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

May 28, 2025 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

Effectiveness of the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04120
        • Adelaida María Castro-Sánchez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound-guided Percutaneous Neuromodulation
This 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 L3 (1 times/ 4 weeks).
Other: Ultrasound- guided Percutaneous Neuromulation
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.
Active Comparator: TENS therapy
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 (1 times/ 4 weeks).
Other: TENS Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and at 4 weeks (immediate post-treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and at 4 weeks (immediate post-treatment)
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.
At baseline and at 4 weeks (immediate post-treatment)
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
At baseline and at 4 weeks (immediate post-treatment)
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.
At baseline and at 4 weeks (immediate post-treatment)
Change from Mcquade Test
Time Frame: At baseline and at 4 weeks (immediate post-treatment)
It measures the isometric endurance of trunk flexion muscles
At baseline and at 4 weeks (immediate post-treatment)
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
At baseline and at 4 weeks (immediate post-treatment)
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.
At baseline and at 4 weeks (immediate post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

May 20, 2025

Study Registration Dates

First Submitted

October 20, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (Actual)

November 13, 2018

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLA-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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