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

Official 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

Overview

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.

Interventions

• Procedure Stimulation with TENS, which allows the release of endorphins
  Stimulation with TENS at frequencies that allow the release of endorphins before infiltration
• 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
• Other Questionnaires
  Pain questionnaires will need to be completed at the inclusion, one month and 3 months

Primary outcome measures

• 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]

Secondary outcome measures (3)

• Evaluation of satisfaction with the infiltration procedure in both groups [Time frame: 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]
• Assessment of pain experienced by the patient in the 2 groups [Time frame: 3 months after the inclusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

France · 1 center

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

Identifiers

NCT: NCT07627490 · RC31/24/0576 · ID-RCB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗