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Completed

NCT Number: NCT03738748

Effectiveness of Ecoguided Percutaneous Neuromodulation of the Multipurpose Musculature of L-3 in Non-specific Chronic Lumbar Pain.

The study evaluates the effectiveness of Ultrasound-guided Percutaneous Neuromodulation in the lumbar multifidus of L3 in non-specific chronic low back pain.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adelaida María Castro-Sánchez

Almería, 04120, Spain

About this study

The effectiveness of neuromoduation in analgesic therapies has been more than contrasted. Considering that multifidus muscles, composed of the spinous transverse rotators muscles and spinous transverse multifidus muscles, are fundamental both for the static and for the dynamics of the lumbar spine, particularly for the region of L-3, the treatment of this musculature with ultrasound-guided percutaneous neuromodulation in patients with nonspecific chronic low back pain must have an analgesic repercussion in this nociceptive process.

Therefore, given that neuromodulation has been considered as a more than effective treatment in painful symptomatology and that diverse scientific literature has proven the activity of the multifida musculature directly affects the stability and mobility of the lumbar spine, it is more than likely interventions with neuromodulative treatments in the multifidus musculature at the level of the third lumbar vertebrae have positive results in Non-specific Chronic Low Back Pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Score ≥4 on the Roland Morris Disability Questionnaire.
  • Low back pain for ≥3 months
  • Age between 18 and 65 years
  • Not undergoing another physical therapy treatment

Exclusion criteria

  • Presence of lumbar stenosis
  • Diagnosis of spondylolisthesis
  • Diagnosis of fibromyalgia
  • Treatment with corticosteroid or oral medication within the past two weeks
  • A history of spinal surgery
  • Contraindication of analgesic electrical therapy
  • Having previously received a treatment of electrical analgesia.

Treatment and study plan

Ultrasound- guided Percutaneous Neuromulation

Other

The experimental group will be treated with percutaneous neuromodulation using a needle with Physio Invasive® device, in its modality of percutaneous electrostimulation for 15 minutes, and guided by ultrasound equipment in the multifidus muscles of L-3, once a week for 4 weeks.

TENS Therapy

Other

The control group will apply a transcutaneous treatment with surface electrodes with TENS current at 170 Hz for 15 minutes in the L-3 region, once a week for 4 weeks.

Primary outcomes

  1. Change from baseline in Roland Morris Disability Questionnaire (RMDQ)

    Time frame: At baseline and at 4 weeks (immediate post-treatment)

    This is a self-reported questionnaire consisting in 24 ítems reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.

Secondary outcomes

  1. Change from baseline in disability. Oswestry Low Back Pain Disability Index (ODI).

    Time frame: At baseline and at 4 weeks (immediate post-treatment)

    It has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points.

  2. Change from baseline in pain intensity (Visual Analogue Scale).

    Time frame: At baseline and at 4 weeks (immediate post-treatment)

    A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.

  3. Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.

    Time frame: At baseline and at 4 weeks (immediate post-treatment)

    It is a 17-item questionnaire that measures the fear of movement and (re)injury

  4. Change from baseline on Quality of Life.

    Time frame: At baseline and at 4 weeks (immediate post-treatment)

    SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.

  5. Change from Mcquade Test

    Time frame: At baseline and at 4 weeks (immediate post-treatment)

    It measures the isometric endurance of trunk flexion muscles

  6. Change from baseline in lumbar mobility flexion

    Time frame: At baseline and at 4 weeks (immediate post-treatment)

    It is determined by measuring the finger-to-floor distance

  7. Change from baseline in range of motion and lumbar segmental mobility

    Time frame: At baseline and at 4 weeks (immediate post-treatment)

    This variable is quantified using the SpinalMouse® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagital spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

Effectiveness of the Ecoguided Percutaneous Neuromodulation of the Multipurpose Musculature of L-3 in Non-specific Chronic Lumbar Pain.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2018
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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