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New treatment option for Lumbago
Official title Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study
ClinicalTrials.gov ID: NCT06511765
What this study is testing
What is Ropivacaine and dexamethasone injection solution?
Ropivacaine and dexamethasone injection solution is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for lumbago.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study concerns the treatment of recent lumbago and aims to evaluate the efficacy of an anesthetic block of the erector spinae muscles combining ropivacaine and dexamethasone. This treatment is routinely used in several institutions in France, but has never been the subject of a randomized placebo-controlled study to assess its efficacy at D4 of treatment.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient with lumbago lasting less than 7 days despite analgesic / NSAID treatment.
- Patient with NS pain \> 6
- Patient with Oswestry score \> or equal to 30
- Patient informed of the trial and having signed the informed consent form prior to any trial-specific procedure,
- Patient willing and able to undergo all planned examinations and procedures in compliance with the clinical trial protocol,
You likely can't join if
- Presence of "red flag" (non-disc lumbago):
- Motor deficit or signs of horsetail irritation
- Inflammatory pain waking up in the 2nd half of the night
- Tumoral context
- Infectious context or fever
- Altered general condition
See the full eligibility criteria
- Patient with lumbago lasting less than 7 days despite analgesic / NSAID treatment.
- Patient with NS pain \> 6
- Patient with Oswestry score \> or equal to 30
- Patient informed of the trial and having signed the informed consent form prior to any trial-specific procedure,
- Patient willing and able to undergo all planned examinations and procedures in compliance with the clinical trial protocol,
- Patient affiliated to a social security or any health insurance.
- Presence of "red flag" (non-disc lumbago):
- Motor deficit or signs of horsetail irritation
- Inflammatory pain waking up in the 2nd half of the night
- Tumoral context
- Infectious context or fever
- Altered general condition
- Traumatic context
- Osteoporotic context
- Risk of infection
- Patient with poor local skin condition
- Patient on AVK or anti-Xa anticoagulation, or bleeding disorder (antiaggregants authorized)
- Patients with hypersensitivity to Ropivacaine or any of its excipients: Sodium chloride, hydrochloric acid sodium hydroxide
- Patient with sciatica
- Patient with chronic respiratory insufficiency
- Patient with cardiac rhythm disorders
- Pregnant or breastfeeding woman or woman refusing effective contraception
- Patient deprived of liberty or under legal protection (guardianship or curator)
- Patient participating in another clinical research protocol involving a drug or medical device
- Patient unable to follow the protocol, as judged by the investigator
- Patient refusing to participate in the study
The study team makes the final eligibility decision.
Where it's taking place
- Saint-Herblain, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint-Herblain, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.