efficacy and safety of etoricoxib/cyanocobalamin versus etoricoxib for acute low back pain

Conditions: Acute Low-back Pain

Summary: phase iii longitudinal, multicenter, randomized, double-blind clinical trial. the aim of this study is to evaluate the efficacy and safety of the fixed-dose combination of etoricoxib/cyanocobalamin versus etoricoxib in patients with acute low back pain

researchers will compare the fixed-dose combination of etoricoxib/cyanocobalamin versus etoricoxib in acute low back pain by comparing the proportion of patients that reported an improvement in pain during the 7 days of follow up. the adverse events related to the interventions will be registered during follow up. participants will: * be randomized into one of the 2 intervention groups (a or b) * visit the clinic in 3 occasions (day 0, day 3 of follow up and day 7 of follow up) * in case needed the patient could take 50 mg of tramadol, as a rescue medication, previous authorization of de principal investigator

Eligibility criteria:
inclusion criteria: * agree to participate in the study and give written informed consent * patient with pain reported as moderate to severe intensity with ≥ 40 mm on the visual analog scale (vas). * at least 4 points on the "douleur neuropathique-4 items" (dn-4) scale. * diagnosis of acute low back pain as a first-time episode or a previous episode 6 months before the enrollment day and lasting no more than 6 weeks. * women of childbearing potential under a medically acceptable method of contraception exclusion criteria: * patients participating in another clinical trial involving an investigational treatment or participation in one within 4 weeks prior to study start * patients in whom the participation in the study may be influenced (employment relationship with the research site or sponsor, inmates, etc.) * at medical discretion, a disease that affects prognosis and prevents outpatient management, for example, but not limited to: end-stage cancer, kidney, heart, respiratory or liver failure, mental illness or with scheduled surgical or hospital procedures * history/presence of any disease or condition that, in the opinion of the investigator, could pose a risk for the patient or confusing the efficacy and safety of the investigational product * patients in whom the study drug is contraindicated for medical reasons * patients with allergy or hypersensitivity to the active substance of the study drugs, related products or excipients (etoricoxib of cyanocobalamin) * pregnant women, women breastfeeding or planning a pregnancy during the conducting the study * significant history of gastrointestinal diseases (e.g., gastric ulcer, crohn's disease, ulcerative colitis, etc.) * active opioid and/or nsaid treatment including cox-2 inhibitors, reported in the medical record within the last 72 hours of study entry. * patients with a history of congestive heart failure: nyha ii-iv. * concomitant use of strong cyp1a2 inhibitors (e.g., fluvoxamine, ciprofloxacin, etc.). * patients with a history of alcohol or drug abuse in the last year * patients with a history of ischemic heart disease, peripheral artery disease, and/or cerebral vascular disease (including patients who have recently undergone coronary revascularization or angioplasty) * patients with a history of seizures, epileptic status and/or grand mal seizures * history of chronic liver failure child-pugh a, b, and/or c * history of acute renal failure (glomerular filtration rate \<30 ml/min/1.72 m2) * patient with a history of chronic pain associated with fibromyalgia, paget's disease or bone pain induced by metastatic cancer * low back pain due to a history of major trauma in the past 12 months (e.g., vertebral fracture, post-traumatic spondylolisthesis) or due to a visceral disorder (e.g., dysmenorrhea, history of endometriosis). * patients with symptoms suggestive of covid-19 infection (fever, cough, dyspnea) and/or contact in the last 14 days with a suspected or positive patient for covid-19

Keywords: acute low -back pain acute pain etoricoxib cyanocobalamin