Comparative Study of the Safety and Effectiveness of Tramadol 37.5 mg/Acetaminophen 325 mg Combined Tablets and Cyclo-Oxygenase-2 (Celecoxib) Inhibitor for the Treatment of Chronic Low Back Pain: A Multicenter, Randomized, Comparative Clinical Study.
10.4184/jkss.2005.12.4.299
- Author:
Chang Hoon JEON
1
;
Dong Jae KIM
;
Dong Jun KIM
;
Hwan Mo LEE
;
Heui Jeon PARK
;
Hak Sun KIM
;
Dong Eun SHIN
;
Han Ter MIN
Author Information
1. Department of Orthopedic Surgery, Ajou University School of Medicine, Suwon, Korea. chjeon@ajou.ac.kr
- Publication Type:Comparative Study ; Multicenter Study ; Original Article ; Randomized Controlled Trial
- Keywords:
Chronic low back pain;
Tramadol/Acetaminophen;
COX-2 inhibitor
- MeSH:
Cyclooxygenase 2 Inhibitors;
Drug-Related Side Effects and Adverse Reactions;
Humans;
Low Back Pain*;
Outcome Assessment (Health Care);
Outpatients;
Tablets*;
Tramadol*;
Celecoxib
- From:Journal of Korean Society of Spine Surgery
2005;12(4):299-309
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
STUDY DESIGN: This is a multicenter, randomized comparative outpatient study on a 8-week administration of Tramadol 37.5 mg/Acetaminophen and 325 mg (Tramadol/APAP) combination tablets and Cyclo-Oxygenase-2 inhibitor (Celecoxib). OBJECTIVES: We wanted to evaluate the efficacy and safety of Tramadol/APAP combination tablets and Celecoxib for the treatment of chronic low back pain. SUMMARY OF THE LITERATURE REVIEW: Tramadol/APAP combination tablets have an analgesic efficacy for the treatment of chronic low back pain. The conditions for which COX-2 inhibitors were be used included a variety of musculoskeletal conditions. However, further analyses are needed to determine the efficacy and safety of Tramadol/APAP combination tablets and Celecoxib for the treatment of chronic low back pain. MATERIALS AND METHODS: One hundred twenty-five patients with chronic low back pain (pain visual analogue scale [VAS] scores >40 mm on 100 mm scale) were randomized to take the Tramadol/APAP combination tablets or Celecoxib for 8 weeks. The primary outcome measure was the pain VAS score, pain relief score and the Korean-version of Oswestry Disability Index (KODI). RESULTS: The study enrolled 125 patients (56 in the Tramadol/APAP tablets group and 69 in the Celecoxib group). There were no significant differences between Tramadol/APAP combination tablets and Celecoxib with regard to the pain VAS scores (VAS; 27.99+/-21.22 vs 24.56+/-16.58, respectively, p>0.05), the pain relief score and the mean decreased disability score on the KODI (0.42+/-0.59 vs 0.46+/-0.05, respectively). The adverse drug reactions showed a statistically significant difference (p<0.05). CONCLUSIONS: The results of this study suggest that Tramadol/APAP combination tablets are just as effective as celecoxib for relieving chronic low back pain.
