Abstract
Objectives: Patients with chronic noncancer pain frequently report symptoms of depression and anxiety (negative affect), which are associated with higher ratings of pain intensity and a greater likelihood of being prescribed chronic opioid therapy. The purpose of this secondary analysis was to test the hypothesis that initial levels of negative affect can predict treatment-related outcomes in a double-blind, placebo-controlled study of extended-release (ER) hydromorphone among opioid-tolerant patients with chronic low back pain. Methods: Four hundred fifty-nine (N=459) patients participated in the titration/conversion phase of a multicenter study, of which 268 were randomized to receive once-daily hydromorphone or placebo. All patients completed the Hospital Anxiety and Depression Scale (HADS) at baseline and were divided evenly into Low (N=157), Moderate (N=155), and High (N=147) negative affect groups based on their scores. Group differences in numerical pain intensity measures at home and in the clinic, Roland-Morris Disability ratings, and measures of symptoms from the Subjective Opiate Withdrawal Scale (SOWS) throughout the trial were analyzed. Results: Two hundred sixty-eight of the initial 459 subjects who entered the 2 to 4-week titration/conversion phase (pretreatment) were successfully randomized to either placebo or ER hydromorphone; a total of 110 patients then completed this double-bflind phase of the study. Those in the Moderate and High negative affect groups tended to drop out more often during the titration/conversion phase because of the adverse effects or lack of efficacy of their prescribed opioid than those in the Low negative mood group (P
Original language | English (US) |
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Pages (from-to) | 173-181 |
Number of pages | 9 |
Journal | Pain Practice |
Volume | 13 |
Issue number | 3 |
DOIs | |
State | Published - Mar 2013 |
Externally published | Yes |
Keywords
- Chronic pain
- Clinical trial
- Double-blind
- Mood
- Negative affect
- Opioid tolerance
- Opioids
- Placebo-controlled
- Randomized controlled trial
- RCT
ASJC Scopus subject areas
- Anesthesiology and Pain Medicine