Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms

Depression Clinical Trial

Official title: Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms

Status Completed

Clinical Trial Summary

Opioids are frequently prescribed for chronic low back pain (CLBP). Psychiatric illness, such as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic pain patients (and is termed comorbid negative affect [NA]). The purpose of the study is to determine whether CLBP patients with either a high vs. a low or moderate degree of NA have different pain relief responses to oral opioids.

Clinical Trial Description

The level of high, moderate or low NA was determined based on the participant's score on the Hospital Anxiety and Depression Scale (HADS). The HADS is a self-reported questionnaire that has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each item on the questionnaire is scored from 0 (least amount of anxiety/depression) to 3 (greatest amount of anxiety/depression), with total score between 0 and 21 for either anxiety or depression. Participants were assigned to high, moderate or low NA groups using the following HADS score criteria:

• High NA = HADS score ≥9 on each subscale

• Moderate NA = HADS score ≥6 to ≤8 on each subscale

• Low NA = HADS score ≤5 on each subscale ;

Related Conditions & MeSH terms

• Anxiety
• Back Pain
• Chronic Low Back Pain
• Degenerative Disc Disease
• Depression
• Intervertebral Disc Degeneration
• Low Back Pain

• NCT number: NCT01502644
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Status: Completed
• Phase: Phase 4
• Start date: February 2009
• Completion date: January 2013