Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain

Study Overview
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Brief Summary
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In our daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation. In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. The objective of this study is to analyze that the effect of PNM on the sciatic nerve produces statistically significant changes in pain, joint range and functionality in patients with chronic LBP. Thirty subjects will be recruited, which will be divided into 3 groups: group 1 to which PNM will be applied to the sciatic nerve in the gluteus region; group 2 to which PNM will be applied to the sciatic nerve in the middle of the thigh; and group 3 to which PNM will be applied to the sciatic nerve before popliteus region. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current (250 microseconds, 3 Hz) during 90 seconds

Official Title
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Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain: a Pilot Study

Conditions
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Lower Back Pain

Intervention / Treatment
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* Other: NMP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Lower Back Pain Having no other therapy Exclusion Criteria: Other pathology (discal hernia, injured limbs, neurological pathology) Belenophobia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NMP in level 1<br>Participants in this group received NMP of the sciatic nerve in the gluteus region | Other: NMP<br>* Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 3 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.<br>|
| Experimental: NMP in level 2<br>Participants in this group received NMP of the sciatic nerve in the middle of the thigh | Other: NMP<br>* Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 3 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.<br>|
| Experimental: NMP in level 3<br>Participants in this group received NMP of the sciatic nerve before popliteus region | Other: NMP<br>* Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 3 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of pain | Measured by Visual Analogue Scale (0, no pain; 100, max pain) | From baseline measurement up to 1 week | 
| Range of motion | Measured by goniometer. Hip flexion, external and internal rotation range of motion | From baseline measurement up to 1 week | 
| Y Balance Test | Stability body | From baseline measurement up to 1 week | 
| Owestry questionnaire | Lower back pain questionnaire | From baseline measurement up to 1 week |