Lower Back Pain Chronic
Conditions
Keywords
chronic lower back pain, pain, transcutaneous electrical neurostimulation
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.
Interventions
PROCEDUREStimulation with TENS, which allows the release of endorphins
Stimulation with TENS at frequencies that allow the release of endorphins before infiltration
PROCEDUREStimulation 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
OTHERQuestionnaires
Pain questionnaires will need to be completed at the inclusion, one month and 3 months
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the intensity of pain experienced during the infiltration procedure between the intervention group and the placebo group | 3 months after the inclusion | Pain assessment using the visual analog scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of satisfaction with the infiltration procedure in both groups | 3 months after the inclusion | Satisfaction questionnaire to be completed regarding the infiltration procedure |
| Comparison of the effectiveness of posterior branch block on pain in both groups | 3 months after the inclusion | Pain questionnaires to be completed |
| Assessment of pain experienced by the patient in the 2 groups | 3 months after the inclusion | Questionnaire on the reduction of perceived pain |
Countries
France
Contacts
CONTACTMarc LABROUSSE, MD
Outcome results
None listed