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

NCT ID: NCT03738748

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-20

Study Completion Date

2025-05-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Ultrasound- guided Percutaneous Neuromulation

Intervention Type 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

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).

Group Type ACTIVE_COMPARATOR

TENS Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Almeria

OTHER

Sponsor Role lead

Responsible Party

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Adelaida María Castro-Sánchez

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Adelaida María Castro-Sánchez

Almería, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 28456669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20193941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28062862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27075679 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19027343 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18349481 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 1188084 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30311692 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30302288 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29905630 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30160335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21971895 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25122629 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21992165 (View on PubMed)

Related Links

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http://dx.doi.org/10.4321/S1134-80462015000300006

Neuromodulación eléctrica y dolor raquídeo.

https://doi.org/10.1016/j.pain.2007.07.028

Spinal cord stimulation versus conventional medical management for neuropathic pain: A multicentre randomised controlled trial in patients with failed back surgery syndrome.

https://doi.org/10.1111/j.1525-1403.2010.00316.x

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

Other Identifiers

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HLA-12

Identifier Type: -

Identifier Source: org_study_id

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