PENS near the sciatic nerve plus therapeutic exercise for leg pain from sciatica
Official title: Efficacy of Sciatic Nerve Electrical Stimulation and Therapeutic Exercise in the Management of Low-back Related Leg Pain
Run by Universidad Complutense de Madrid · NCT07373808 · Data updated 2026-11-12
This study tests whether a nearby nerve stimulation procedure combined with a structured exercise program can help people with long-lasting sciatica pain.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | Universidad Complutense de Madrid Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Status | Recruiting |
| Started | May 13, 2026 |
| Main results expected | January 2027 |
| Study ends | December 2027 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT07373808 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–70 with chronic sciatica-related leg pain lasting more than 6 months and neuropathic-like features (S-LANSS ≥ 12).
✕Probably not a fit
Patients with recent spine trauma, hip joint issues, cauda equina symptoms, prior spine/pelvic/hip surgery, or recent extensive nerve/interventional treatments may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial investigates Percutaneous Electrical Nerve Stimulation (PENS) applied near the sciatic nerve together with a therapeutic exercise regimen for adults with chronic sciatica-related leg pain. It compares active PENS and sham/placebo options with other electrical stimulation methods to assess safety and effectiveness. Participants have neuropathic-like leg pain persisting over six months and meet specific symptom criteria, including S-LANSS and NPRS thresholds. The study uses ultrasound guidance for needle placement and includes randomized or controlled elements to evaluate outcomes over a defined period. Outcomes likely focus on pain relief, functional ability, and safety.
Why it matters
Potential benefit: If successful, participants may experience reduced leg pain and improved function without relying solely on medications or surgery.
How similar studies have gone: Evidence from similar neuromodulation approaches suggests potential for pain relief, though this exact near-nerve stimulation method with PENS and exercise is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Steroid Injections for Back and Neck Pain: What Works Best
This study tests different steroid injections and combinations to see what provides the best pain relief and function for adults with back or neck pain.
-
Somatosensory motor training with or without Kinesio tape for sciatica
This trial tests whether adding Kinesio tape to somatosensory motor control training helps people with discogenic sciatica reduce pain and improve movement and balance.
-
Three CT Signs of Nerve-Root Suffering in Low-Back Sciatica: How Often They Occur in Patients Referred for CT-Guided Nerve-Root Infiltration
This study tests whether three specific CT signs align with the nerve root causing symptoms in adults with low-back sciatica who are scheduled for CT-guided nerve-root infiltration.
-
Comparing tensioner vs slider neurodynamic techniques for sciatic nerve pain
This trial tests whether tensioner or slider neurodynamic therapy is better at reducing pain and improving function for people with sciatica.
-
Finnish comparison of microdiscectomy versus sham surgery for lumbar disc herniation
This trial tests whether microdiscectomy provides better pain relief and recovery than a sham operation for adults with sciatica from a lumbar disc herniation who haven't improved after at least six weeks of non-surgical care.
-
Single-session electrical nerve stimulation for sciatic-related leg pain
A one-time Percutaneous Electrical Nerve Stimulation (PENS) treatment near the sciatic nerve is tested to see if it helps long-standing leg pain from low back issues.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.