efficacy and safety in the combination of celecoxib / pregabalin / vitamin b for low back chronic pain

Conditions: Chronic Low-back Pain

Summary: phase iii longitudinal, multicenter, randomized, double-blind clinical trial. the aim of this study is to evaluate the efficacy and security of the drug combination of celecoxib / pregabalin / vitamin b versus celecoxib + vitamin b, versus pregabalin + vitamin b in the treatment of chronic low back pain.

researchers will compare the fixed-dose combination of celecoxib/pregabalin/vitamin b versus celecoxib + vitamin b versus pregabalin + vitamin b for chronic low back pain. the adverse events related to the interventions would be registered in each follow up visit. participants will: * be randomized into one of the 3 intervention groups (a,b,c) once a day for 12 weeks * if needed the dose could be escaleted twice a day. * visit the clinic at weeks 2, 4, 8 and 12 for checkups and follow up

Eligibility criteria:
inclusion criteria: * agree to participate in the study and give written informed consent * subjects must have chronic low back pain with a high probability of a significant neuropathic component during 4 years or less (but not less than 3 months) * patients with chronic low back pain reported as moderate to severe intensity (eva ≥ 40 mm) * patients with neuropathic pain questionnaire (dn4) result ≥ 4 * 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 whose 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 * 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.) * current treatment with opioids and/or nsaids including cox-2 inhibitors (except celecoxib), reported in clinical history in the last 24 hours to the signing of the informed consent * patients who are receiving monoamineoxidase inhibitors (maois) or who have received them in the course of the 2 weeks prior to signing the informed consent * 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 * history of major trauma to the lower back in the past 14 days * low back pain due to a visceral disorder (e.g., dysmenorrhea, history of endometriosis) * patients with a history of orthopedic surgery of the lumbar region secondary to chronic low back pain * 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: low-back pain chronic pain vitamin b pregabalin celecoxib