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Completed

NCT Number: NCT01236521

Care Management for the Effective Use of Opioids

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacological (MED)

Drug

During the baseline assessment, the nurse care managers will determine current and past treatments for chronic lower back pain and establish whether or not patients have had an adequate trial (i.e., were analgesics sufficiently dosed). If not, the nurse care manager in conjunction with study doctors will recommend an adjustment of the patients' opioid or initiate treatment with a co-analgesic with appropriate dosing and scheduling.

The Patients in the MED arm will be asked to sign an opioid treatment agreement at enrollment.

Other names: Co-analgesic algorithm

Behavioral treatment (CBT)

Behavioral

There will be 8 sessions of pain self-management and coping skills.

Other names: Pain self-management/coping skills treatment

Primary outcomes

  1. Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months

    Time frame: Baseline and 3, 6, 9, and 12 months

    The Brief Pain Inventory Total Score combines scores from the BPI Pain Intensity subscale and the BPI Pain Interference subscale. This scale provides a total score from 0 (no pain/no pain interference) to 10 (worst pain imaginable/completely interferes). We report below the baseline score on the 0 to 10 scale. At each follow-up time point (3, 6, 9, and 12 months) we report the change from baseline to follow-up. This value was calculated as the baseline score minus the follow-up score.

  2. Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point

    Time frame: Baseline and 3, 6, 9, and 12 months

    The Brief Pain Inventory pain intensity score is scored from 0 (no pain) to 10 (worst pain imaginable). We report below the baseline score on the 0 to 10 scale. At each follow-up time point (3, 6, 9, and 12 months) we report the change from baseline to follow-up. This value was calculated as the baseline score minus the follow-up score.

  3. Brief Pain Inventory Pain Interference Scale Score

    Time frame: Baseline and 3, 6, 9, and 12 months

    The Brief Pain Inventory Pain Interference Scale score assesses if pain interferes with 7 common activities. This scale is score 0 (no interference) to 10 (high interference). The 7-items are averaged to give a score.

Secondary outcomes

  1. Pain Catastrophizing Scale

    Time frame: Baseline, 6 months, and 12 months

    The Pain Catastrophizing Scale a 13-item scale that assesses catastrophizing - a pain belief that have been found to be strong predictor of poor treatment response. It is scored from 0 (no catastrophizing) to 52 (severe catastrophizing)

  2. Roland Morris Disability Scale

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months

    The Roland Morris Disability Scale is a 24-item pain-specific measure of physical disability. It provides a score from 0 (no disability) to 24 (high disability)

  3. Patient Health Questionnaire-9

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months

    The Patient Health Questionnaire-9 is used to assess depression severity. It's 9-items that are scored from 0 (no depression) to 27 (severe depression)

  4. Generalized Anxiety Disorder 7-item (GAD-7) Scale

    Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months

    The GAD-7 is a measure of anxiety. The GAD-7 consists of 7 items that are scored from 0 (no anxiety) to 21 (severe anxiety)

  5. AUDIT-C

    Time frame: Baseline, 6 months, and 12 months

    The AUDIT-C is validated as an effective screening test and diagnostic tool for alcohol misuse in primary care samples. It is scored on 0 to 10 score with higher scores representing alcohol misuse

  6. Current Opioid Misuse Measure (COMM)

    Time frame: Baseline, 6 months, and 12 months

    The COMM (Current Opioid Misuse Measure) is a 17-item instrument designed to monitor misuse and aberrant behaviors in patients prescribed opioids. The scale is scored from 0 (no evidence of opioid misuse or aberrant behaviors) to 64 (strong evidence for opioid misuse and aberrant behaviors)

  7. SF-36 General Health Perception

    Time frame: Baseline, 6 months, and 12 months

    The SF-36 is a subscale that assesses the self-reported general health. It is scored on a 0 to 100 scale with higher scores representing greater perceived general health

  8. SF-36 Vitality Scale

    Time frame: Baseline, 6 months, and 12 months

    The SF-36 vital score is a subscale that assesses participants' vitality/energy. It is scored on a 0 to 100 scale with higher scores representing greater vitality/energy.

  9. SF-36 Social Functioning Scale

    Time frame: Baseline, 6 months, and 12 months

    The SF-36 social functioning scale is a subscale that assesses the self-reported social functioning. It is scored on a 0 to 100 scale with higher scores representing better social functioning.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Care Management for the Effective Use of Opioids (CAMEO)

Acronym: CAMEO

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 8, 2010
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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