Actively Recruiting
Efficacy of Sciatic Nerve Electrical Stimulation and Therapeutic Exercise in the Management of Low-back Related Leg Pain
Led by Universidad Complutense de Madrid · Updated on 2026-05-14
88
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
U
Universidad Complutense de Madrid
Lead Sponsor
C
Colegio de Fisioterapeutas de la Comunidad de Madrid
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of Percutaneous Electrical Nerve Stimulation (PENS) combined with therapeutic exercise for people suffering from long-term low-back related leg pain, often called sciatica. Sciatica is caused by nerve irritation or compression in the lower spine, leading to symptoms like shooting or burning pain, numbness, tingling, or weakness in the leg. Many people continue to experience this pain for months or years, and current treatments such as medications or surgery may not provide lasting relief, prompting the need for new, non-drug, non-surgical options. Participants in this randomized, controlled, double-blind study will be assigned to one of four groups: PENS with placebo Transcutaneous Electrical Nerve Stimulation (TENS), real TENS with placebo PENS, real dry needling without electrical stimulation combined with placebo TENS, or placebo versions of both PENS and TENS. PENS involves thin needles inserted near the sciatic nerve guided by ultrasound, with gentle electrical stimulation applied for 30 minutes. The other groups receive either real or sham versions of electrical or needle treatments. All participants will also engage in a structured exercise program focused on strengthening the lower back, pelvis, and legs, including exercises like curl-ups, planks, bridges, bird-dogs, and squats, supervised weekly for six weeks with guidance for home practice. During the study, participants will be assessed before treatment, at the end of the 6-week program, and again at 3 and 6 months. Researchers will measure pain levels, disability affecting daily activities, quality of life, nerve-related pain features, global improvement, and any side effects. Safety will be closely monitored, with experienced therapists using sterile needles and ultrasound guidance to reduce risks. This study seeks to determine if PENS combined with exercise offers better relief and improved function compared to other treatments for sciatica-related leg pain.
CONDITIONS
Brief Title
Efficacy of Sciatic Nerve Electrical Stimulation and Therapeutic Exercise in the Management of Low-back Related Leg Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neuropathic-like low-back related leg pain (sciatica).
- S-LANSS score of 12 points or higher.
- Low-back related leg pain lasting more than 6 months.
- Age between 18 and 70 years.
- Recent leg pain limiting usual activities for more than 1 day in the past 4 weeks.
- At least one period of 6 months to 1 year with persistent pain.
- Pain intensity of at least 3 out of 10 on the Numeric Pain Rating Scale.
- Ability to provide informed consent.
You will not qualify if you...
- Recent acute injury or major trauma.
- Painful conditions of the hip joint or pelvic/sacroiliac region.
- Symptoms of cauda equina syndrome such as loss of bladder/bowel control or paralysis.
- Previous surgery on spine, pelvis, or hip.
- Treatment with anesthetic or anti-inflammatory blocks or radiofrequency in the past 2 years.
- Neurological or systemic diseases limiting study participation.
- Inability to communicate in Spanish or understand study instructions.
- General contraindications for invasive physiotherapy and electrotherapy techniques.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Multiple weeks with weekly sessions
Participants receive one of several interventions involving electrical nerve stimulation or dry needling combined with a progressive therapeutic exercise program, designed to manage low-back related leg pain. Interventions last 30 minutes per session with weekly supervised exercise sessions plus home exercises.
Weekly supervised sessions plus home exercises at least twice a week
Duration - Up to 6 months post-intervention
Participants are monitored for pain intensity, disability, quality of life, neuropathic pain, and global improvement after treatment completion.
3 follow-up visits (1 week, 3 months, and 6 months post-intervention)
Trial Site Locations
Total: 1 location
1
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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