Low Back Pain, Pain
Conditions
Keywords
Back pain, Care Management, Pain, Patient outcomes, Patient-center Care, Primary care
Brief 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.
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 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
Interventions
DRUGPharmacological (MED)
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.
BEHAVIORALBehavioral treatment (CBT)
There will be 8 sessions of pain self-management and coping skills.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder 7-item (GAD-7) Scale | 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) |
| AUDIT-C | 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 |
| Current Opioid Misuse Measure (COMM) | 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) |
| Pain Catastrophizing Scale | 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) |
| SF-36 Vitality Scale | 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. |
| SF-36 Social Functioning Scale | 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. |
| SF-36 General Health Perception | 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 |
| Roland Morris Disability Scale | 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) |
| Patient Health Questionnaire-9 | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Pharmacological (PHARM) Subjects in the Pharmacological (PHARM) arm will receive at least 8 contacts with the nurse care managers (NCM) over the trial period. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment will be assessed. 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. | 131 |
| Arm 2: Behavioral Treatment (BEH) Veterans randomized to behavioral treatment arm (BEH) will receive a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists. | 130 |
| Total | 261 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Lost to Follow-up | 9 | 7 |
| Overall Study | Withdrawal by Subject | 12 | 17 |
Baseline characteristics
| Characteristic | Arm 2: Behavioral Treatment (BEH) | Total | Arm 1: Pharmacological (PHARM) |
|---|---|---|---|
| Age, Continuous | 58.2 years STANDARD_DEVIATION 9.2 | 57.9 years STANDARD_DEVIATION 9.5 | 57.6 years STANDARD_DEVIATION 9.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 54 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) White | 100 Participants | 191 Participants | 91 Participants |
| Sex: Female, Male Female | 13 Participants | 20 Participants | 7 Participants |
| Sex: Female, Male Male | 117 Participants | 241 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 131 | 1 / 130 |
| other Total, other adverse events | 10 / 131 | 2 / 130 |
| serious Total, serious adverse events | 6 / 131 | 1 / 130 |
Outcome results
Primary
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.
Time frame: Baseline and 3, 6, 9, and 12 months
Population: We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point | 3 months | 5.96 units on a scale | Standard Deviation 1.86 |
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point | 9 months | 5.84 units on a scale | Standard Deviation 1.83 |
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point | 6 months | 5.94 units on a scale | Standard Deviation 1.95 |
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point | 12 months | 5.76 units on a scale | Standard Deviation 2.14 |
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point | Baseline | 6.78 units on a scale | Standard Deviation 1.65 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point | 12 months | 6.36 units on a scale | Standard Deviation 1.59 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point | Baseline | 6.76 units on a scale | Standard Deviation 1.47 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point | 3 months | 6.24 units on a scale | Standard Deviation 1.56 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point | 6 months | 6.45 units on a scale | Standard Deviation 1.6 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point | 9 months | 6.18 units on a scale | Standard Deviation 1.69 |
p-value: 0.0067Mixed Models Analysis
Primary
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.
Time frame: Baseline and 3, 6, 9, and 12 months
Population: We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Pain Interference Scale Score | 3 months | 5.19 scores on a scale | Standard Deviation 2.38 |
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Pain Interference Scale Score | 9 months | 5.08 scores on a scale | Standard Deviation 2.57 |
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Pain Interference Scale Score | Baseline | 6.34 scores on a scale | Standard Deviation 2.07 |
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Pain Interference Scale Score | 12 months | 5.15 scores on a scale | Standard Deviation 2.46 |
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Pain Interference Scale Score | 6 months | 5.17 scores on a scale | Standard Deviation 2.51 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Pain Interference Scale Score | 12 months | 5.68 scores on a scale | Standard Deviation 2.3 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Pain Interference Scale Score | 3 months | 5.71 scores on a scale | Standard Deviation 2.28 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Pain Interference Scale Score | 6 months | 5.61 scores on a scale | Standard Deviation 2.15 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Pain Interference Scale Score | 9 months | 5.47 scores on a scale | Standard Deviation 2.19 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Pain Interference Scale Score | Baseline | 6.39 scores on a scale | Standard Deviation 1.99 |
p-value: 0.074Mixed Models Analysis
Primary
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.
Time frame: Baseline and 3, 6, 9, and 12 months
Population: We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months | 12 months | 5.31 units on a scale | Standard Deviation 2.27 |
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months | 6 months | 5.39 units on a scale | Standard Deviation 2.21 |
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months | Baseline | 6.45 units on a scale | Standard Deviation 1.79 |
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months | 9 months | 5.29 units on a scale | Standard Deviation 2.25 |
| Arm 1: Pharmacological (PHARM) | Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months | 3 months | 5.41 units on a scale | Standard Deviation 2.1 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months | 12 months | 5.85 units on a scale | Standard Deviation 1.98 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months | 3 months | 5.86 units on a scale | Standard Deviation 1.91 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months | 9 months | 5.66 units on a scale | Standard Deviation 1.91 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months | Baseline | 6.49 units on a scale | Standard Deviation 1.67 |
| Arm 2: Behavioral Treatment (BEH) | Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months | 6 months | 5.85 units on a scale | Standard Deviation 1.84 |
p-value: 0.0385Mixed Models Analysis
Secondary
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
Time frame: Baseline, 6 months, and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Pharmacological (PHARM) | AUDIT-C | Baseline | 5.65 scores on a scale | Standard Deviation 5.51 |
| Arm 1: Pharmacological (PHARM) | AUDIT-C | 6 months | 5.42 scores on a scale | Standard Deviation 5.69 |
| Arm 1: Pharmacological (PHARM) | AUDIT-C | 12 months | 5.06 scores on a scale | Standard Deviation 5.58 |
| Arm 2: Behavioral Treatment (BEH) | AUDIT-C | 12 months | 5.36 scores on a scale | Standard Deviation 5.66 |
| Arm 2: Behavioral Treatment (BEH) | AUDIT-C | Baseline | 5.87 scores on a scale | Standard Deviation 5.71 |
| Arm 2: Behavioral Treatment (BEH) | AUDIT-C | 6 months | 5.75 scores on a scale | Standard Deviation 5.4 |
Secondary
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)
Time frame: Baseline, 6 months, and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Pharmacological (PHARM) | Current Opioid Misuse Measure (COMM) | Baseline | 8.73 scores on a scale | Standard Deviation 6.81 |
| Arm 1: Pharmacological (PHARM) | Current Opioid Misuse Measure (COMM) | 6 months | 7.29 scores on a scale | Standard Deviation 6.96 |
| Arm 1: Pharmacological (PHARM) | Current Opioid Misuse Measure (COMM) | 12 months | 7.60 scores on a scale | Standard Deviation 6.96 |
| Arm 2: Behavioral Treatment (BEH) | Current Opioid Misuse Measure (COMM) | Baseline | 8.87 scores on a scale | Standard Deviation 6.54 |
| Arm 2: Behavioral Treatment (BEH) | Current Opioid Misuse Measure (COMM) | 6 months | 8.20 scores on a scale | Standard Deviation 6.85 |
| Arm 2: Behavioral Treatment (BEH) | Current Opioid Misuse Measure (COMM) | 12 months | 8.96 scores on a scale | Standard Deviation 7.94 |
Secondary
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)
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Pharmacological (PHARM) | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 3 months | 6.65 scores on a scale | Standard Deviation 4.5 |
| Arm 1: Pharmacological (PHARM) | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 9 months | 6.30 scores on a scale | Standard Deviation 4.92 |
| Arm 1: Pharmacological (PHARM) | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 6 months | 6.00 scores on a scale | Standard Deviation 5.23 |
| Arm 1: Pharmacological (PHARM) | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 12 months | 6.41 scores on a scale | Standard Deviation 5.3 |
| Arm 1: Pharmacological (PHARM) | Generalized Anxiety Disorder 7-item (GAD-7) Scale | Baseline | 6.68 scores on a scale | Standard Deviation 5.13 |
| Arm 2: Behavioral Treatment (BEH) | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 12 months | 7.02 scores on a scale | Standard Deviation 4.98 |
| Arm 2: Behavioral Treatment (BEH) | Generalized Anxiety Disorder 7-item (GAD-7) Scale | Baseline | 6.81 scores on a scale | Standard Deviation 4.63 |
| Arm 2: Behavioral Treatment (BEH) | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 3 months | 6.08 scores on a scale | Standard Deviation 4.57 |
| Arm 2: Behavioral Treatment (BEH) | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 6 months | 6.22 scores on a scale | Standard Deviation 4.88 |
| Arm 2: Behavioral Treatment (BEH) | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 9 months | 5.92 scores on a scale | Standard Deviation 4.83 |
Secondary
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)
Time frame: Baseline, 6 months, and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Pharmacological (PHARM) | Pain Catastrophizing Scale | Baseline | 23.95 scores on a scale | Standard Deviation 12.77 |
| Arm 1: Pharmacological (PHARM) | Pain Catastrophizing Scale | 6 months | 21.64 scores on a scale | Standard Deviation 13.2 |
| Arm 1: Pharmacological (PHARM) | Pain Catastrophizing Scale | 12 months | 22.14 scores on a scale | Standard Deviation 13.84 |
| Arm 2: Behavioral Treatment (BEH) | Pain Catastrophizing Scale | 6 months | 20.41 scores on a scale | Standard Deviation 12.54 |
| Arm 2: Behavioral Treatment (BEH) | Pain Catastrophizing Scale | Baseline | 24.44 scores on a scale | Standard Deviation 11.27 |
| Arm 2: Behavioral Treatment (BEH) | Pain Catastrophizing Scale | 12 months | 20.43 scores on a scale | Standard Deviation 12.04 |
Secondary
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)
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Pharmacological (PHARM) | Patient Health Questionnaire-9 | 3 months | 9.74 scores on a scale | Standard Deviation 6.33 |
| Arm 1: Pharmacological (PHARM) | Patient Health Questionnaire-9 | 9 months | 9.67 scores on a scale | Standard Deviation 6.41 |
| Arm 1: Pharmacological (PHARM) | Patient Health Questionnaire-9 | 6 months | 9.74 scores on a scale | Standard Deviation 6.56 |
| Arm 1: Pharmacological (PHARM) | Patient Health Questionnaire-9 | 12 months | 10.13 scores on a scale | Standard Deviation 6.95 |
| Arm 1: Pharmacological (PHARM) | Patient Health Questionnaire-9 | Baseline | 11.18 scores on a scale | Standard Deviation 6.4 |
| Arm 2: Behavioral Treatment (BEH) | Patient Health Questionnaire-9 | 12 months | 10.53 scores on a scale | Standard Deviation 6.21 |
| Arm 2: Behavioral Treatment (BEH) | Patient Health Questionnaire-9 | Baseline | 11.19 scores on a scale | Standard Deviation 5.82 |
| Arm 2: Behavioral Treatment (BEH) | Patient Health Questionnaire-9 | 3 months | 9.94 scores on a scale | Standard Deviation 6.14 |
| Arm 2: Behavioral Treatment (BEH) | Patient Health Questionnaire-9 | 6 months | 10.04 scores on a scale | Standard Deviation 6.12 |
| Arm 2: Behavioral Treatment (BEH) | Patient Health Questionnaire-9 | 9 months | 9.84 scores on a scale | Standard Deviation 5.68 |
Secondary
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)
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Pharmacological (PHARM) | Roland Morris Disability Scale | 3 months | 15.55 scores on a scale | Standard Deviation 5.18 |
| Arm 1: Pharmacological (PHARM) | Roland Morris Disability Scale | 6 months | 15.32 scores on a scale | Standard Deviation 5.2 |
| Arm 1: Pharmacological (PHARM) | Roland Morris Disability Scale | 9 months | 15.54 scores on a scale | Standard Deviation 5.53 |
| Arm 1: Pharmacological (PHARM) | Roland Morris Disability Scale | Baseline | 16.59 scores on a scale | Standard Deviation 4.7 |
| Arm 1: Pharmacological (PHARM) | Roland Morris Disability Scale | 12 months | 15.60 scores on a scale | Standard Deviation 5.85 |
| Arm 2: Behavioral Treatment (BEH) | Roland Morris Disability Scale | 12 months | 16.58 scores on a scale | Standard Deviation 5.34 |
| Arm 2: Behavioral Treatment (BEH) | Roland Morris Disability Scale | 3 months | 15.80 scores on a scale | Standard Deviation 5.2 |
| Arm 2: Behavioral Treatment (BEH) | Roland Morris Disability Scale | Baseline | 16.72 scores on a scale | Standard Deviation 4.15 |
| Arm 2: Behavioral Treatment (BEH) | Roland Morris Disability Scale | 6 months | 15.34 scores on a scale | Standard Deviation 5.5 |
| Arm 2: Behavioral Treatment (BEH) | Roland Morris Disability Scale | 9 months | 15.33 scores on a scale | Standard Deviation 5.5 |
Secondary
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
Time frame: Baseline, 6 months, and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Pharmacological (PHARM) | SF-36 General Health Perception | Baseline | 43.66 scores on a scale | Standard Deviation 20.92 |
| Arm 1: Pharmacological (PHARM) | SF-36 General Health Perception | 6 months | 45.85 scores on a scale | Standard Deviation 19.89 |
| Arm 1: Pharmacological (PHARM) | SF-36 General Health Perception | 12 months | 42.70 scores on a scale | Standard Deviation 23.03 |
| Arm 2: Behavioral Treatment (BEH) | SF-36 General Health Perception | Baseline | 45.39 scores on a scale | Standard Deviation 18.64 |
| Arm 2: Behavioral Treatment (BEH) | SF-36 General Health Perception | 6 months | 45.83 scores on a scale | Standard Deviation 20.4 |
| Arm 2: Behavioral Treatment (BEH) | SF-36 General Health Perception | 12 months | 42.44 scores on a scale | Standard Deviation 20.17 |
Secondary
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.
Time frame: Baseline, 6 months, and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Pharmacological (PHARM) | SF-36 Social Functioning Scale | Baseline | 48.47 scores on a scale | Standard Deviation 27.21 |
| Arm 1: Pharmacological (PHARM) | SF-36 Social Functioning Scale | 6 months | 55.79 scores on a scale | Standard Deviation 29.67 |
| Arm 1: Pharmacological (PHARM) | SF-36 Social Functioning Scale | 12 months | 55.72 scores on a scale | Standard Deviation 28.49 |
| Arm 2: Behavioral Treatment (BEH) | SF-36 Social Functioning Scale | Baseline | 49.81 scores on a scale | Standard Deviation 29.32 |
| Arm 2: Behavioral Treatment (BEH) | SF-36 Social Functioning Scale | 6 months | 51.10 scores on a scale | Standard Deviation 27.4 |
| Arm 2: Behavioral Treatment (BEH) | SF-36 Social Functioning Scale | 12 months | 52.02 scores on a scale | Standard Deviation 28.12 |
Secondary
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.
Time frame: Baseline, 6 months, and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Pharmacological (PHARM) | SF-36 Vitality Scale | Baseline | 38.64 scores on a scale | Standard Deviation 16.98 |
| Arm 1: Pharmacological (PHARM) | SF-36 Vitality Scale | 6 months | 40.00 scores on a scale | Standard Deviation 17.5 |
| Arm 1: Pharmacological (PHARM) | SF-36 Vitality Scale | 12 months | 40.51 scores on a scale | Standard Deviation 16.28 |
| Arm 2: Behavioral Treatment (BEH) | SF-36 Vitality Scale | Baseline | 35.08 scores on a scale | Standard Deviation 16.17 |
| Arm 2: Behavioral Treatment (BEH) | SF-36 Vitality Scale | 6 months | 38.33 scores on a scale | Standard Deviation 17.06 |
| Arm 2: Behavioral Treatment (BEH) | SF-36 Vitality Scale | 12 months | 38.19 scores on a scale | Standard Deviation 15.74 |