Immediate and 1-week Efficacy of a Single Session of Sciatic Nerve Electrical Stimulation in the Management of Low-back Related Leg Pain

May 13, 2026 updated by: Universidad Complutense de Madrid
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 immediate and short-term efficacy and safety of a single session 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. 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. The investigators 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. 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. The investigators 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; Flexibility and movement, through the Straight Leg Raise test; Sensitivity to pressure and nerve stiffness, using ultrasound elastography, which is a safe imaging technique; and patients' global impression of improvement and any side effects. Assessments will take place before and immediately after the treatment session and after 1 week, allowing the investigators to see both the immediate and short-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 a single session of PENS 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Gabriel R Rabanal-Rodríguez
          • Phone Number: 0034 91 394 15 24
          • Email: grabanal@ucm.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo PENS + Placebo TENS
Participants will receive only sham interventions. Placebo PENS will be simulated with Streitberger needles (skin contact without penetration) and cable placement, and placebo TENS with adhesive electrodes connected to a disabled channel. Participants will be informed that current is below the sensory threshold. The procedure will last 30 minutes.
Procedure: Placebo Transcutaneous Electrical Nerve Stimulation
Adhesive electrodes will be placed near the intervention site (sciatic nerve between the subgluteal fold and the distal third of the thigh) but connected to a disabled channel to simulate placebo TENS.
Other Names:
  • Placebo TENS
Procedure: Placebo Percutaneous Electrical Nerve Stimulation
A sham ultrasound-guided dry needling procedure will be performed using Streitberger placebo needles, which contact the skin superficially without penetration. Cables for PENS will be placed on the skin but connected to a disabled channel to simulate placebo PENS.
Other Names:
  • Placebo PENS
Experimental: Real PENS + Placebo TENS
Participants will receive real ultrasound-guided dry needle insertion (0.30 mm × 60 mm and 0.30 mm ×50 mm) to the perineural region adjacent to the sciatic nerve at both the subgluteal fold and the posterior thigh (junction between the middle and distal thirds). Electrical stimulation will be applied using the Endomed 484® electrotherapy unit (PRIM Physio, Madrid, Spain) in continuous biphasic mode at low frequency (2 Hz), 250 μs pulse width for 30 minutes. Intensity will be adjusted to elicit a visible, mild muscle contraction. Simultaneously, adhesive electrodes will be placed near the intervention site but connected to a disabled channel to simulate placebo TENS.
Procedure: Percutaneous Electrical Nerve Stimulation
Participants will receive real ultrasound-guided dry needle insertion (0.30 mm × 60 mm and 0.30 mm ×50 mm) to the perineural region adjacent to the sciatic nerve at both the subgluteal fold and the posterior thigh (junction between the middle and distal thirds). Electrical stimulation will be applied using the Endomed 484® electrotherapy unit (PRIM Physio, Madrid, Spain) in continuous biphasic mode at low frequency (2 Hz), 250 μs pulse width for 30 minutes. Intensity will be adjusted to elicit a visible, mild muscle contraction.
Other Names:
  • PENS
Procedure: Placebo Transcutaneous Electrical Nerve Stimulation
Adhesive electrodes will be placed near the intervention site (sciatic nerve between the subgluteal fold and the distal third of the thigh) but connected to a disabled channel to simulate placebo TENS.
Other Names:
  • Placebo TENS
Active Comparator: Real TENS + Placebo PENS
Participants will receive real superficial electrical stimulation via adhesive electrodes connected to the Endomed 484® unit, configured for TENS (non-invasive). Parameters will match those from Group 1 (continuous biphasic current, 2 Hz, 250 μs, 30 min), producing a clear sensory perception and mild muscle contraction. Simultaneously, a sham ultrasound-guided dry needling procedure will be performed using Streitberger placebo needles, which contact the skin superficially without penetration. Cables for PENS will be placed on the skin but connected to a disabled channel to simulate placebo PENS.
Procedure: Transcutaneous Electrical Nerve Stimulation
Participants will receive real superficial electrical stimulation via adhesive electrodes connected to the Endomed 484® unit, configured for TENS (non-invasive). Parameters will include continuous biphasic current, 2 Hz, 250 μs, 30 min, producing a clear sensory perception and mild muscle contraction.
Other Names:
  • TENS
Procedure: Placebo Percutaneous Electrical Nerve Stimulation
A sham ultrasound-guided dry needling procedure will be performed using Streitberger placebo needles, which contact the skin superficially without penetration. Cables for PENS will be placed on the skin but connected to a disabled channel to simulate placebo PENS.
Other Names:
  • Placebo PENS
Active Comparator: Real Dry Needling (without PENS) + Placebo TENS
Participants will receive real ultrasound-guided dry needling as in Group 1 but without electrical stimulation. The needles will remain in place for 30 minutes, with the PENS channel disabled to act as placebo. Simultaneously, adhesive electrodes will be placed as in Group 1, with TENS channels disabled. Participants will be told the current is below the sensory threshold. The design of this intervention group aims to determine whether the therapeutic effects observed with the PENS technique are exclusively due to needle insertion (dry needling) or whether the passage of electrical current through the needle (as in Group 1) plays a decisive role in the outcomes obtained. To this end, real ultrasound-guided dry needling is applied at the same anatomical locations, but without activation of the electrical stimulation channel, the latter acting as a placebo. This comparison will allow the specific effect of electrical stimulation to be isolated within the context of the intervention.
Procedure: Placebo Transcutaneous Electrical Nerve Stimulation
Adhesive electrodes will be placed near the intervention site (sciatic nerve between the subgluteal fold and the distal third of the thigh) but connected to a disabled channel to simulate placebo TENS.
Other Names:
  • Placebo TENS
Procedure: Real Dry Needling (without Percutaneous Electrical Nerve Stimulation)
Participants will receive real ultrasound-guided dry needling but without electrical stimulation. The needles will remain in place for 30 minutes, with the PENS channel disabled to act as placebo.
Other Names:
  • Real Dry Needling (without PENS)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Baseline, immediately after the intervention and 1 week post-intervention.
Pain intensity will be assessed using the NPRS, a single 11-point numerical rating scale widely validated across different patient populations, where 0 represents no pain and 10 represents the worst possible pain. Data obtained through the NPRS are easy to document, intuitively interpretable and meet regulatory requirements for pain assessment and documentation. The NPRS has been shown to be reliable in assessing LBP intensity, also predicting the degree of disability in these patients. A change of 2 points on the NPRS has been considered to reflect the MCID in patients with LBP, indicating that any change equal to or greater than this value can be considered clinically relevant. However, the MCID has not yet been established in patients with LBRLP and neuropathic characteristics; therefore, a variation of 2 points will be used as a reference value, as in patients with LBP and those with chronic pain in general.
Baseline, immediately after the intervention and 1 week post-intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Through study completion, an average of 2 years.
Adverse events will be defined as any problem related to the intervention that causes symptoms lasting at least two days or requiring specific treatment.
Through study completion, an average of 2 years.
Disability
Time Frame: Baseline and 1 week post-intervention.
Disability will be assessed using the Oswestry Disability Index (ODI), an instrument designed to evaluate the degree of disability associated with acute, subacute and chronic LBP. The ODI consists of a total of 10 items, one assessing pain and the remaining nine assessing activities of daily living, each rated on a 6-point ordinal scale ranging from the best to the worst scenario (0-5 points). The scores for each item will be summed to obtain a total between 0 and 50 points, with the following categories: no disability (0-4 points), mild disability (5-14 points), moderate disability (15-24 points), severe disability (25-34 points) and complete disability (35-50 points). The ODI has been shown to be reliable and valid for assessing disability in patients with LBP and has been validated in Spanish. The MCID varies across studies; in this case, the smallest reported value (a change of 5 points) will be used as the reference for significant changes.
Baseline and 1 week post-intervention.
Health-related quality of life
Time Frame: Baseline and 1 week post-intervention.
The SF-12 questionnaire, a shortened version of the SF-36, will be used for this assessment. The SF-12 consists of 12 items that evaluate eight different parameters: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health perception. The items are combined and transformed to provide both a physical and a mental health score, each ranging from 0 (worst) to 100 (best). The SF-12 has been shown to be valid and reliable in populations with chronic LBP. The MCID related to quality of life in patients with LBP has been established as improvements greater than 3.77 points in the mental component and 3.29 points in the physical component.
Baseline and 1 week post-intervention.
Neuropathic component of pain
Time Frame: Baseline and 1 week post-intervention.
This variable will be measured using the S-LANSS pain scale, a self-administered instrument designed to identify patients with pain of neuropathic characteristics. It is a simple scale consisting of seven items with binary responses (yes or no), relating to the presence of symptoms (five items) or clinical signs (two items). The maximum possible score is 24 points, with scores equal to or greater than 12 considered clear indicators of the presence of a neuropathic pain component. The S-LANSS scale has been shown to be reliable for diagnosing pain with neuropathic characteristics and has been validated in Spanish.
Baseline and 1 week post-intervention.
Pressure pain threshold
Time Frame: Baseline, immediately after the intervention and 1 week post-intervention.
To assess PPT a pressure algometer will be used, determining the minimum amount of pressure required for the patient to feel pain. PPT will be measured at three different points on each side: tibial nerve (posterior aspect of the knee), peroneal nerve (at the level of the fibular head), and the sciatic nerve trunk (gluteal region), repeating each measurement three times and averaging the results. According to the classification by Shrout and Fleiss, algometry measurement of PPT at the tibial nerve has shown good intra-rater reliability (ICC = 0.64) and acceptable inter-rater reliability (ICC = 0.56) in asymptomatic individuals. For the peroneal nerve, intra-rater reliability is excellent (ICC = 0.84) and inter-rater reliability is good (ICC = 0.70). For the sciatic nerve, intra-rater reliability is excellent (ICC = 0.90) and inter-rater reliability is good (ICC = 0.75).
Baseline, immediately after the intervention and 1 week post-intervention.
SLR test outcome
Time Frame: Baseline, immediately after the intervention and 1 week post-intervention.
The test will be performed with the participant in a supine position, passively raising the lower limb by flexing the hip while keeping the knee extended. A recent meta-analysis has highlighted ongoing concerns regarding its reliability and diagnostic accuracy, suggesting that incorporating structural differentiation movements may improve its performance. Based on previous research of limited quality, the test has been reported to have high sensitivity and low specificity, although results vary between studies. Likelihood ratios also differ widely across investigations, with LR+ ranging from 1.07 to 4.73 and LR- from 0.27 to 0.96. It has been determined that diagnosing radicular pain and radiculopathy in patients with LBRLP, when based solely on history and physical examination, has only slight inter-rater reliability (Kappa 0.35). In terms of interpretation, the SLR test is considered positive when it elicits familiar symptoms that relieve upon returning to the starting position.
Baseline, immediately after the intervention and 1 week post-intervention.
Pain Descriptors: Familiar Symptomatology and Paresthesias
Time Frame: Baseline, immediately after the intervention and 1 week post-intervention.
Categorical scales will be used to record the extent to which the SLR test reproduces symptomatology recognized by the patient as familiar (not familiar, slightly familiar, considerably familiar or exact reproduction of symptoms) and the severity of any dysesthesias or paresthesias experienced (none, mild-moderate or severe). This questionnaire has demonstrated moderate to excellent inter-rater reliability (ICC = 0.78-0.96).
Baseline, immediately after the intervention and 1 week post-intervention.
Range of motion in hip flexion
Time Frame: Baseline, immediately after the intervention and 1 week post-intervention.
Data on the hip flexion ROM achieved during the SLR test will be collected. The participant will be in a supine position and the hip flexion movement will be recorded using anatomical reference points and assessed using Kinovea, a motion-analysis software. A previous study using this method reported excellent intra- and inter-rater reliability, with ICCs ranging from 0.985 to 0.999 and a minimal detectable change of 1.3-4° of hip flexion in patients with LBP. In contrast, a previous meta-analysis concluded that inter-rater reliability for ROM measurement during the SLR test is poor, with variations ranging from 13° to 20º.
Baseline, immediately after the intervention and 1 week post-intervention.
Sciatic nerve stiffness
Time Frame: Baseline, immediately after the intervention and 1 week post-intervention.
An experienced ultrasound researcher will perform shear wave elastography (SWE) to assess sciatic nerve stiffness using a Logiq P9 XDclear™ system with convex (1-6 MHz) and linear (6-15 MHz) probes. Exams will be bilateral in the subgluteal fossa, with participants prone, ankle neutral, and knee extended. The nerve will be identified axially for thickness, width and area, then imaged longitudinally for SWE. Stable transducer positioning will allow simultaneous B-mode and SWE display. Stiffness will be expressed in kPa, taking at least three measurements that will be averaged for analysis. All images will be acquired by the same investigator. This method shows good reliability (ICC = 0.869), and higher stiffness (≈11.3%) has been observed in affected legs of patients with LBRLP compared to their unaffected side and to healthy controls.
Baseline, immediately after the intervention and 1 week post-intervention.
Global perceived improvement
Time Frame: Immediately after the intervention and 1 week post-intervention.
Global perceived improvement will be measured using a 7-point Likert scale ranging from "much worse" to "much better." Clinical improvement will be considered in participants who report feeling "moderately better" or "much better".
Immediately after the intervention and 1 week post-intervention.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sociodemographic variables
Time Frame: Baseline.
Sociodemographic data will be collected using a standardized form in which participants will be required to provide their age, gender, occupation, height, weight, ethnicity, education level, comorbidities, history of sports activity, symptoms in other joints, duration of symptoms and medication use.
Baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Complutense de Madrid

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Colegio de Fisioterapeutas de la Comunidad de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25/504-E (IMM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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