J Korean Soc Spine Surg.  2005 Dec;12(4):299-309.

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

• Jeon CH
• Kim DJ
• Kim DJ
• Lee HM
• Park HJ
• Kim HS
• Shin DE
• Min HT

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.

Keyword

Chronic low back pain; Tramadol/Acetaminophen; COX-2 inhibitor

MeSH Terms

Cyclooxygenase 2 Inhibitors
Drug-Related Side Effects and Adverse Reactions
Humans
Low Back Pain*
Outcome Assessment (Health Care)
Outpatients
Tablets*
Tramadol*
Celecoxib
Cyclooxygenase 2 Inhibitors
Tablets
Tramadol

Figure

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  Fig. 1. Patient Disposition.

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