Care Management for the Effective Use of Opioids — CAMEO  

Pain Clinical Trial

Official title: Care Management for the Effective Use of Opioids (CAMEO)

Status Completed

Clinical Trial Summary

The CAre Management for the Effective use of Opioids (CAMEO) trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for chronic lower back pain. The study aims are to compare the interventions' (PHARM vs. BEH) effects on pain intensity, pain interference, function, and other pain relevant outcomes over 12 months.

Clinical Trial Description

The general purpose of the CAre Management for the Effective use of Opioids (CAMEO) study is to develop, test, and implement novel treatments and care delivery models that address barriers to effective pain management and that can be practicably applied in VA primary care settings for chronic low back pain (CLBP). The CAMEO trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for CLBP.

The investigators' study sample will target 272 Veterans with moderate to severe CLBP despite long-term opioid therapy. Patients from five primary care clinics at the Roudebush VA Medical Center and two community based outpatient clinics will be recruited to participate in CAMEO and randomized to one of two treatment arms. The pharmacological arm will involve guideline-concordant opioid management coupled with algorithm-based co-analgesic treatment (MED). Patients in the behavioral arm (CBT) will receive pain self-management/coping skills training. The trial will last 12-months and all participants will undergo comprehensive outcome assessments at baseline, 3, 6, 9, and 12 months.

Study Aims: Among Veterans with chronic low back pain refractory to long-term opioid therapy

1. To compare the interventions' (MED vs. CBT) effects on pain intensity and function over 12 months

2. To compare the interventions' effects (MED vs. CBT) on other relevant outcomes

• Health-related quality of life

• Pain Catastrophizing

• Depression

• Anxiety

• Disability

• Opioid misuse and opioid dose ;

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Pain

• NCT number: NCT01236521
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Completed
• Phase: N/A
• Start date: December 1, 2011
• Completion date: December 31, 2015