The Effect of Low Dose Pregabalin and Etoricoxib Combination on Pain in Comparison to Etoricoxib Alone in Patients Suffering From Chronic Low Back Pain
etoricoxib 60mg
Treatment Study
Summary
Study start date: June 1, 2024
Actual date on which the first participant was enrolled.This clinical study is exploring how effective a combination of two medications, Pregabalin and Etoricoxib, is in reducing pain for people suffering from chronic low back pain. Chronic low back pain is a persistent and often debilitating condition affecting a significant portion of the population, especially those over the age of 50. The study aims to find better treatment methods as many current options do not effectively address all types of pain associated with this condition, particularly neuropathic pain. By utilizing Pregabalin, which targets nerve pain, alongside Etoricoxib, the study seeks to improve pain management and reduce disability for those affected. Participants in the study are divided into two groups. Initially, all participants receive Etoricoxib and a placebo for four weeks. After this period, one group continues with only Etoricoxib, while the other group begins taking Pregabalin in addition to Etoricoxib for another four weeks. The effectiveness of the treatment is evaluated by checking pain levels using a numeric scale and assessing how much the pain impacts daily activities. The study also measures liver enzyme levels to monitor any potential side effects. Additionally, the participants' overall impression of their improvement is recorded. These results help determine whether the combination of these medications provides a significant improvement in managing chronic low back pain compared to Etoricoxib alone.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.140 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * Participants within age 20-65 years * Both male and non-pregnant non-lactating female patients will be included in the study * Patients experiencing CLBP symptoms from last 6 months Exclusion Criteria: * • Patients with the history of antidepressant, opioid, and benzodiazepine medications * Patients with the history of CYP1A2 inhibitors usage * Patients already taking pregabalin * Patients with the history of suicidal ideation, severe depression, anxiety disorder psychosis, and cognitive impairment
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives