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

NCT07627490 | Not Yet Recruiting DMC

• 2 other identifiers: RC31/24/0576ID-RCB
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Back Pain Chronic

Keywords

chronic lower back pain; pain; transcutaneous electrical neurostimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluation of satisfaction with the infiltration procedure in both groups

  3 months after the inclusion

• Comparison of the effectiveness of posterior branch block on pain in both groups

  3 months after the inclusion

• Assessment of pain experienced by the patient in the 2 groups

  3 months after the inclusion

Study Arms (2)

Interventional group with TENS in gate control mode

EXPERIMENTAL

Interventional group using TENS in gate control mode to allow the release of endorphins

Procedure: Stimulation with TENS, which allows the release of endorphins; Other: Questionnaires

Control group using TENS with placebo stimulation

ACTIVE COMPARATOR

Control group using TENS with placebo stimulation that does not release endorphins

Procedure: Stimulation with TENS does not allow the release of endorphins; Other: Questionnaires

Interventions

Stimulation with TENS, which allows the release of endorphins PROCEDURE

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

Interventional group with TENS in gate control mode

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

Control group using TENS with placebo stimulation

Questionnaires OTHER

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

Control group using TENS with placebo stimulation; Interventional group with TENS in gate control mode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

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

Toulouse, 31300, France

Location

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Marc LABROUSSE, MD

CONTACT

06 21 41 75 03; labrousse.m@chu-toulouse.Fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)