Percutaneous Neuromuscular Electrical Stimulation in Patients With Chronic Low Back Pain

Browse trials for

• Back Pain 2,373
• Low Back Pain 2,818

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

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 64 is close to the median of 60 across 1,941 interventional studies indexed under Back Pain.

Lead sponsor

Universidad Rey Juan Carlos is the lead sponsor of 111 studies on the registry; 22 are open to participants now.

Study arms

• 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) plus motor control exercise program

• 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

• 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

• 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: Sham PNMES (without inserting the needle) plus motor control exercise program

Interventions

• OtherPercutaneous neuromuscular electrical stimulation (PNMES) plus motor control exercise program

  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.

  Also known as: Percutaneous electric nerve stimulation (PENS)

• OtherSham 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.

  Also known as: Sham PENS

• OtherTENS 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.

  Also known as: TENS

• OtherSham 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.

  Also known as: Sham PENS

Primary outcomes

1. Increased cross-sectional area in activation

   The increase in height from the resting position to the submaximal contraction in the lumbar multifidus will be measured

   Time frame: Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

2. Changes in the measurements of the multifidus and tranverse of the abdomen at rest.

   Changes in the height of the multifidus 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

Secondary outcomes

1. Intensity of Pain

   Will be measure with a line of 100 mmm (0 - no pain to 100- the worst pain) at rest and his best and worst pain in the last 24 hours.

   Time frame: (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

2. Pressure pain threshold using an algometer

   Measurement of pressure pain threshold in the paravertebral muscles, in the spinous process of L4, and the tibialis anterior muscle.

   Time frame: Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

3. Temporal summation

   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

   Time frame: Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

4. Conditioned pain modulation

   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.

   Time frame: Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

5. Pain Grade Questionnaire

   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.

   Time frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

6. Oswestry Disability Index or Oswestry Low Back Pain Disability Questionnaire

   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.

   Time frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

7. Short form 12 (SF-12) health survey (health-related quality of life)

   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.

   Time frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

8. Kinesiophobia

   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

   Time frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

9. Pain catastrophizing

   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.

   Time frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

10. The Becks Depression Inventory-II

    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).

    Time frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

11. Anxiety

    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).

    Time frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

12. Global Rating of Change Scale

    Global Rating of Change (GRoC) 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).

    Time frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

13. Blinding the patient

    The patients of the sham groups will be asked after the interventions of PNMES if they belonged to the group of deep electro-stimulation, being able to content: Sure that yes, moderately that yes, I do not know, moderately that no or sure that no.

    Time frame: 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

14. Central Sensitization Inventory

    The Spanish version of the Central Sensitisation Inventory will be used to identify symptoms related to central sensitisation. It is a self-report questionnaire that assesses a total of 25 sensitisation-associated symptoms on a 5-point Likert scale. The total score ranges from 0 to 100, where \>40/100 points suggest the presence of sensitisation-associated symptoms. It has been found to have high reliability and validity.

    Time frame: Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

Related links

• Hospital PRincipe de Asturias ↗

Individual participant data

Plan to share: No