An interventional study of Ultrasound- guided Percutaneous Neuromulation and TENS Therapy in Low Back Pain, sponsored by Universidad de Almeria. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Universidad de Almeria · Not applicable, Interventional, and Treatment
The study evaluates the effectiveness of Ultrasound-guided Percutaneous Neuromodulation in the lumbar multifidus of L3 in non-specific chronic low back pain.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Universidad de Almeria is the lead sponsor of 71 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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 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 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.
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.
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.
Time frame: At baseline and at 4 weeks (immediate post-treatment)
Change from baseline in disability. Oswestry Low Back Pain Disability Index (ODI).
It has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points.
Time frame: At baseline and at 4 weeks (immediate post-treatment)
Change from baseline in pain intensity (Visual Analogue Scale).
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.
Time frame: At baseline and at 4 weeks (immediate post-treatment)
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
It is a 17-item questionnaire that measures the fear of movement and (re)injury
Time frame: At baseline and at 4 weeks (immediate post-treatment)
Change from baseline on Quality of Life.
SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
Time frame: At baseline and at 4 weeks (immediate post-treatment)
Change from Mcquade Test
It measures the isometric endurance of trunk flexion muscles
Time frame: At baseline and at 4 weeks (immediate post-treatment)
Change from baseline in lumbar mobility flexion
It is determined by measuring the finger-to-floor distance
Time frame: At baseline and at 4 weeks (immediate post-treatment)
Change from baseline in range of motion and lumbar segmental mobility
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.
Time frame: At baseline and at 4 weeks (immediate post-treatment)
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Universidad de Almeria