Efficacy and Safety in the Combination of Celecoxib / Pregabalin / Vitamin B for Low Back Chronic Pain

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 significantneuropathic 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 investigationaltreatment or participation in one within 4 weeks prior to study start

• Patients whose participation in the study may be influenced (employment relationshipwith the research site or sponsor, inmates, etc.)

• At medical discretion, a disease that affects prognosis and prevents outpatientmanagement, for example, but not limited to: end-stage cancer, kidney, heart,respiratory or liver failure, mental illness or with scheduled surgical or hospitalprocedures

• History/presence of any disease or condition that, in the opinion of theInvestigator, could pose a risk for the patient or confusing the efficacy and safetyof 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 studydrugs, related products or excipients

• Pregnant women, women breastfeeding or planning a pregnancy during the conductingthe study

• Significant history of gastrointestinal diseases (e.g., gastric ulcer, Crohn'sdisease, Ulcerative Colitis, etc.)

• Current treatment with opioids and/or NSAIDs including COX-2 inhibitors (exceptcelecoxib), reported in clinical history in the last 24 hours to the signing of theinformed consent

• Patients who are receiving monoamineoxidase inhibitors (MAOIs) or who have receivedthem 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/orcerebral vascular disease (including patients who have recently undergone coronaryrevascularization 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 diseaseor 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 ofendometriosis)

• Patients with a history of orthopedic surgery of the lumbar region secondary tochronic 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