Emerald Coast Clinic
St-Malo, 35400, France
NCT Number: NCT07555496
Chronic low back pain represents a major public health issue, with an estimated prevalence of up to 23% in the adult population and a significant impact on quality of life and functional capacity. Among these patients, a significant proportion undergo spinal surgery-including laminectomy, discectomy, or spinal fusion-when conservative treatment has failed to provide adequate relief. Current treatment strategies involve functional spinal rehabilitation (FSR). Due to the multifaceted and complex pathophysiology of this chronic pain condition, we have previously addressed the spinal syndrome in terms of its functional and muscular component: the myofascial expression. In our clinical practice, we have introduced a minimally invasive paravertebral procedure, guided by ultrasound, targeting the fascia of the erector spinae muscles in the lower lumbar region. The goal of this procedure is to provide pain relief to the patient, enabling them to better adhere to the rehabilitative treatment (functional restoration of the spine) and ultimately improve the patient's quality of life within their environment. This evaluation of professional practices highlights a clear clinical indication in favor of infiltration of the erector spinae fascia, with a significant majority of patients reporting improved pain relief and better adherence to rehabilitation.
Thus, within a coordinated, multidisciplinary care approach, this intervention appears to address patient expectations regarding comfort and leads us to consider the myofascial component of the complaint. The proposed paravertebral intervention is also appropriate in accordance with the updated recommendations, which are very restrictive in the context of a surgically treated spine (PSPS-2). This assessment of current practices justifies the implementation of a prospective controlled study. Through this study, we aim to investigate the treatment's effects and evaluate its pharmacological (via the anti-inflammatory action of corticosteroids) and mechanical (via needle-induced muscle stimulation) components.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
St-Malo, 35400, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injection of half a vial of Diprostene 1.5 mL + Lidocaine 1.5 mL-under ultrasound guidance-targeting the erector spinae muscles medial to the posterior superior iliac spine-bilaterally
Dry needle insertion guided by ultrasound, with manipulation targeting the spinal erector muscles medial to the posterior superior iliac spine-on both sides.
simulated procedure (non-invasive puncture with a stylet in the lower lumbar region, medial to the posterior superior iliac spine-on both sides).
Time frame: between day 0 (intervention) and 3 months after intervention
assessed by Oswestry disability index (ODI)
Time frame: day 0, 1 month, 3 months
Assessed by visual analogic scale (VAS) for pain, from 0 (no pain) to 10 (worst pain)
Time frame: Day 0, 1 month, 3 months
Measured by Study Questionnaire Short Form 36 Health Survey (SF-36) : The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 (Lower scores = more disability, higher scores = less disability)
Time frame: Day 0, 1 month, 3 months
muscle and functional performance measured using metrological score SHIRADO ITO
Time frame: Day 0, 1 month, 3 months
Assessed by Fear Avoidance Belief Questionnaire (FABQ) : The complete FABQ is administered as a single 16-item questionnaire. Patients rate each item on a 7-point scale: 0 = completely disagree, 6 = completely agree.
Contact information is provided by the study sponsor or research team.
Clinique de la Côte d'Emeraude
Other
Acronym: SPIN-NEED
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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