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The purpose of this study is to determine if a stepped-care intervention makes pain symptoms better and reduces activity limitations because of pain. Our two primary hypotheses are that in OIF/OEF veterans with chronic pain:
Through the Evaluation of Stepped Care for Chronic Pain (ESCAPE) trial we aim to develop and test a stepped-care intervention to improve functional and work-related outcomes in Operation Iraqi Freedom/Operation Enduring Freedom veterans with chronic musculoskeletal pain. Stepped-care involves starting with lower intensity, less costly treatments initially (Step 1) and "stepping up" to more intensive, costly, or complex treatments in patients with inadequate response (Step 2). The study design will be a randomized controlled trial. The stepped care approach will involve 12 weeks of a pain self-management program in Step 1 followed by 12 weeks of brief cognitive behavioral therapy in participants with inadequate improvement in pain-related disability (Step 2). Patients treated in usual care will be the control group. Thus, the primary objective of the ESCAPE trial is to conduct a randomized controlled trial to compare the effectiveness of a stepped care intervention vs. usual care in OIF/OEF veterans with chronic and disabling musculoskeletal pain and evaluate the impact of this intervention on pain-related disability, work function, psychological distress, and secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete. | |
| Stepped Care | Experimental | Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy | Behavioral | Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Roland-Morris Disability Questionnaire | This is a 24-item pain specific disability questionnaire consisting of 24 questions which are related specifically to physical functions that are likely to be affected by back pain. The questionnaire is scored by adding up the number of items checked by the subject (0-24 range). Greater levels of disability are reflected by higher numbers. | at baseline and 9 months |
| Brief Pain Inventory (Interference) | This is an 7-item measure that provides scores for pain-related functional impairment. The seven (7) pain interference items are rated on a simple numeric rating scale from 0-10. On the scale 0 represents "no interference" and 10 is "completely interferes". The pain interference score is achieved by taking the total of all seven (7) scores and dividing it by the number of items (7). | Baseline and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| SF-Mental Component Summary (MCS) | This scale provides a measure of mental health quality of life. It is measure on a 0 to 100 scale with higher scores representing better mental health | Baseline and 9 months |
| PHQ-9 Depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J. Bair, MD MS | Richard Roudebush VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard Roudebush VA Medical Center, Indianapolis | Indianapolis | Indiana | 46202-2884 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19470987 | Result | Kroenke K, Bair MJ, Damush TM, Wu J, Hoke S, Sutherland J, Tu W. Optimized antidepressant therapy and pain self-management in primary care patients with depression and musculoskeletal pain: a randomized controlled trial. JAMA. 2009 May 27;301(20):2099-110. doi: 10.1001/jama.2009.723. | |
| 27187854 | Derived | Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, Monahan PO. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosom Med. 2016 Jul-Aug;78(6):716-27. doi: 10.1097/PSY.0000000000000322. |
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Enrollment began December 2007 and concluded June 2011. The final assessment was completed by May 2012. All subjects were recruited from the Roudebush VA Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete. |
| FG001 | Stepped Care | Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program. Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12. Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study. Co-Analgesic Therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Roland-Morris Disability Questionnaire | This is a 24-item pain specific disability questionnaire consisting of 24 questions which are related specifically to physical functions that are likely to be affected by back pain. The questionnaire is scored by adding up the number of items checked by the subject (0-24 range). Greater levels of disability are reflected by higher numbers. | We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis | Posted | Mean | Standard Deviation | scores on a scale | at baseline and 9 months |
|
The time frame in which adverse event data were collected was from the baseline evaluation to the 9-month assessment. Therefore, the assessment period was for 9 months which was through study completion.
There were 7 Serious Adverse Events reported to the IRB according to the VA definition of a serious adverse event. VA requires reporting of any hospital stay longer than 24 hours by any subject enrolled. There were 7. The IRB did not find these to be Serious Adverse Events resulting from the study and these are called "VA Events" officially.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospital stay longer than 24 hours | Psychiatric disorders | ICD-9 | Systematic Assessment | IRB found that this event not to be a serious adverse event |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medication side effects | Nervous system disorders | ICD-9 | Non-systematic Assessment | dizziness related to study medication |
Single VA Center; May not generalize to non-VA samples
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew J. Bair, MD MS | Center on Implementing Evidence Based Practice | 317-988-2058 | mbair@iupui.edu |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D010146 | Pain |
| D010148 | Pain, Intractable |
| D000377 | Agnosia |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D009294 | Narcotics |
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|
| Pain self-management program | Behavioral | The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12. |
|
| Co-Analgesic Therapy | Drug | Amitriptyline, start at 10-25, titrate to 100 mg Nortriptyline, start at 10-25, titrate to 100 mg Gabapentin, titrate up to 900-1200 tid venlafaxine, carbemazepine, duloxetine, and/or pregabalin Cyclobenzaprine, titrate to 10 mg TID fluoxetine, sertraline, citalopram |
|
| Opioid Analgesics | Drug | Tramadol 50 mg BID or TID and titrate to 100 mg QID Acetaminophen/codeine (300mg/30mg). Take 1 or 2 tablets qid prn pain Acetaminophen/hydrocodone (500mg/5mg). Take 1 or 2 tablets qid prn pain Acetaminophen/oxycodone (500mg/5mg). Take 1 or 2 tablets qid prn pain Morphine SR (30mg). Start at 30 mg twice a day (titrate up to 240mg/day if needed) Methadone (5-10mg). Start at 5mg bid; titrate 10mg tid (max 20mg tid) |
|
This measure assesses depression symptoms on a 0 to 27 scale with higher scores representing more severe depression
| Baseline and 9 months |
| PTSD Checklist-17 Civilian Version (PCL-C) | The PCL-17 is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Two versions of the PCL exist: PCL-Military and PCL-Civilian.We used the PCL-Civilian version because it addresses the broadest range of possible events as the traumatic stressor. The PCL-C has demonstrated strong reliability and validity in multiple samples. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely". Higher scores represent more severe PTSD symptoms. | Baseline and 9 months |
| GAD-7 Anxiety Score | This 7-item scale assesses anxiety symptoms on a 0 to 21 scale with higher scores representing more severe anxiety symptoms | Baseline and 9 months |
| Pain Catastrophizing Scale (PCS) | The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0-52 with higher scores representing more pain catastrophizing. | Baseline and 9 months |
| 25751701 | Derived | Bair MJ, Ang D, Wu J, Outcalt SD, Sargent C, Kempf C, Froman A, Schmid AA, Damush TM, Yu Z, Davis LW, Kroenke K. Evaluation of Stepped Care for Chronic Pain (ESCAPE) in Veterans of the Iraq and Afghanistan Conflicts: A Randomized Clinical Trial. JAMA Intern Med. 2015 May;175(5):682-9. doi: 10.1001/jamainternmed.2015.97. |
| Stepped Care |
Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program. Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12. Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study. Co-Analgesic Therapy |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Stepped Care | Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program. Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12. Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study. Co-Analgesic Therapy |
|
|
| Primary | Brief Pain Inventory (Interference) | This is an 7-item measure that provides scores for pain-related functional impairment. The seven (7) pain interference items are rated on a simple numeric rating scale from 0-10. On the scale 0 represents "no interference" and 10 is "completely interferes". The pain interference score is achieved by taking the total of all seven (7) scores and dividing it by the number of items (7). | We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis | Posted | Mean | Standard Deviation | units on a scale | Baseline and 9 months |
|
|
|
| Secondary | SF-Mental Component Summary (MCS) | This scale provides a measure of mental health quality of life. It is measure on a 0 to 100 scale with higher scores representing better mental health | We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis | Posted | Mean | Standard Deviation | units on a scale | Baseline and 9 months |
|
|
|
| Secondary | PHQ-9 Depression | This measure assesses depression symptoms on a 0 to 27 scale with higher scores representing more severe depression | We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 9 months |
|
|
|
| Secondary | PTSD Checklist-17 Civilian Version (PCL-C) | The PCL-17 is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Two versions of the PCL exist: PCL-Military and PCL-Civilian.We used the PCL-Civilian version because it addresses the broadest range of possible events as the traumatic stressor. The PCL-C has demonstrated strong reliability and validity in multiple samples. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely". Higher scores represent more severe PTSD symptoms. | We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline and 9 months |
|
|
|
| Secondary | GAD-7 Anxiety Score | This 7-item scale assesses anxiety symptoms on a 0 to 21 scale with higher scores representing more severe anxiety symptoms | We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis | Posted | Mean | Standard Deviation | units on a scale | Baseline and 9 months |
|
|
|
| Secondary | Pain Catastrophizing Scale (PCS) | The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0-52 with higher scores representing more pain catastrophizing. | We had baseline data available for 241 participants; 120 in the usual care arm and 121 in the stepped care arm. At 9 months, 7 participants withdrew from the study leaving 114 usual care participants available for analysis. In the stepped care arm, 13 participants withdrew leaving 108 available for analysis | Posted | Mean | Standard Deviation | units on a scale | Baseline and 9 months |
|
|
|
| 1 |
| 121 |
| 0 |
| 121 |
| EG001 | Stepped Care | Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program. Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12. Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study. Co-Analgesic Therapy | 6 | 121 | 4 | 121 |
|
| hospitalization for longer than 24 hours | Nervous system disorders | ICD-9 | Systematic Assessment | IRB found these not to be serious adverse events |
|
| hospitalization for longer than 24 hours | Respiratory, thoracic and mediastinal disorders | ICD-9 | Systematic Assessment | IRB concluded that this did not meet their definition for a serious adverse event |
|
|
| Medication side effects | Gastrointestinal disorders | ICD-9 | Non-systematic Assessment | nause related to study medication |
|
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| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D002492 |
| Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| At 9 months |
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| 9 months |
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| 9 months |
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| 9 months |
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| 9 months |
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| 9 months |
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