Low Back PainCAMEONCT01236521
Care Management for the Effective Use of Opioids
A study testing Pharmacological (MED) and Behavioral treatment (CBT) in people with Low Back Pain and Pain, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Pain
- What is being tested?
- Pharmacological (MED) and Behavioral treatment (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2011to 31 Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe medical conditions
- active psychosis
- schizophrenia
- active suicidal ideation
- pending back surgery
- moderately severe cognitive impairment
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
About this study
Official title: Care Management for the Effective Use of Opioids (CAMEO)
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.
Read the detailed 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
- 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
- Conditions
- Low Back Pain, Pain
- Being tested
- Pharmacological (MED), Behavioral treatment (CBT)
- Keywords
- Back pain, Care Management, Pain, Patient outcomes, Patient-center Care, Primary care
- Medical subject headings
- Low Back Pain, Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacological (MED)Drug
Also called Co-analgesic algorithm
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.
Behavioral treatment (CBT)Behavioural
Also called Pain self-management/coping skills treatment
There will be 8 sessions of pain self-management and coping skills.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Pharmacological (MED) | Experimental | Subjects in the Pharmacological (MED) arm will receive at least 8 contacts with the nurse care managers (NCM) over the trial period. Participants will have an initial visit at baseline to assess their current and past treatments for chronic lower back pain, pain intensity, and pain-related limitations. Patients' opioids will be adjusted and/or co-analgesics (or adjuvants) will be initiated. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment will be assessed. Follow-up NCM telephone contacts will occur at 2 and 4 weeks after baseline, and months 2, 3, 4, 6, and 9 months. On average, these calls last between 10 to 20 minutes. Detailed logs will be kept of the timing and content of patient contacts. Receives: Drug: Pharmacological (MED) |
| Arm 2: Behavioral treatment (CBT) | Experimental | Veterans randomized to behavioral treatment arm (CBT) will receive a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists. Since optimal application of non-pharmacological interventions for pain involves tailoring to patient needs, participants will be introduced to a menu of self-management and coping skills rather than receive a prescribed program. Delivery of the behavioral intervention will employ a flexible approach that is easily adapted to individual preferences and perceived need for learning specific pain coping skills. Tailoring will include the selection of relevant content and skills and assessment of readiness to change behaviors. Receives: Behavioral: Behavioral treatment (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 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.
Measured: Baseline and 3, 6, 9, and 12 months
Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point
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.
Measured: Baseline and 3, 6, 9, and 12 months
Brief Pain Inventory Pain Interference Scale Score
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.
Measured: Baseline and 3, 6, 9, and 12 months
Secondary outcomes (9)
Pain Catastrophizing Scale
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)
Measured: Baseline, 6 months, and 12 months
Roland Morris Disability Scale
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)
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months
Patient Health Questionnaire-9
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)
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months
Generalized Anxiety Disorder 7-item (GAD-7) Scale
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)
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months
AUDIT-C
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
Measured: Baseline, 6 months, and 12 months
Current Opioid Misuse Measure (COMM)
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)
Measured: Baseline, 6 months, and 12 months
SF-36 General Health Perception
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
Measured: Baseline, 6 months, and 12 months
SF-36 Vitality Scale
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.
Measured: Baseline, 6 months, and 12 months
SF-36 Social Functioning Scale
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.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study start1 Dec 2011
- Primary completion11 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew J. Bair, MD MS, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236521
- Sponsor's protocol ID
- IIR 10-128
- Acronym
- CAMEO
- Status last verified
- Jul 2023
- First submitted
- 5 Nov 2010
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon request, we will share data with other researchers
Publications
Chen CX, Kroenke K, Stump TE, Kean J, Carpenter JS, Krebs EE, Bair MJ, Damush TM, Monahan PO. Estimating minimally important differences for the PROMIS pain interference scales: results from 3 randomized clinical trials. Pain. 2018 Apr;159(4):775-782. doi: 10.1097/j.pain.0000000000001121.
PubMed 29200181Chen CX, Kroenke K, Stump T, Kean J, Krebs EE, Bair MJ, Damush T, Monahan PO. Comparative Responsiveness of the PROMIS Pain Interference Short Forms With Legacy Pain Measures: Results From Three Randomized Clinical Trials. J Pain. 2019 Jun;20(6):664-675. doi: 10.1016/j.jpain.2018.11.010. Epub 2018 Dec 6.
PubMed 30529442Bair MJ, Outcalt SD, Slaven JE, Kroenke K, Kempf C, Zillich AJ, Damush TM, Saha C, French DD, Krebs EE. Care Management for the Effective Use of Opioids (CAMEO): A Randomized Trial. Abstracts of the 77th Annual Scientific Meeting, March 6-9, 2019. Vancouver, BC, Canada. Abstract 1734. [Abstract]. Psychosomatic medicine. 2019 May 1; 81(4):A-149.
Kroenke K, Stump TE, Chen CX, Kean J, Bair MJ, Damush TM, Krebs EE, Monahan PO. Minimally important differences and severity thresholds are estimated for the PROMIS depression scales from three randomized clinical trials. J Affect Disord. 2020 Apr 1;266:100-108. doi: 10.1016/j.jad.2020.01.101. Epub 2020 Jan 23.
PubMed 32056864Kroenke K, Stump TE, Chen CX, Kean J, Damush TM, Bair MJ, Krebs EE, Monahan PO. Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials. Health Qual Life Outcomes. 2021 Feb 4;19(1):41. doi: 10.1186/s12955-021-01674-3.
PubMed 33541362Kroenke K, Stump TE, Kean J, Krebs EE, Damush TM, Bair MJ, Monahan PO. Diagnostic operating characteristics of PROMIS scales in screening for depression. J Psychosom Res. 2021 Aug;147:110532. doi: 10.1016/j.jpsychores.2021.110532. Epub 2021 May 25.
PubMed 34052655Bushey MA, Slaven J, Outcalt SD, Kroenke K, Kempf C, Froman A, Sargent C, Baecher B, Zillich A, Damush TM, Saha C, French DD, Bair MJ. Design and methods of the Care Management for the Effective Use of Opioids (CAMEO) trial. Contemp Clin Trials. 2021 Jul;106:106456. doi: 10.1016/j.cct.2021.106456. Epub 2021 May 25.
PubMed 34048943Bushey MA, Slaven JE, Outcalt SD, Kroenke K, Kempf C, Froman A, Sargent C, Baecher B, Zillich AJ, Damush TM, Saha C, French DD, Bair MJ. Effect of Medication Optimization vs Cognitive Behavioral Therapy Among US Veterans With Chronic Low Back Pain Receiving Long-term Opioid Therapy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2242533. doi: 10.1001/jamanetworkopen.2022.42533.
PubMed 36394874Midboe AM, Lewis ET, Paik MC, Gallagher RM, Rosenberg JM, Goodman F, Kerns RD, Becker WC, Trafton JA. Measurement of adherence to clinical practice guidelines for opioid therapy for chronic pain. Transl Behav Med. 2012 Mar;2(1):57-64. doi: 10.1007/s13142-011-0104-5.
PubMed 24073098Koechlin H, Locher C, Barke A, Korwisi B. Retrospective identification of the diagnosis of chronic primary musculoskeletal pain: a pragmatic suggestion by The Pain Net. Pain. 2025 Feb 1;166(2):311-314. doi: 10.1097/j.pain.0000000000003380. Epub 2024 Sep 3. No abstract available.
PubMed 39172815
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Management for the Effective Use of Opioids (CAMEO)
- ClinicalTrials.gov ID
- NCT01236521
- Acronym / sponsor ID
- CAMEO / IIR 10-128
- Conditions
- Low Back Pain, Pain
- Keywords
- Back pain, Care Management, Pain, Patient outcomes, Patient-center Care, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 11 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Posted 8 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Pharmacological (MED) | Experimental | Drug: Pharmacological (MED)Subjects in the Pharmacological (MED) arm will receive at least 8 contacts with the nurse care managers (NCM) over the trial period. Participants will have an initial visit at baseline to assess their current and past treatments for chronic lower back pain, pain intensity, and pain-related limitations. Patients' opioids will be adjusted and/or co-analgesics (or adjuvants) will be initiated. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment will be assessed. Follow-up NCM telephone contacts will occur at 2 and 4 weeks after baseline, and months 2, 3, 4, 6, and 9 months. On average, these calls last between 10 to 20 minutes. Detailed logs will be kept of the timing and content of patient contacts. |
| Arm 2: Behavioral treatment (CBT) | Experimental | Behavioral: Behavioral treatment (CBT)Veterans randomized to behavioral treatment arm (CBT) will receive a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists. Since optimal application of non-pharmacological interventions for pain involves tailoring to patient needs, participants will be introduced to a menu of self-management and coping skills rather than receive a prescribed program. Delivery of the behavioral intervention will employ a flexible approach that is easily adapted to individual preferences and perceived need for learning specific pain coping skills. Tailoring will include the selection of relevant content and skills and assessment of readiness to change behaviors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- chronic lower back pain of at least moderate intensity
- pain for 6 months
- on chronic opioid therapy
- and access to a working telephone
Key exclusion criteria (9 listed)
- severe medical conditions
- active psychosis
- schizophrenia
- active suicidal ideation
- pending back surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacological (MED)Also: Co-analgesic algorithmDuring 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. | Drug | Arm 1: Pharmacological (MED) |
| Behavioral treatment (CBT)Also: Pain self-management/coping skills treatmentThere will be 8 sessions of pain self-management and coping skills. | Behavioural | Arm 2: Behavioral treatment (CBT) |
Primary outcome
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.
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.
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.
9 secondary outcomes
Pain Catastrophizing Scale
Time frame: Baseline, 6 months, and 12 months
Roland Morris Disability Scale
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Patient Health Questionnaire-9
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
AUDIT-C
Time frame: Baseline, 6 months, and 12 months
Current Opioid Misuse Measure (COMM)
Time frame: Baseline, 6 months, and 12 months
SF-36 General Health Perception
Time frame: Baseline, 6 months, and 12 months
SF-36 Vitality Scale
Time frame: Baseline, 6 months, and 12 months
SF-36 Social Functioning Scale
Time frame: Baseline, 6 months, and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29200181Chen CX, Kroenke K, Stump TE, Kean J, Carpenter JS, Krebs EE, Bair MJ, Damush TM, Monahan PO. Estimating minimally important differences for the PROMIS pain interference scales: results from 3 randomized clinical trials. Pain. 2018 Apr;159(4):775-782. doi: 10.1097/j.pain.0000000000001121.
- Results publication: PubMed 30529442Chen CX, Kroenke K, Stump T, Kean J, Krebs EE, Bair MJ, Damush T, Monahan PO. Comparative Responsiveness of the PROMIS Pain Interference Short Forms With Legacy Pain Measures: Results From Three Randomized Clinical Trials. J Pain. 2019 Jun;20(6):664-675. doi: 10.1016/j.jpain.2018.11.010. Epub 2018 Dec 6.
- Results publicationBair MJ, Outcalt SD, Slaven JE, Kroenke K, Kempf C, Zillich AJ, Damush TM, Saha C, French DD, Krebs EE. Care Management for the Effective Use of Opioids (CAMEO): A Randomized Trial. Abstracts of the 77th Annual Scientific Meeting, March 6-9, 2019. Vancouver, BC, Canada. Abstract 1734. [Abstract]. Psychosomatic medicine. 2019 May 1; 81(4):A-149.
- Results publication: PubMed 32056864Kroenke K, Stump TE, Chen CX, Kean J, Bair MJ, Damush TM, Krebs EE, Monahan PO. Minimally important differences and severity thresholds are estimated for the PROMIS depression scales from three randomized clinical trials. J Affect Disord. 2020 Apr 1;266:100-108. doi: 10.1016/j.jad.2020.01.101. Epub 2020 Jan 23.
- Results publication: PubMed 33541362Kroenke K, Stump TE, Chen CX, Kean J, Damush TM, Bair MJ, Krebs EE, Monahan PO. Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials. Health Qual Life Outcomes. 2021 Feb 4;19(1):41. doi: 10.1186/s12955-021-01674-3.
- Results publication: PubMed 34052655Kroenke K, Stump TE, Kean J, Krebs EE, Damush TM, Bair MJ, Monahan PO. Diagnostic operating characteristics of PROMIS scales in screening for depression. J Psychosom Res. 2021 Aug;147:110532. doi: 10.1016/j.jpsychores.2021.110532. Epub 2021 May 25.
- Results publication: PubMed 34048943Bushey MA, Slaven J, Outcalt SD, Kroenke K, Kempf C, Froman A, Sargent C, Baecher B, Zillich A, Damush TM, Saha C, French DD, Bair MJ. Design and methods of the Care Management for the Effective Use of Opioids (CAMEO) trial. Contemp Clin Trials. 2021 Jul;106:106456. doi: 10.1016/j.cct.2021.106456. Epub 2021 May 25.
- Results publication: PubMed 36394874Bushey MA, Slaven JE, Outcalt SD, Kroenke K, Kempf C, Froman A, Sargent C, Baecher B, Zillich AJ, Damush TM, Saha C, French DD, Bair MJ. Effect of Medication Optimization vs Cognitive Behavioral Therapy Among US Veterans With Chronic Low Back Pain Receiving Long-term Opioid Therapy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2242533. doi: 10.1001/jamanetworkopen.2022.42533.
- Results publication: PubMed 24073098Midboe AM, Lewis ET, Paik MC, Gallagher RM, Rosenberg JM, Goodman F, Kerns RD, Becker WC, Trafton JA. Measurement of adherence to clinical practice guidelines for opioid therapy for chronic pain. Transl Behav Med. 2012 Mar;2(1):57-64. doi: 10.1007/s13142-011-0104-5.
- Derived from this study: PubMed 39172815Koechlin H, Locher C, Barke A, Korwisi B. Retrospective identification of the diagnosis of chronic primary musculoskeletal pain: a pragmatic suggestion by The Pain Net. Pain. 2025 Feb 1;166(2):311-314. doi: 10.1097/j.pain.0000000000003380. Epub 2024 Sep 3. No abstract available.
- Individual participant dataSharing planned: No. Upon request, we will share data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J. Bair, MD MS principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacological (MED) and Behavioral treatment (CBT) in people with Low Back Pain and Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01236521, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.