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Efficacy of Sciatic Nerve Electrical Stimulation and Therapeutic Exercise in the Management of Low-back Related Leg Pain

RecruitingNAAges 18 Years - 70 YearsAllUniversidad Complutense de Madrid
NCT07373808 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This clinical study focuses on people who experience long-term low-back related leg pain (commonly called sciatica). This type of pain is often associated with nerve irritation or compression in the lower spine and can cause symptoms like shooting or burning pain, tingling, numbness, or weakness in the leg. Many patients continue to suffer from this problem for months or years, and available treatments (including painkillers, anti-inflammatory drugs, or even surgery) do not always provide lasting relief. Because of this, there is a strong need to explore safe, non-drug, non-surgical therapies. The purpose of this study is to test the efficacy and safety of a treatment called Percutaneous Electrical Nerve Stimulation (PENS) when applied near the sciatic nerve, the large nerve that runs from the lower back through the buttock and down the leg, in combination with a therapeutic exercise pro

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📋 Eligibility rules (as published)
Inclusion Criteria: * Neuropathic-like LBRLP (sciatica). * S-LANSS score ≥ 12 points. * LBRLP lasting more than 6 months. * Age between 18 and 70 years. * LBRLP in the past 4 weeks has been severe enough to limit usual activities or change daily routines for more than 1 day. * At least one period of 6 months to 1 year during which the participant did not go a full month without LBRLP. * LBRLP intensity of at least 3/10 on the NPRS. * Ability to provide informed consent. Exclusion Criteria: * Acute injury or recent major trauma history. * Relevant painful conditions of the hip joint or pelvic/sacroiliac region. * Symptoms compatible with cauda equina syndrome (loss of bladder/bowel control, sexual dysfunction, paralysis of lower limbs, etc.). * Previous surgery on the spine, pelvis or hip. * Prior treatment with anesthetic or anti-inflammatory blocks or with radiofrequency (facet, sacroiliac, radicular, epidural, etc.) in the past two years. * Any neurological or systemic disease that could limit participation in the study. * Inability to communicate in Spanish or understand study instructions and content. * General contraindications for invasive physiotherapy and electrotherapy techniques.
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What it tests

  • Percutaneous Electrical Nerve Stimulation
  • Placebo Transcutaneous Electrical Nerve Stimulation
  • Transcutaneous Electrical Nerve Stimulation
  • Placebo Percutaneous Electrical Nerve Stimulation
  • Real Dry Needling (without Percutaneous Electrical Nerve Stimulation)
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Where

1 site
Hospital Universitario 12 de Octubre
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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