ANALGESIC EFFICACY OF TRAMADOL/ ACETAMINOPHEN COMBINATION WITH DICLOFENAC SODIUM IN MODERATE TO SEVERE LOW BACK PAIN

Abstract

This prospective randomized cohort study was conducted in two parallel groups to compare the analgesic effects in conventional use of oral Diclofenac tablet, 50 mg tablet three times daily or 75 mg tablet twice daily (DIC group) with oral combination of Tramadol 37.5 mg and Acetaminophen (Paracetamol) 325 mg (T-APAP group) one tablet twice daily. The number of patients n= 150 in each group. Study data of total 300 patients of age 20 - 60 years, with moderate to severe Low back pain (LBP) was collected from the public and two private setup OPDs in Karachi, Pakistan. Patient demographic data of gender, age, BMI and socioeconomic status were collected. Numeric Pain Rating Scale (NPRS) was used to measure pain intensity and overall pain intensity at the baseline 0, 1st, 2nd, 3rd and 4th week of the treatment. The results indicated that the incidence of Low back pain (LBP) is highest 41.0 % (n = 123) in 30-39 years age group. According to Body Mass Index (BMI) classification most of the patients 63.6 % (n = 191) patients are overweight. In socioeconomic classification 47.3 % (n = 142) are from lower socioeconomic status. The duration of perceived pain was found to be shorter with 58.6 % (n = 88) recovery within one week of the treatment in the T-APAP Group, compared to 35.3 % (n = 53) recovery in DIC group (p< 0.05). Oral combination of Tramadol plus Paracetamol is found to be more effective than the use of oral Diclofenac alone. 79.4 % Overall Pain Relief with 5.8 scores of Overall Pain Relief (p< 0.05) were observed in the T-APAP Group. It is concluded that the oral combination of Tramadol 37.5 mg and Acetaminophen (Paracetamol) 325 mg is more effective analgesic than oral use of Diclofenac sodium alone in moderate to severe LBP.