Opioid therapy for chronic noncancer back pain - A randomized prospective study

Study Design. A randomized, open, long-term, repeated-dose comparison of an anti-inflammatory drug and two opioid regimens in 36 patients with back pa in. Objectives. To examine the long-term safety and efficacy of chronic opioid therapy in a randomized trial of patients with back pain. Methods. All participants underwent a 4-week washout period of no opioid me dication before being randomly assigned to one of three treatment regimens for 16 weeks: 1) naproxen only, 2) set-dose oxycodone, or 3) titrated-dose oxycodone and sustained-release morphine sulfate. All patients then were as signed to a titrated dose of opioids for 16 weeks and then gradually tapere d off their medication for 12 weeks. Finally, all participants were monitor ed for a 1-month posttreatment washout period. Each patient was called once a week for a report on pain, activity, mood, medication, hours awake, and adverse effects and as monitored carefully for signs of abuse and noncompli ance. Results. Weekly reports during the experimental phase showed the titrated-d ose group to have less pain (P < 0.001) and less emotional distress (P < 0. 001) than the other two groups. Both opioid groups were significantly diffe rent from the naproxen-only group. During the titration phase, patients als o reported significantly less pain and improved mood. Few differences were found in activity or hours asleep, or between average pretreatment and post -treatment phone-interview and questionnaire variables. No adverse events o ccurred, and only one participant showed signs of abuse behavior. Conclusions. The results suggest that opioid therapy has a positive effect on pain and mood but little effect on activity and sleep. Opioid therapy fo r chronic back pain was used without significant risk of abuse. However, ta pered-off opioid treatment is palliative and without long-term benefit.