Clinical trial NCT03738748: Effectiveness of Ecoguided Percutaneous Neuromodulation of the Multipurpose Musculature of L-3 in Non-specific Chronic Lumbar Pain.
Official title: Effectiveness of the Ecoguided Percutaneous Neuromodulation of the Multipurpose Musculature of L-3 in Non-specific Chronic Lumbar Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Neuromodulation
Low back pain
Ultrasound-guied percutaneous
TENS
Randomized Controlled Trial
Percutaneous stimulation
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
timeFrame: At baseline and at 4 weeks (immediate post-treatment)
Secondary outcomes:
measure: Change from baseline in disability. Oswestry Low Back Pain Disability Index (ODI).
timeFrame: At baseline and at 4 weeks (immediate post-treatment)
measure: Change from baseline in pain intensity (Visual Analogue Scale).
timeFrame: At baseline and at 4 weeks (immediate post-treatment)
measure: Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
timeFrame: At baseline and at 4 weeks (immediate post-treatment)
measure: Change from baseline on Quality of Life.
timeFrame: At baseline and at 4 weeks (immediate post-treatment)
measure: Change from Mcquade Test
timeFrame: At baseline and at 4 weeks (immediate post-treatment)
measure: Change from baseline in lumbar mobility flexion
timeFrame: At baseline and at 4 weeks (immediate post-treatment)
measure: Change from baseline in range of motion and lumbar segmental mobility
timeFrame: At baseline and at 4 weeks (immediate post-treatment)
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Adelaida María Castro-Sánchez
Study officials:
References:
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