Abstract
STUDY DESIGN: This is a multicenter, open-label prospective, non interventional study. PURPOSE: We wanted to evaluate the impact of fentanyl matrix on the pain and function of patients with spinal disorder-related chronic, non-malignant pain. OVERVIEW OF LITERATURE: Patients with severe non-malignant chronic low back pain may require opioid analgesics for effective pain management. METHODS: A total of 1,576 patients with severe pain (numeric rating scale = 7) were evaluated for their pain intensity at the initial visit and at weeks 4 and 8 (Visits 1, 2, and 3, respectively). Disturbances in sleep, daily living and social activities, the Oswestry Disability Index (ODI), the researchers' and patients' global assessment and the patients' treatment preference were also assessed. RESULTS: The pain intensity score significantly decreased from 8.1 at Visit 1 to 5.4 and 4.4 at Visits 2 and 3, respectively. Sleep disturbance also significantly decreased and the extent of disturbance of daily and social activities was also significantly improved. The ODI significantly decreased from 61.9% to 45.8% and 38.2% at Visits 1, 2, and 3, respectively. Adverse events were reported by 197 (12.5%) patients and severe adverse events were reported by 12 (0.76%) patients. Overall, 76.3% of the patients and 78.4% of the investigators rated the test drug as effective. CONCLUSIONS: The fentanyl matrix is believed to be effective for the treatment of pain, sleep disturbance and the impact upon daily and social activities, yet physicians should pay attention to the risks of abuse and the adverse events.