NCT07373808 Efficacy of Sciatic Nerve Electrical Stimulation and Therapeutic Exercise in the Management of Low-back Related Leg Pain

Eligibility & Interventions

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This trial targets 88 participants in total. It began in 2026-05-13 with a primary completion date of 2027-01.

Brief Summary

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 program. PENS uses very thin sterile needles inserted under ultrasound guidance next to the nerve. A gentle electrical current is then applied for about 30 minutes to stimulate the nerve in a controlled way. This may help calm down nerve sensitivity, reduce inflammation, and decrease pain. We will compare PENS with three other options: Transcutaneous Electrical Nerve Stimulation (TENS): A commonly used therapy where mild electrical stimulation is applied through adhesive patches placed on the skin; Dry needling without electrical current: Thin needles are inserted under ultrasound guidance but no current is applied; and placebo treatment: A simulated version of the therapy with no active current, designed to look and feel similar so that participants do not know which treatment they are receiving. In addition to these treatments, all participants will take part in a structured exercise program aimed at strengthening the lower back, pelvis, and legs. Exercises like curl-ups, planks, bridges, bird-dogs, and squats will be supervised weekly for six weeks, with guidance to continue practicing at home. Exercise is included because it is known to help improve mobility, strength, and recovery in people with back problems. The study is designed as a randomized, controlled, double-blind trial, which means that participants are assigned to one of the four groups by chance (like flipping a coin), and neither the patients nor the therapists who collect the measurements will know which treatment has been given. This design ensures fairness and reliability of the results. We will measure: Back and leg pain levels, using a simple 0-10 scale; Disability, meaning how much the pain limits daily activities, measured with a well-known questionnaire; Quality of life, both physical and mental health aspects; Nerve-related pain features, like burning or electric-like sensations; and patients' global impression of improvement and any side effects. Assessments will take place before starting the treatment, at the end of the 6-week program, and then again at 3 and 6 months. This allows us to see both the short-, mid- and long-term effects. Safety considerations: Previous research shows that PENS and similar techniques are generally very safe. The most common side effects are mild and short-lasting, including temporary soreness, heaviness in the leg, or a small bruise. Serious complications are extremely rare. To minimize risks, all procedures will be carried out by experienced physiotherapists, using real-time ultrasound to guide needle placement and ensure accuracy. Only sterile, single-use needles are employed. By comparing PENS, TENS, dry needling, and placebo, this study seeks to determine whether PENS in combination with therapeutic exercise provides superior benefits in reducing pain, improving function, and enhancing quality of life for patients with sciatica-type low back pain. If successful, this treatment could become a valuable alternative to drugs or surgery, offering patients a safe and effective therapy to better manage their condition and regain daily function.

Eligibility 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.

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