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

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: Not yet recruiting
• Conditions: Lower Back Pain Chronic
• Intervention / Treatment: Procedure: Stimulation with TENS, which allows the release of endorphins; Other: Questionnaires; Procedure: Stimulation with TENS does not allow the release of endorphins

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc LABROUSSE, MD; Phone Number: +33 06 21 41 75 03; Email: labrousse.m@chu-toulouse.Fr

Study Locations

• France
  • Toulouse, France, 31300
    • Service de Neurologie, Hôpital Pierre Paul Riquet, Place du Docteur Baylac
    • Contact: Emeline MULLER; Phone Number: +33 0561778707; Email: muller.E@chu-toulouse.Fr

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	Pain assessment using the visual analog scale	3 months after the inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of satisfaction with the infiltration procedure in both groups	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	Pain questionnaires to be completed	3 months after the inclusion
Assessment of pain experienced by the patient in the 2 groups	Questionnaire on the reduction of perceived pain	3 months after the inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pain; chronic lower back pain; transcutaneous electrical neurostimulation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Surveys and Questionnaires; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: RC31/24/0576; ID-RCB (Other Identifier: 2025-A02239-40)

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