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Immediate and 1-week Efficacy of a Single Session of Sciatic Nerve Electrical Stimulation 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 immediate and short-term effects of a treatment called Percutaneous Electrical Nerve Stimulation (PENS) for people with long-term low-back related leg pain, commonly known as sciatica. This condition involves nerve irritation or compression in the lower spine, causing symptoms like shooting, burning pain, tingling, numbness, or leg weakness. Since existing treatments such as painkillers, anti-inflammatory drugs, or surgery do not always provide lasting relief, the study explores safe, non-drug, and non-surgical options to manage this pain. Participants will be randomly assigned to one of four groups: PENS involving thin needles inserted near the sciatic nerve with electrical stimulation; Transcutaneous Electrical Nerve Stimulation (TENS) using adhesive skin electrodes delivering mild electrical pulses; dry needling without electrical current involving needle insertion without stimulation; or a placebo group receiving simulated treatments without active electrical current. Each treatment session lasts about 30 minutes and uses ultrasound guidance to ensure precise needle placement and safety. During the study, participants will have their pain levels, disability, quality of life, nerve-related pain features, flexibility, movement, pressure sensitivity, and nerve stiffness assessed before and immediately after treatment and again one week later. Researchers will also monitor global improvement and any side effects over an average of two years. The trial uses questionnaires, physical tests like the Straight Leg Raise, and ultrasound elastography imaging to gather detailed information about treatment effects and safety.
CONDITIONS
Brief Title
Immediate and 1-week Efficacy of a Single Session of Sciatic Nerve Electrical Stimulation in the Management of Low-back Related Leg Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Neuropathic-like low-back related leg pain (sciatica)
- S-LANSS pain score of 12 points or higher
- Leg pain lasting more than 6 months
- Severe leg pain in the past 4 weeks limiting daily activities for more than 1 day
- At least one period of 6 months to 1 year with persistent leg pain
- Leg pain intensity of at least 3 out of 10 on the pain scale
- Ability to provide informed consent
You will not qualify if you...
- Recent acute injury or major trauma
- Painful hip joint or pelvic/sacroiliac conditions
- Symptoms indicating cauda equina syndrome (e.g., loss of bladder or bowel control, sexual dysfunction, 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
- Contraindications for invasive physiotherapy or electrotherapy techniques
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session
Participants receive a single session of electrical stimulation or placebo interventions involving needle insertion and/or surface electrodes targeting the sciatic nerve area. The session lasts approximately 30 minutes.
1 treatment visit (in-person)
Duration - 1 week post-intervention
Participants are monitored for pain intensity, disability, quality of life, and other outcomes immediately after treatment and 1 week post-intervention. Adverse events are tracked throughout the study.
2 visits (immediately after treatment and 1 week later)
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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