Design and population
tumor, Pain, anxiety, stroke, allergy, psychiatric, neurological diseases, Depression, Anxiety, fracture, radiculitis, depressive disorders, Oswestry Disability, infection, LMBB, hematoma, LBP, scoliosis, pain, Parkinson’s disease, LFJ
TUMOR, INFILTRATION, NEUROLOGICAL DISEASE, ANKYLOSING SPONDYLITIS, SCOLIOSIS, ADVERSE EVENTS, STROKE, ALLERGY, DISORDERS, RADICULITIS, SPINAL INSTABILITY, INFECTION, SYSTEMIC INFECTION, SYNDROME, COAGULATION DISORDER, HEMATOMA, VASOVAGAL SYNCOPE
This prospective multicenter randomized controlled trial was conducted from 6 January 2021 until 10 March 2022 in three pain management centers in Brussels (Belgium); Saint-Pierre University Hospital (César de Paepe site), Erasme and Braine-l’Alleud Hospitals. This open label study was approved by the three Ethics Committees of ULB (main center is Erasme Hospital; P2020/557, 31th of December 2020 - B4062020000221) and was registered on the publicly accessible Clinical Trial Registry (NCT04658953, 09/12/2020).All participants received and signed an informed consent before the infiltration including all the information about the procedure, the benefits and the possible risks (hematoma, infection, vasovagal syncope, intrathecal injection and spinal anesthesia). Allocation concealment was achieved using opaque numbered sealed envelopes, opened only after each patient’s arrival in the operating theatre, in each center. Patients beneficiated the FS or the US technique, according to the randomization and both the attending anesthetist and the patient were aware of the allocated technique. All patients enrolled in the study were requested to report to investigators the evolution of the applied scores variables by phone at the predetermined time points.Inclusion criteria: patients aged between 20 and 80 years old, having a chronic LBP compatible with a LFJ syndrome for at least 3 months without response to a conservative treatment of minimum 4 weeks.Exclusion criteria: refusal to participate to the study, pregnant or breastfeeding women, allergy to injected products (Methylprednisolone (Depomedrol) or Lidocaine (Linisol)), psychiatric disorders hindering understanding of the protocol, local or systemic infection or coagulation disorder. In addition, patients should not present any sign of dissociated pain, radiculitis, neurological diseases (including stroke, Parkinson’s disease), spinal instability or deformities (such as scoliosis, ankylosing spondylitis), history of lumbar surgery, fracture or lumbar tumor. Further, patients with a body mass index (BMI) > 35 kg/mFor this study, the investigators have blocked the LMBB on three lumbar levels (L3-L4, L4-L5 and L5-S1) performed under US versus FS according to a transverse approach. The aim was to compare the equivalence of these two modalities by the evaluation of the benefit of the procedures on pain with a Visual Analogue Pain Scale (VAPS), the evolution of the possibility of carrying out daily activities with the Duke’s Activity Status Index (DASI) and the limits of daily activities with the Oswestry Disability Index (ODI). Scores were collected before injection, 1 week and 1 month after. Hospital Anxiety and Depression Scale (HADS) before the procedure was also filled to detect anxiety and depressive disorders in the setting of the treatment of pain arising from the lumbar facet joints. Moreover, duration of the procedures, incidence of adverse events, work status and medications were obtained