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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 / 대한척추외과학회지
Journal of Korean Society of Spine Surgery ; : 299-309, 2005.
Article in Korean | WPRIM | ID: wpr-156374
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.
Subject(s)

Full text: Available Index: WPRIM (Western Pacific) Main subject: Outpatients / Tablets / Tramadol / Outcome Assessment, Health Care / Low Back Pain / Drug-Related Side Effects and Adverse Reactions / Cyclooxygenase 2 Inhibitors / Celecoxib Type of study: Controlled clinical trial Limits: Humans Language: Korean Journal: Journal of Korean Society of Spine Surgery Year: 2005 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Main subject: Outpatients / Tablets / Tramadol / Outcome Assessment, Health Care / Low Back Pain / Drug-Related Side Effects and Adverse Reactions / Cyclooxygenase 2 Inhibitors / Celecoxib Type of study: Controlled clinical trial Limits: Humans Language: Korean Journal: Journal of Korean Society of Spine Surgery Year: 2005 Type: Article