Lower Back Pain ChronicTENS-INFIDOLNCT07627490
The Potential of Transcutaneous Electrical Nerve Stimulation to Improve Pain Experienced During Posterior Branch Blocks in Patients With Lumbar Posterior Joint Syndrome
A study testing Stimulation with TENS, which allows the release of endorphins, Stimulation with TENS does not allow the release of endorphins and Questionnaires in people with Lower Back Pain Chronic, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Back Pain Chronic
- What is being tested?
- Stimulation with TENS, which allows the release of endorphins, Stimulation with TENS does not allow the release of endorphins and Questionnaires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Spinal surgery
- Contraindications for TENS:
- Wearing an electronic medical device (pacemakers, defibrillators, etc.)
- Pregnancy
- Area of cutaneous anesthesia
- Patient with an active malignant tumor
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service de Neurologie, Hôpital Pierre Paul Riquet, Place du Docteur Baylac
Toulouse, 31300
Emeline MULLER, 0561778707 ext. +33, muller.E@chu-toulouse.Fr
About this study
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
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
- Being tested
- Stimulation with TENS, which allows the release of endorphins, Stimulation with TENS does not allow the release of endorphins, Questionnaires
- Keywords
- chronic lower back pain, pain, transcutaneous electrical neurostimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation with TENS, which allows the release of endorphinsProcedure or surgery
Stimulation with TENS at frequencies that allow the release of endorphins before infiltration
Stimulation with TENS does not allow the release of endorphinsProcedure or surgery
Stimulation with TENS at levels that do not allow the release of endorphins prior to infiltration
QuestionnairesOther
Pain questionnaires will need to be completed at the inclusion, one month and 3 months
| Study group | Role | What they receive |
|---|---|---|
| Interventional group with TENS in gate control mode | Experimental | Interventional group using TENS in gate control mode to allow the release of endorphins Receives: 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 Receives: Procedure: Stimulation with TENS does not allow the release of endorphins; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after the inclusion
Secondary outcomes (3)
Evaluation of satisfaction with the infiltration procedure in both groups
Satisfaction questionnaire to be completed regarding the infiltration procedure
Measured: 3 months after the inclusion
Comparison of the effectiveness of posterior branch block on pain in both groups
Pain questionnaires to be completed
Measured: 3 months after the inclusion
Assessment of pain experienced by the patient in the 2 groups
Questionnaire on the reduction of perceived pain
Measured: 3 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back Pain ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627490
- Sponsor's protocol ID
- RC31/24/0576
- Other IDs
- ID-RCB
- Acronym
- TENS-INFIDOL
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07627490
- Acronym / sponsor ID
- TENS-INFIDOL / RC31/24/0576
- Conditions
- Lower Back Pain Chronic
- Keywords
- chronic lower back pain, pain, transcutaneous electrical neurostimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group with TENS in gate control mode | Experimental | Procedure: Stimulation with TENS, which allows the release of endorphins, Other: QuestionnairesInterventional group using TENS in gate control mode to allow the release of endorphins |
| Control group using TENS with placebo stimulation | Active comparator | Procedure: Stimulation with TENS does not allow the release of endorphins, Other: QuestionnairesControl group using TENS with placebo stimulation that does not release endorphins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Spinal surgery
- Contraindications for TENS:
- Insulin-dependent or uncontrolled diabetes
- Uncontrolled hypertension
- Allergy to the local anesthetics used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulation with TENS, which allows the release of endorphinsStimulation with TENS at frequencies that allow the release of endorphins before infiltration | Procedure or surgery | Interventional group with TENS in gate control mode |
| Stimulation with TENS does not allow the release of endorphinsStimulation with TENS at levels that do not allow the release of endorphins prior to infiltration | Procedure or surgery | Control group using TENS with placebo stimulation |
| QuestionnairesPain questionnaires will need to be completed at the inclusion, one month and 3 months | Other | Control group using TENS with placebo stimulation, Interventional group with TENS in gate control mode |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation with TENS, which allows the release of endorphins, Stimulation with TENS does not allow the release of endorphins and Questionnaires in people with Lower Back Pain Chronic, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc LABROUSSE, MD (06 21 41 75 03 ext. +33, labrousse.m@chu-toulouse.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.