Objective of this prospective, non-interventional study was to obtain data under a therapy with oral osmotic hydromorphone (OROS) in patients with chronic severe pain due to osteoarthritis under daily routineconditions.
Using the Brief Pain Inventory (BPI) patients assessed pain relief as well as the impact of pain on activities of daily living. Pain control, treatment satisfaction (by patient and investigator), physical therapy capability and the WOMAC-Index (Western Ontario and McMaster Universities Osteoarthritis) were additionally evaluated. Adverse events were continuously monitored throughout the study.
206 patients with chronic severe pain due to osteoarthritis and an initial pain intensity of 6 (NRS 0-10) received oral OROS-hydromorphone for three months. Under this treatment pain relief as well as the impact of pain on activities of daily living improved significantly. At the last examination, the patients reported a mean pain reduction of 2.5 (rest)/3.0 (movement) by day and of 2.6 (rest)/3.1 (movement) bynight (p < 0.0001). The very good pain control was accompanied by a high treatment satisfaction and an improved sleep quality. Physical therapy capability improved in 77.9% of the patients, the WOMAC index as indicator of pain and function in osteoarthritis decreased significantly from 13.3 (baseline) to 7.5 (V6). The most frequently reported adverse events were obstipation, nausea, dizziness and fatigue. 17.5% of the patients cut the study short because of adverse events.
The treatment of patients with chronic pain due to osteoarthritis with oral osmotic hydromorphone resulted in a significant reduction of all documented pain related assessments.