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NCT Number: NCT07627490

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

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.

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Key information

Conditions

Lower Back Pain Chronic Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Neurologie, Hôpital Pierre Paul Riquet, Place du Docteur Baylac

Toulouse, 31300, France

Location contact

Emeline MULLER

CONTACT

[email protected]

0561778707 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stimulation with TENS, which allows the release of endorphins

Procedure

Stimulation with TENS at frequencies that allow the release of endorphins before infiltration

Stimulation with TENS does not allow the release of endorphins

Procedure

Stimulation with TENS at levels that do not allow the release of endorphins prior to infiltration

questionnaires

Other

Pain questionnaires will need to be completed at the inclusion, one month and 3 months

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Marc LABROUSSE, MD

CONTACT

[email protected]

06 21 41 75 03 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: TENS-INFIDOL

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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