value which is then transformed into a scale from 0 to 100.

  10. Lumbar Strength [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    Measurement the amount of force that the patient generates to the onset of pain as measured with a dynamometer.

  11. Kinesiophobia [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    Tampa Scale for Kinesiophobia. To assess the fear of movement and pain-related fear. The 11 items are scored 1-4, with total scores ranging from 11 to 44. The addition of all the points obtained from each of the items results in the level of kinesiophobia, with higher scores indicating greater perceived kinesiophobia

  12. Pain catastrophizing [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    Pain Catastrophizing Scale (PCS). This tool is a 13-item questionnaire designed to measure the three components of pain-related catastrophizing: rumination, magnification, and helplessness, resulting in a unique score. Each item is responded to on a 5-point scale (0 not at all, 4 all the time) relating the degree to which the individual experiences a thought or feeling of a painful situation.

  13. The Becks Depression Inventory-II [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    The Becks Depression Inventory-II is a validated, self-administered questionnaire consisting of 21 multiple choice questions. It is one of the most commonly used instruments to measure the severity of a depression. Possible scores range from 0 (no depression) to 63 (severe depression).

  14. Anxiety [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    The state-trait anxiety inventory (STAI) is a questionnaire that measures trait anxiety (a personality factor that predisposes the patient to suffer from anxiety) and the state of anxiety (environmental factors that protect or generate anxiety). Each of the two sub-scales (trait anxiety and state anxiety) consists of 20 items, ranging from 0 (nothing) to 3 (a lot).

  15. Global Rating of Change Scale [ Time Frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline ]
    Global Rating of Change (GRC) scales provide a means of measuring self-perceived change in health status. Possible scores range from -5 (very much worse), through 0 (unchanged) to +5 (completely recovered).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed patients of nonspecific chronic low back pain in the Hospital or in health centers.
  • Low back pain more than 90 days of evolution
  • A score in Oswestry Disability Index more than 20%.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243915


Contacts
Layout table for location contacts
Contact: Alberto Arribas-Roamno, MsC 635937520 albertoarribasromano@gmail.com

Locations
Layout table for location information
Spain
Universidad Rey Juan Carlos
Alcorcon, Madrid, Spain, 28922
Sponsors and Collaborators
Universidad Rey Juan Carlos
Investigators
Layout table for investigator information
Principal Investigator: Josue Fernández-Carnero, PhD Rey Juan Carlos University
Additional Information:
Layout table for additonal information
Responsible Party: Josue Fernandez Carnero, PhD, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT04243915    
Other Study ID Numbers: EC 01/2019
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Josue Fernandez Carnero, Universidad Rey Juan Carlos:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms