Chronic Low Back Pain
Conditions
Keywords
chronic pain, cognitive behavior therapy, low back pain
Brief summary
The proposed study will test how well an innovative method, interactive voice response (IVR), can be used for delivering an treatment for chronic low back pain. The use of IVR will improve the accessibility of treatment to Veterans. IVR is a computerized interface that allows patients to use their telephone to: 1) obtain pre-recorded didactic information, 2) report data regarding pain-related symptoms and adherence to pain coping skill practice, and 3) receive personalized therapist feedback. Although CBT has been shown to be effective in reducing pain intensity, traditional CBT requires patients to make frequent office visits. The use of IVR will allow Veterans to access CBT from their home via a touch-tone telephone, thereby allowing them to access treatment at their convenience without travel to the VA for an outpatient appointment. Veterans with chronic low back pain will be randomized in equal numbers to receive either standard CBT or IVR-based CBT. Veterans in both conditions will receive 10 session of treatment designed to help them manage their chronic pain using pain coping skills. The primary outcome measure will be pain intensity.
Detailed description
OBJECTIVES: The primary purpose of this study is to test the efficacy of an innovative method, interactive voice response (IVR), for delivering an empirically validated psychological (cognitive behavior therapy \[CBT\]) treatment for chronic pain in order to improve access and sustainability of this intervention. The primary clinical equivalence hypothesis states that Veterans with chronic low back pain (CLBP) receiving IVR-based CBT (ICBT) will demonstrate, relative to standard face-to-face CBT (CBT), equivalent declines in reports of pain intensity as measured by the numeric rating scale at post-treatment and follow-up. The secondary hypothesis states that Veterans with CLBP receiving ICBT, relative to CBT, will demonstrate equivalent declines in reports of pain-related interference and emotional distress at post-treatment and follow-up. RESEARCH DESIGN: A randomized design will be employed in which standard CBT (CBT) is compared to an Interactive CBT (ICBT) treatment condition. Participants will be randomized in equal numbers to both conditions. Repeated assessments of key outcome domains will occur at pretreatment/baseline and at 3 and 6 months following baseline. METHODOLOGY: Subjects will be 230 patients receiving care at the VA Connecticut Healthcare System who report chronic low back pain. The primary criteria for inclusion are constant pain of at least three months duration with at least a moderate level of average pain (i.e., scores of 4 or greater on a 0 (no pain) to 10 (worst pain imaginable) on a numerical rating scale of average pain. All patients must have access to a touch-tone telephone. Excluded will be patients with life threatening or acute physical illness, current alcohol or substance abuse or dependence, current psychosis, suicidal ideation, dementia, and individuals seeking surgical pain treatment. Comprehensive evaluations will be conducted at each assessment interval. Following completion of written consent and an initial baseline evaluation, participants will be randomized to one of the two treatments. Sessions will be audiotaped to ensure the fidelity of the face-to-face CBT sessions and the personalized therapist feedback in the IVR-based CBT condition. Both conditions will involve 10 outpatient therapy sessions with a psychologist trained experienced in the delivery of these treatments. Adherence to coping skill practice will be assessed using IVR for both treatment groups. Analysis of primary and secondary outcome measures will employ mixed-effects models, which will account for the clustering induced by repeated measures on individual patients.
Interventions
BEHAVIORALFace to face cognitive behavior therapy
Ten session face to face cognitive behavior therapy for chronic low back pain
BEHAVIORALIVR based cognitive behavioral therapy
Ten session cognitive behavior therapy for chronic low back pain using interactive voice response therapy
Sponsors
University of Michigan
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
* presence of at least a moderate level of pain (i.e., pain scores of \> or = 4) and presence of pain for a period of \> or = 3 months * ability to participate safely in the walking portion of the intervention as evidenced by ability to walk at least one block * availability of a touch-tone telephone and computer with internet access in the participant's residence * Veteran receiving care at VA Connecticut Healthcare System
Exclusion criteria
* life threatening or acute medical condition that could impair participation (e.g., severe chronic obstructive pulmonary disease, lower limb amputation, terminal cancer); * psychiatric condition (e.g., active substance abuse, psychosis or suicidality) that could impair participation * surgical interventions for pain during their participation in this study * sensory deficits that would impair participation (e.g., hearing loss to a degree that telephone usage is not possible).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numeric Rating Scale of Pain Intensity | post-treatment (12 weeks), 3 and 6 months post-baseline | An 11-point NRS for pain was administered to patients, with 0 representing No Pain and 10 representing Worst Possible Pain. Patients were asked to rate the level of pain that best represented their experience of worst pain, least pain and average pain over the past week. We computed the change from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Roland Morris Disability Questionnaire | post-treatment (12 weeks), 3 and 6 months post-baseline | The RMDQ (Roland & Morris, 1983) is a 24-item checklist designed for patients to identify the level of disability and functional status associated with chronic low back pain. Patients are instructed to endorse items that describe their functional status that day. Scores range from 0-24, with higher scores indicating more disability. We computed the change from baseline. |
| Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale | post-treatment (12 weeks), 3 and 6 months post-baseline | The SF-36V is an adaptation of the Medical Outcomes Study SF-36 (Ware & Sherbourne, 1992) intended to apply to veteran-specific health-related quality of life. The SF-36 can also be divided into two aggregate summary measures the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The lower the score, the more disability, range 0-100. We computed the change from baseline. |
| Change in Multidimensional Pain Inventory Interference Subscale | post-treatment (12 weeks), 3 and 6 months post-baseline | The interference subscale of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI) assesses pain-related interference with quality of life. Scores ranging from 0-6, with higher scores indicating more interference. We computed the change from baseline. |
| Change in Beck Depression Inventory-II | post-treatment (12 weeks), 3 and 6 months post-baseline | Depressive symptom severity was assessed using the BDI-II, higher scores indicate more depressive symptomology, range 0-63. We computed the change from baseline. |
| Change in Pittsburgh Sleep Quality Index | post-treatment (12 weeks), 3 and 6 months post-baseline | The PSQI assess sleep quality, with lower scores indicating better sleep, range 0 to 21.We computed the change from baseline. |
| Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale | post-treatment (12 weeks), 3 and 6 months post-baseline | The SF-36V is an adaptation of the Medical Outcomes Study SF-36 (Ware & Sherbourne, 1992) intended to apply to veteran-specific health-related quality of life. The SF-36 can also be divided into two aggregate summary measures the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The lower the score, the more disability, range 0-100. We computed the change from baseline. |
Countries
United States
Participant flow
Recruitment details
Veterans with chronic back pain from VA Connecticut Healthcare System and surrounding community areas were recruited from June 2012-July 2015.
Pre-assignment details
Eligibility screening was conducted by the research assistant via interview and medical record review. Participants who enrolled then subsequently found ineligible from further baseline assessment questionnaires were not randomized to a treatment arm, and excluded from the study (i.e. substance abuse, severe depression, cognitive impairment), n=9.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: IVR CBT Ten session IVR-based cognitive behavior therapy for chronic low back pain
IVR based cognitive behavioral therapy: Ten session cognitive behavior therapy for chronic low back pain using interactive voice response therapy | 62 |
| Arm 2: F2F CBT Ten session face to face cognitive behavior therapy for chronic low back pain
Face to face cognitive behavior therapy: Ten session face to face cognitive behavior therapy for chronic low back pain | 63 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 10 |
| Overall Study | Physician Decision | 1 | 3 |
Baseline characteristics
| Characteristic | Arm 2: F2F CBT | Total | Arm 1: IVR CBT |
|---|---|---|---|
| Age, Continuous | 56.7 years STANDARD_DEVIATION 11.5 | 57.9 years STANDARD_DEVIATION 11.6 | 59.2 years STANDARD_DEVIATION 11.8 |
| Race/Ethnicity, Customized Balck, not Hispanic | 18 Participants | 32 Participants | 14 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants | 9 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized White, not Hispanic | 37 Participants | 80 Participants | 43 Participants |
| Region of Enrollment United States | 63 Participants | 125 Participants | 62 Participants |
| Sex: Female, Male Female | 15 Participants | 28 Participants | 13 Participants |
| Sex: Female, Male Male | 48 Participants | 97 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 62 | 19 / 63 |
| serious Total, serious adverse events | 1 / 62 | 1 / 63 |
Outcome results
Primary
Change in Numeric Rating Scale of Pain Intensity
An 11-point NRS for pain was administered to patients, with 0 representing No Pain and 10 representing Worst Possible Pain. Patients were asked to rate the level of pain that best represented their experience of worst pain, least pain and average pain over the past week. We computed the change from baseline.
Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline
Population: The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm 1: IVR CBT | Change in Numeric Rating Scale of Pain Intensity | 3 months post-baseline | -1.23 units on a scale |
| Arm 1: IVR CBT | Change in Numeric Rating Scale of Pain Intensity | 6 months post-baseline | -0.51 units on a scale |
| Arm 1: IVR CBT | Change in Numeric Rating Scale of Pain Intensity | post-treatment (12 weeks) | -0.77 units on a scale |
| Arm 2: F2F CBT | Change in Numeric Rating Scale of Pain Intensity | post-treatment (12 weeks) | -0.84 units on a scale |
| Arm 2: F2F CBT | Change in Numeric Rating Scale of Pain Intensity | 6 months post-baseline | -0.44 units on a scale |
| Arm 2: F2F CBT | Change in Numeric Rating Scale of Pain Intensity | 3 months post-baseline | -1.00 units on a scale |
Comparison: post-treatment (12 weeks) time pointp-value: 0.00795% CI: [-0.67, 0.8]Mixed Models Analysis
Comparison: 3 month post-baseline time pointp-value: <0.000195% CI: [-0.94, 0.49]Mixed Models Analysis
Comparison: 6 month post- baseline time point.p-value: 0.00495% CI: [-0.86, 0.71]Mixed Models Analysis
Secondary
Change in Beck Depression Inventory-II
Depressive symptom severity was assessed using the BDI-II, higher scores indicate more depressive symptomology, range 0-63. We computed the change from baseline.
Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline
Population: The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm 1: IVR CBT | Change in Beck Depression Inventory-II | post-treatment (12 weeks) | -1.00 units on a scale |
| Arm 1: IVR CBT | Change in Beck Depression Inventory-II | 3 months post-baseline | -0.49 units on a scale |
| Arm 1: IVR CBT | Change in Beck Depression Inventory-II | 6 months post-baseline | 0.89 units on a scale |
| Arm 2: F2F CBT | Change in Beck Depression Inventory-II | 3 months post-baseline | 0.78 units on a scale |
| Arm 2: F2F CBT | Change in Beck Depression Inventory-II | 6 months post-baseline | 1.62 units on a scale |
| Arm 2: F2F CBT | Change in Beck Depression Inventory-II | post-treatment (12 weeks) | -1.25 units on a scale |
Comparison: post-treatment (12 weeks time point). (Mean difference of IVR CBT- F2F CBT)p-value: 0.8595% CI: [-2.32, 2.8]Mixed Models Analysis
Comparison: 3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)p-value: 0.495% CI: [-4.27, 1.73]Mixed Models Analysis
Comparison: 6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)p-value: 0.6895% CI: [-4.3, 2.83]Mixed Models Analysis
Secondary
Change in Multidimensional Pain Inventory Interference Subscale
The interference subscale of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI) assesses pain-related interference with quality of life. Scores ranging from 0-6, with higher scores indicating more interference. We computed the change from baseline.
Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline
Population: The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm 1: IVR CBT | Change in Multidimensional Pain Inventory Interference Subscale | post-treatment (12 weeks) | -0.37 units on a scale |
| Arm 1: IVR CBT | Change in Multidimensional Pain Inventory Interference Subscale | 3 months post-baseline | -0.37 units on a scale |
| Arm 1: IVR CBT | Change in Multidimensional Pain Inventory Interference Subscale | 6 months post-baseline | -0.12 units on a scale |
| Arm 2: F2F CBT | Change in Multidimensional Pain Inventory Interference Subscale | post-treatment (12 weeks) | -0.04 units on a scale |
| Arm 2: F2F CBT | Change in Multidimensional Pain Inventory Interference Subscale | 3 months post-baseline | -0.02 units on a scale |
| Arm 2: F2F CBT | Change in Multidimensional Pain Inventory Interference Subscale | 6 months post-baseline | -0.09 units on a scale |
Comparison: Post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)p-value: 0.1295% CI: [-0.74, 0.09]Mixed Models Analysis
Comparison: 3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)p-value: 0.295% CI: [-0.87, 0.18]Mixed Models Analysis
Comparison: 6 months post baseline time point. (Mean difference of IVR CBT- F2F CBT)p-value: 0.9395% CI: [-0.57, 0.52]Mixed Models Analysis
Secondary
Change in Pittsburgh Sleep Quality Index
The PSQI assess sleep quality, with lower scores indicating better sleep, range 0 to 21.We computed the change from baseline.
Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline
Population: The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm 1: IVR CBT | Change in Pittsburgh Sleep Quality Index | post-treatment (12 weeks) | -2.03 units on a scale |
| Arm 1: IVR CBT | Change in Pittsburgh Sleep Quality Index | 3 months post-baseline | -1.33 units on a scale |
| Arm 1: IVR CBT | Change in Pittsburgh Sleep Quality Index | 6 months post-baseline | -0.87 units on a scale |
| Arm 2: F2F CBT | Change in Pittsburgh Sleep Quality Index | post-treatment (12 weeks) | -1.09 units on a scale |
| Arm 2: F2F CBT | Change in Pittsburgh Sleep Quality Index | 3 months post-baseline | -1.21 units on a scale |
| Arm 2: F2F CBT | Change in Pittsburgh Sleep Quality Index | 6 months post-baseline | -1.25 units on a scale |
Comparison: post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)p-value: 0.1795% CI: [-2.28, 0.4]Mixed Models Analysis
Comparison: 3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)p-value: 0.8695% CI: [-1.39, 1.16]Mixed Models Analysis
Comparison: 6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)p-value: 0.6495% CI: [-1.22, 1.97]Mixed Models Analysis
Secondary
Change in Roland Morris Disability Questionnaire
The RMDQ (Roland & Morris, 1983) is a 24-item checklist designed for patients to identify the level of disability and functional status associated with chronic low back pain. Patients are instructed to endorse items that describe their functional status that day. Scores range from 0-24, with higher scores indicating more disability. We computed the change from baseline.
Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline
Population: The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm 1: IVR CBT | Change in Roland Morris Disability Questionnaire | post-treatment (12 weeks) | -2.92 units on a scale |
| Arm 1: IVR CBT | Change in Roland Morris Disability Questionnaire | 3 months post-baseline | -3.38 units on a scale |
| Arm 1: IVR CBT | Change in Roland Morris Disability Questionnaire | 6 months post-baseline | -2.63 units on a scale |
| Arm 2: F2F CBT | Change in Roland Morris Disability Questionnaire | post-treatment (12 weeks) | -2.42 units on a scale |
| Arm 2: F2F CBT | Change in Roland Morris Disability Questionnaire | 3 months post-baseline | -1.86 units on a scale |
| Arm 2: F2F CBT | Change in Roland Morris Disability Questionnaire | 6 months post-baseline | -2.02 units on a scale |
Comparison: post-treatment (12 weeks) time pointp-value: 0.5895% CI: [-2.29, 1.29]Mixed Models Analysis
Comparison: 3 months post-baseline time pointp-value: 0.1295% CI: [-3.46, 0.41]Mixed Models Analysis
Comparison: 6 months post-baseline time pointp-value: 0.5195% CI: [-2.42, 1.2]Mixed Models Analysis
Secondary
Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale
The SF-36V is an adaptation of the Medical Outcomes Study SF-36 (Ware & Sherbourne, 1992) intended to apply to veteran-specific health-related quality of life. The SF-36 can also be divided into two aggregate summary measures the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The lower the score, the more disability, range 0-100. We computed the change from baseline.
Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline
Population: The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm 1: IVR CBT | Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale | 3 months post-baseline | 1.39 units on a scale |
| Arm 1: IVR CBT | Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale | 6 months post-baseline | 0.96 units on a scale |
| Arm 1: IVR CBT | Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale | post-treatment (12 weeks) | 1.67 units on a scale |
| Arm 2: F2F CBT | Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale | 3 months post-baseline | 1.01 units on a scale |
| Arm 2: F2F CBT | Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale | 6 months post-baseline | -1.47 units on a scale |
| Arm 2: F2F CBT | Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale | post-treatment (12 weeks) | 0.42 units on a scale |
Comparison: post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)p-value: 0.495% CI: [-1.66, 4.16]Mixed Models Analysis
Comparison: 3 months post-baseline. (Mean difference of IVR CBT- F2F CBT)p-value: 0.8195% CI: [-2.82, 3.58]Mixed Models Analysis
Comparison: 6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)p-value: 0.1695% CI: [-0.96, 5.82]Mixed Models Analysis
Secondary
Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale
The SF-36V is an adaptation of the Medical Outcomes Study SF-36 (Ware & Sherbourne, 1992) intended to apply to veteran-specific health-related quality of life. The SF-36 can also be divided into two aggregate summary measures the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The lower the score, the more disability, range 0-100. We computed the change from baseline.
Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline
Population: The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm 1: IVR CBT | Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale | post-treatment (12 weeks) | 2.20 units on a scale |
| Arm 1: IVR CBT | Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale | 3 months post-baseline | 2.05 units on a scale |
| Arm 1: IVR CBT | Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale | 6 months post-baseline | 1.50 units on a scale |
| Arm 2: F2F CBT | Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale | post-treatment (12 weeks) | 1.91 units on a scale |
| Arm 2: F2F CBT | Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale | 3 months post-baseline | 0.90 units on a scale |
| Arm 2: F2F CBT | Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale | 6 months post-baseline | 2.09 units on a scale |
Comparison: post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)p-value: 0.8395% CI: [-2.3, 2.87]Mixed Models Analysis
Comparison: 3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)p-value: 0.4295% CI: [-1.68, 3.98]Mixed Models Analysis
Comparison: 6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)p-value: 0.6895% CI: [-3.4, 2.24]Mixed Models Analysis