The Potential of Transcutaneous Electrical Nerve Stimulation to Improve Pain Experienced During Posterior Branch Blocks in Patients With Lumbar Posterior Joint Syndrome (TENS-INFIDOL)

May 29, 2026 updated by: University Hospital, Toulouse

The Value of Transcutaneous Electrical Nerve Stimulation (TENS) for Improving Pain Experienced During Posterior Branch Blocks in Patients With Lumbar Posterior Joint Syndrome: a Single-center, Randomized, Double-blind, Parallel-group, Controlled, Superiority Trial

Procedural pain is inadequately managed in two-thirds of patients undergoing invasive medical procedures. Several techniques exist for managing procedural pain, but they all present implementation challenges and are not without side effects. Therefore, a new, non-pharmacological, inexpensive, and easy-to-use approach would be of significant benefit. Transcutaneous electrical nerve stimulation (TENS) for pain relief could represent this alternative. Few studies have been conducted on the benefits of TENS in managing procedural pain, for example, in shoulder arthrodistension. This project proposes to study it in the context of posterior ramus infiltration in patients eligible for this indication, in the context of chronic low back pain associated with posterior joint syndrome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.
52

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Toulouse, France, 31300
        • Service de Neurologie, Hôpital Pierre Paul Riquet, Place du Docteur Baylac
        • Contact:

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:

  • Chronic low back pain (lasting more than 3 months)
  • Patient followed in a Chronic Pain Unit (CETD, Toulouse University Hospital)
  • Clinical and radiological diagnosis (CT scan or MRI) of posterior joint syndrome
  • Patient with an indication for infiltration therapy, feasible under standard conditions

Exclusion Criteria:

  • Spinal surgery

  • Contraindications for TENS:

    • Wearing an electronic medical device (pacemakers, defibrillators, etc.)
    • Pregnancy
    • Area of cutaneous anesthesia
    • Patient with an active malignant tumor
    • Patient with deep vein thrombosis
    • Patient with damaged or fragile skin
  • Insulin-dependent or uncontrolled diabetes
  • Uncontrolled hypertension
  • Allergy to the local anesthetics used
  • Severe psychiatric disorder
  • Lumbar injection within the previous 6 months

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Experimental: Interventional group with TENS in gate control mode
Interventional group using TENS in gate control mode to allow the release of endorphins
Procedure: Stimulation with TENS, which allows the release of endorphins
Stimulation with TENS at frequencies that allow the release of endorphins before infiltration
Other: Questionnaires
Pain questionnaires will need to be completed at the inclusion, one month and 3 months
Active Comparator: Control group using TENS with placebo stimulation
Control group using TENS with placebo stimulation that does not release endorphins
Other: Questionnaires
Pain questionnaires will need to be completed at the inclusion, one month and 3 months
Procedure: Stimulation with TENS does not allow the release of endorphins
Stimulation with TENS at levels that do not allow the release of endorphins prior to infiltration

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
Comparison of the intensity of pain experienced during the infiltration procedure between the intervention group and the placebo group
Time Frame: 3 months after the inclusion
Pain assessment using the visual analog scale
3 months after the inclusion

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
Evaluation of satisfaction with the infiltration procedure in both groups
Time Frame: 3 months after the inclusion
Satisfaction questionnaire to be completed regarding the infiltration procedure
3 months after the inclusion
Comparison of the effectiveness of posterior branch block on pain in both groups
Time Frame: 3 months after the inclusion
Pain questionnaires to be completed
3 months after the inclusion
Assessment of pain experienced by the patient in the 2 groups
Time Frame: 3 months after the inclusion
Questionnaire on the reduction of perceived pain
3 months after the inclusion

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.
University Hospital, Toulouse

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 (Estimated)

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.
September 1, 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.
September 1, 2028

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).
May 29, 2026

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.
May 29, 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.
June 4, 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.
June 4, 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 29, 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.
May 1, 2026

More Information

Terms related to this study

Keywords

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.
  • RC31/24/0576
  • ID-RCB (Other Identifier: 2025-A00414-45)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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