Clinical Research Directory

The Effect of Pregabalin and Etoricoxib on Pain Alone Versus in Combination

Sponsor: Muhammad Ilyas

Summary

To determine the effects of pregabalin in reducing pain intensity and improving functional disability in patients with chronic low back pain of neuropathic origin when used in combination with Etoricoxib. Hypothesis Pregabalin-etoricoxib combination is more effective than etoricoxib monotherapy in reducing pain and improving functional status in patients with chronic low back pain. Null Hypothesis: There is no significant difference between pregabalin-etoricoxib combination and etoricoxib monotherapy in reducing pain and improving functional status in patients with chronic low back pain. Study Design: Comparative clinical study Setting: Watim General Hospital Duration of study: 18 months after ethical approval Sample Size: a previous study (8), was used to calculate the sample size, Using the WHO sample size calculator, a sample size of 140 patients (70 in each group) was determined with a 5% level of significance and 95% power of test. Sampling Technique: non-probability convenience sampling. Sample selection 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 * No experience of previous low back surgery 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 Data collection Participants will be divided into two study groups. Group A (n=70) participant will receive 60mg Etoricoxib once daily along with a placebo and Group B (n=70) participants will also receive etoricoxib 60mg once daily(15) along with a placebo for 4 weeks. At the start of week 5 the group B will start taking Pregabalin 75mg along with Etoricoxib 60mg once daily for next 4 weeks, while, group A will continue same treatment as before. At Weeks 0 and 4 and 8 of the study, participants will be evaluated. Liver enzyme levels will be measured both at the beginning and end of the trial. The pain will be measured using numeric rating scale (NRS). CLBP-related impairment will be evaluated using the self-reported 24-item Roland-Morris impairment Questionnaire (RMDQ)

Official title: The Effect of Low Dose Pregabalin and Etoricoxib Combination on Pain in Comparison to Etoricoxib Alone in Patients Suffering From Chronic Low Back Pain

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