Single-session electrical nerve stimulation for sciatic-related leg pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests the immediate and short-term effects of a single PENS session targeted near the sciatic nerve for people with chronic sciatica-related leg pain. Participants are randomized to active PENS, sham transcutaneous stimulation, real dry needling without PENS, or sham PENS, to assess short-term pain relief and safety. The procedure uses thin needles placed under ultrasound guidance near the nerve, with non-drug, non-surgical aims in mind. Outcomes focus on pain intensity and functional impact in the days following treatment. The trial is conducted at Hospital Universitario 12 de Octubre in Madrid, led by Universidad Complutense de Madrid in collaboration with local physiotherapist groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario 12 de Octubre
  Madrid, Madrid, Spain Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.