Low Back Pain, Pain, Pain, Intractable
Conditions
Keywords
analgesia, analgesics, cognitive behavioral therapy, Pain, self-management, stepped care, musculoskeletal pain
Brief summary
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: 1. Stepped care is more effective than usual care in reducing pain-related disability 2. Stepped care is more effective than usual care in reducing psychological distress
Detailed description
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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALPain 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.
DRUGCo-Analgesic Therapy
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
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)
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* have musculoskeletal pain of the low back, cervical spine, or extremities * have chronic pain (\>3 months duration) * have moderate functional impairment * have access to a working telephone * Indianapolis Roudebush VA Medical Center patient or Walter Reed Army Medical Center patient * willing to travel at least once to study site
Exclusion criteria
* prior back or cervical spine surgery or surgery pending * active psychosis * incompetent for interview * severe impairment of hearing or speech * active suicidal ideation * current alcohol or other substance dependence or abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Roland-Morris Disability Questionnaire | at baseline and 9 months | 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. |
| Brief Pain Inventory (Interference) | Baseline and 9 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-Mental Component Summary (MCS) | Baseline and 9 months | 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 |
| PHQ-9 Depression | Baseline and 9 months | This measure assesses depression symptoms on a 0 to 27 scale with higher scores representing more severe depression |
| PTSD Checklist-17 Civilian Version (PCL-C) | Baseline and 9 months | 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. |
| GAD-7 Anxiety Score | Baseline and 9 months | This 7-item scale assesses anxiety symptoms on a 0 to 21 scale with higher scores representing more severe anxiety symptoms |
| Pain Catastrophizing Scale (PCS) | Baseline and 9 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 121 |
| 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 | 121 |
| Total | 242 |
Baseline characteristics
| Characteristic | Stepped Care | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 120 Participants | 121 Participants | 241 Participants |
| Age, Continuous | 36.4 years STANDARD_DEVIATION 10.1 | 38.2 years STANDARD_DEVIATION 10.5 | 36.7 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 121 participants | 121 participants | 242 participants |
| Sex: Female, Male Female | 12 Participants | 16 Participants | 28 Participants |
| Sex: Female, Male Male | 109 Participants | 105 Participants | 214 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 121 | 4 / 121 |
| serious Total, serious adverse events | 1 / 121 | 6 / 121 |
Outcome results
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).
Time frame: Baseline and 9 months
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Brief Pain Inventory (Interference) | At Baseline | 5.4 units on a scale | Standard Deviation 2.4 |
| Usual Care | Brief Pain Inventory (Interference) | At 9 months | 4.5 units on a scale | Standard Deviation 2.7 |
| Stepped Care | Brief Pain Inventory (Interference) | At Baseline | 5.3 units on a scale | Standard Deviation 2.1 |
| Stepped Care | Brief Pain Inventory (Interference) | At 9 months | 3.8 units on a scale | Standard Deviation 2.6 |
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.
Time frame: at baseline and 9 months
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Roland-Morris Disability Questionnaire | 9 months | 12.1 scores on a scale | Standard Deviation 6.4 |
| Usual Care | Roland-Morris Disability Questionnaire | baseline | 13.7 scores on a scale | Standard Deviation 4.7 |
| Stepped Care | Roland-Morris Disability Questionnaire | baseline | 14.0 scores on a scale | Standard Deviation 4.3 |
| Stepped Care | Roland-Morris Disability Questionnaire | 9 months | 10.6 scores on a scale | Standard Deviation 6.3 |
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
Time frame: Baseline and 9 months
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | GAD-7 Anxiety Score | Baseline | 8.66 units on a scale | Standard Deviation 5.22 |
| Usual Care | GAD-7 Anxiety Score | 9 months | 7.85 units on a scale | Standard Deviation 5.5 |
| Stepped Care | GAD-7 Anxiety Score | Baseline | 8.95 units on a scale | Standard Deviation 5.3 |
| Stepped Care | GAD-7 Anxiety Score | 9 months | 7.89 units on a scale | Standard Deviation 5.55 |
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.
Time frame: Baseline and 9 months
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Pain Catastrophizing Scale (PCS) | 9 months | 18.40 units on a scale | Standard Deviation 13.46 |
| Usual Care | Pain Catastrophizing Scale (PCS) | Baseline | 21.81 units on a scale | Standard Deviation 12.38 |
| Stepped Care | Pain Catastrophizing Scale (PCS) | 9 months | 16.63 units on a scale | Standard Deviation 12.29 |
| Stepped Care | Pain Catastrophizing Scale (PCS) | Baseline | 21.44 units on a scale | Standard Deviation 12.26 |
Secondary
PHQ-9 Depression
This measure assesses depression symptoms on a 0 to 27 scale with higher scores representing more severe depression
Time frame: Baseline and 9 months
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | PHQ-9 Depression | Baseline | 11.3 scores on a scale | Standard Deviation 5.64 |
| Usual Care | PHQ-9 Depression | 9 months | 10.0 scores on a scale | Standard Deviation 6.34 |
| Stepped Care | PHQ-9 Depression | Baseline | 11.05 scores on a scale | Standard Deviation 6.18 |
| Stepped Care | PHQ-9 Depression | 9 months | 9.45 scores on a scale | Standard Deviation 6.84 |
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.
Time frame: Baseline and 9 months
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | PTSD Checklist-17 Civilian Version (PCL-C) | Baseline | 25.15 score on a scale | Standard Deviation 19.74 |
| Usual Care | PTSD Checklist-17 Civilian Version (PCL-C) | 9 months | 22.71 score on a scale | Standard Deviation 19.15 |
| Stepped Care | PTSD Checklist-17 Civilian Version (PCL-C) | Baseline | 27.62 score on a scale | Standard Deviation 19.24 |
| Stepped Care | PTSD Checklist-17 Civilian Version (PCL-C) | 9 months | 24.28 score on a scale | Standard Deviation 19.07 |
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
Time frame: Baseline and 9 months
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | SF-Mental Component Summary (MCS) | Baseline | 41.4 units on a scale | Standard Deviation 13.2 |
| Usual Care | SF-Mental Component Summary (MCS) | 9 months | 42.4 units on a scale | Standard Deviation 12.5 |
| Stepped Care | SF-Mental Component Summary (MCS) | Baseline | 41.9 units on a scale | Standard Deviation 12.1 |
| Stepped Care | SF-Mental Component Summary (MCS) | 9 months | 42.2 units on a scale | Standard Deviation 13.1 |