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

NCT03738748 | Completed

• 1 other identifier: HLA-12
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain

Keywords

Neuromodulation; Low back pain; Ultrasound-guied percutaneous; TENS; Randomized Controlled Trial; Percutaneous stimulation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Roland Morris Disability Questionnaire (RMDQ)

  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 Outcomes (7)

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

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

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

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

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

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

• Change from baseline on Quality of Life.

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

• Change from Mcquade Test

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

Study Arms (2)

Ultrasound-guided Percutaneous Neuromodulation

EXPERIMENTAL

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

TENS therapy

ACTIVE COMPARATOR

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

Interventions

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.

Ultrasound-guided Percutaneous Neuromodulation

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.

TENS therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Adelaida María Castro-Sánchez

Almería, 04120, Spain

Location

Related Publications (14)

• Goubert D, De Pauw R, Meeus M, Willems T, Cagnie B, Schouppe S, Van Oosterwijck J, Dhondt E, Danneels L. Lumbar muscle structure and function in chronic versus recurrent low back pain: a cross-sectional study. Spine J. 2017 Sep;17(9):1285-1296. doi: 10.1016/j.spinee.2017.04.025. Epub 2017 Apr 26.

  PMID: 28456669 BACKGROUND

• Freeman MD, Woodham MA, Woodham AW. The role of the lumbar multifidus in chronic low back pain: a review. PM R. 2010 Feb;2(2):142-6; quiz 1 p following 167. doi: 10.1016/j.pmrj.2009.11.006.

  PMID: 20193941 BACKGROUND

• Rajfur J, Pasternok M, Rajfur K, Walewicz K, Fras B, Bolach B, Dymarek R, Rosinczuk J, Halski T, Taradaj J. Efficacy of Selected Electrical Therapies on Chronic Low Back Pain: A Comparative Clinical Pilot Study. Med Sci Monit. 2017 Jan 7;23:85-100. doi: 10.12659/msm.899461.

  PMID: 28062862 BACKGROUND

• Bredow J, Bloess K, Oppermann J, Boese CK, Lohrer L, Eysel P. [Conservative treatment of nonspecific, chronic low back pain : Evidence of the efficacy - a systematic literature review]. Orthopade. 2016 Jul;45(7):573-8. doi: 10.1007/s00132-016-3248-7. German.

  PMID: 27075679 BACKGROUND

• Wallwork TL, Stanton WR, Freke M, Hides JA. The effect of chronic low back pain on size and contraction of the lumbar multifidus muscle. Man Ther. 2009 Oct;14(5):496-500. doi: 10.1016/j.math.2008.09.006. Epub 2008 Nov 21.

  PMID: 19027343 BACKGROUND

• Hides JA, Stanton WR, McMahon S, Sims K, Richardson CA. Effect of stabilization training on multifidus muscle cross-sectional area among young elite cricketers with low back pain. J Orthop Sports Phys Ther. 2008 Mar;38(3):101-8. doi: 10.2519/jospt.2008.2658. Epub 2007 Dec 7.

  PMID: 18349481 BACKGROUND

• Kirby CC. A look at radiologic technology education. Radiol Technol. 1975 Sep-Oct;47(2):82-9.

  PMID: 1188084 BACKGROUND

• Ramirez-Garcia I, Blanco-Ratto L, Kauffmann S, Carralero-Martinez A, Sanchez E. Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: Randomized control trial. Neurourol Urodyn. 2019 Jan;38(1):261-268. doi: 10.1002/nau.23843. Epub 2018 Oct 12.

  PMID: 30311692 BACKGROUND

• Nayak R, Banik RK. Current Innovations in Peripheral Nerve Stimulation. Pain Res Treat. 2018 Sep 13;2018:9091216. doi: 10.1155/2018/9091216. eCollection 2018.

  PMID: 30302288 BACKGROUND

• Ilfeld BM, Gabriel RA, Said ET, Monahan AM, Sztain JF, Abramson WB, Khatibi B, Finneran JJ 4th, Jaeger PT, Schwartz AK, Ahmed SS. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Sciatic Nerve for Postoperative Analgesia Following Ambulatory Foot Surgery, a Proof-of-Concept Study. Reg Anesth Pain Med. 2018 Aug;43(6):580-589. doi: 10.1097/AAP.0000000000000819.

  PMID: 29905630 BACKGROUND

• Ilfeld BM, Said ET, Finneran JJ 4th, Sztain JF, Abramson WB, Gabriel RA, Khatibi B, Swisher MW, Jaeger P, Covey DC, Robertson CM. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Femoral Nerve for Postoperative Analgesia Following Ambulatory Anterior Cruciate Ligament Reconstruction: A Proof of Concept Study. Neuromodulation. 2019 Jul;22(5):621-629. doi: 10.1111/ner.12851. Epub 2018 Aug 30.

  PMID: 30160335 BACKGROUND

• Facci LM, Nowotny JP, Tormem F, Trevisani VF. Effects of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) in patients with nonspecific chronic low back pain: randomized clinical trial. Sao Paulo Med J. 2011;129(4):206-16. doi: 10.1590/s1516-31802011000400003.

  PMID: 21971895 BACKGROUND

• Valera-Garrido F, Minaya-Munoz F, Medina-Mirapeix F. Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results. Acupunct Med. 2014 Dec;32(6):446-54. doi: 10.1136/acupmed-2014-010619. Epub 2014 Aug 13.

  PMID: 25122629 BACKGROUND

• Gofeld M. Ultrasound-guided caudad epidural access for the lumbosacral neurostimulation: case report and technical note. Neuromodulation. 2011 Jan;14(1):68-71; discussion 71. doi: 10.1111/j.1525-1403.2010.00297.x. Epub 2010 Oct 7.

  PMID: 21992165 BACKGROUND

Related Links

• Neuromodulación eléctrica y dolor raquídeo.
• Spinal cord stimulation versus conventional medical management for neuropathic pain: A multicentre randomised controlled trial in patients with failed back surgery syndrome.
• Prospective, Two-part Study of the Interaction Between Spinal Cord Stimulation and Peripheral Nerve Field Stimulation in Patients with Low Back Pain: Development of a New Spinal-Peripheral Neurostimulation Method

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 20, 2018
• First Posted: November 13, 2018
• Study Start: September 20, 2024
• Primary Completion: January 31, 2025
• Study Completion: May 20, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

ES (1)