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

Not Applicable

Recruiting

• Conditions: Low Back Pain
• Interventions: Other: Ultrasound- guided Percutaneous Neuromulation; Other: TENS Therapy

• Registration Number: NCT03738748
• Lead Sponsor: Universidad de Almeria

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.

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 Timeline

• Study First Submitted: 2018-10-20
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-13
• Status Verified: 2023-09
• Study Start: 2023-09-20
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-03-31
• Study Completion: 2024-07-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided Percutaneous Neuromodulation	Ultrasound- guided Percutaneous Neuromulation	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).
TENS therapy	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).

Primary Outcome Measures

Name	Time	Method
Change from baseline in Roland Morris Disability Questionnaire (RMDQ)	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 Outcome Measures

Name	Time	Method
Change from Mcquade Test	At baseline and at 4 weeks (immediate post-treatment)	It measures the isometric endurance of trunk flexion muscles
Change from baseline in lumbar mobility flexion	At baseline and at 4 weeks (immediate post-treatment)	It is determined by measuring the finger-to-floor distance
Change from baseline in pain intensity (Visual Analogue Scale).	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.
Change from baseline on Quality of Life.	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.
Change from baseline in disability. Oswestry Low Back Pain Disability Index (ODI).	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.
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.	At baseline and at 4 weeks (immediate post-treatment)	It is a 17-item questionnaire that measures the fear of movement and (re)injury
Change from baseline in range of motion and lumbar segmental mobility	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.

Trial Locations

Locations (1)

Adelaida María Castro-Sánchez; 🇪🇸 Almería, Spain