N/A
Completed N=261
Care Management for the Effective Use of Opioids
Source: ClinicalTrials.gov NCT01236521 ↗Enrolled (actual)
261
Serious AEs
2.7%
Results posted
Jun 2018
Primary outcomePrimary: Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months — 6.45; 6.49; 5.41; 5.86 units on a scale — p=0.0385
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months |
6.45; 6.49; 5.41; 5.86; 5.39; 5.85 | 0.0385 sig |
| PRIMARY Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point |
6.78; 6.76; 5.96; 6.24; 5.94; 6.45 | 0.0067 sig |
| PRIMARY Brief Pain Inventory Pain Interference Scale Score |
6.34; 6.39; 5.19; 5.71; 5.17; 5.61 | 0.0740 |
| SECONDARY Pain Catastrophizing Scale |
23.95; 24.44; 21.64; 20.41; 22.14; 20.43 | — |
| SECONDARY Roland Morris Disability Scale |
16.59; 16.72; 15.55; 15.80; 15.32; 15.34 | — |
| SECONDARY Patient Health Questionnaire-9 |
11.18; 11.19; 9.74; 9.94; 9.74; 10.04 | — |
| SECONDARY Generalized Anxiety Disorder 7-item (GAD-7) Scale |
6.68; 6.81; 6.65; 6.08; 6.00; 6.22 | — |
| SECONDARY AUDIT-C |
5.65; 5.87; 5.42; 5.75; 5.06; 5.36 | — |
| SECONDARY Current Opioid Misuse Measure (COMM) |
8.73; 8.87; 7.29; 8.20; 7.60; 8.96 | — |
| SECONDARY SF-36 General Health Perception |
43.66; 45.39; 45.85; 45.83; 42.70; 42.44 | — |
| SECONDARY SF-36 Vitality Scale |
38.64; 35.08; 40.00; 38.33; 40.51; 38.19 | — |
| SECONDARY SF-36 Social Functioning Scale |
48.47; 49.81; 55.79; 51.10; 55.72; 52.02 | — |
Eligibility Criteria
Inclusion Criteria
Veterans will be eligible if they have:
- chronic lower back pain of at least moderate intensity
- pain for 6 months
- on chronic opioid therapy
- and access to a working telephone
Exclusion Criteria
Exclusion criteria includes:
- severe medical conditions
- active psychosis
- schizophrenia
- active suicidal ideation
- pending back surgery
- moderately severe cognitive impairment
- involvement in ongoing pain trials
- and pregnant or trying to become pregnant
The investigators will exclude Veterans with an active substance use disorder (i.e., those currently in treatment), but to maximize generalizability the investigators will not exclude those with a past history of substance abuse.
Data sourced from ClinicalTrials.gov (NCT01236521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.