Trial Outcomes & Findings for Interactive Voice Response (IVR)-Based Treatment for Chronic Low Back Pain (NCT NCT01025752)
NCT ID: NCT01025752
Last Updated: 2018-08-03
Results Overview
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.
COMPLETED
NA
134 participants
post-treatment (12 weeks), 3 and 6 months post-baseline
2018-08-03
Participant Flow
Veterans with chronic back pain from VA Connecticut Healthcare System and surrounding community areas were recruited from June 2012-July 2015.
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
63
|
|
Overall Study
COMPLETED
|
54
|
50
|
|
Overall Study
NOT COMPLETED
|
8
|
13
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
10
|
|
Overall Study
Physician Decision
|
1
|
3
|
Baseline Characteristics
Interactive Voice Response (IVR)-Based Treatment for Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Arm 1: IVR CBT
n=62 Participants
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
|
Arm 2: F2F CBT
n=63 Participants
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
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Balck, not Hispanic
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, not Hispanic
|
43 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: post-treatment (12 weeks), 3 and 6 months post-baselinePopulation: 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).
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.
Outcome measures
| Measure |
Arm 1: IVR CBT
n=54 Participants
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
|
Arm 2: F2F CBT
n=50 Participants
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
|
|---|---|---|
|
Change in Numeric Rating Scale of Pain Intensity
post-treatment (12 weeks)
|
-0.77 units on a scale
Interval -1.29 to -0.26
|
-0.84 units on a scale
Interval -1.39 to -0.29
|
|
Change in Numeric Rating Scale of Pain Intensity
3 months post-baseline
|
-1.23 units on a scale
Interval -1.73 to -0.72
|
-1.00 units on a scale
Interval -1.52 to -0.48
|
|
Change in Numeric Rating Scale of Pain Intensity
6 months post-baseline
|
-0.51 units on a scale
Interval -1.06 to 0.04
|
-0.44 units on a scale
Interval -1.01 to 0.14
|
SECONDARY outcome
Timeframe: post-treatment (12 weeks), 3 and 6 months post-baselinePopulation: 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).
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.
Outcome measures
| Measure |
Arm 1: IVR CBT
n=53 Participants
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
|
Arm 2: F2F CBT
n=51 Participants
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
|
|---|---|---|
|
Change in Multidimensional Pain Inventory Interference Subscale
post-treatment (12 weeks)
|
-0.37 units on a scale
Interval -0.66 to -0.08
|
-0.04 units on a scale
Interval -0.35 to 0.26
|
|
Change in Multidimensional Pain Inventory Interference Subscale
3 months post-baseline
|
-0.37 units on a scale
Interval -0.73 to 0.0
|
-0.02 units on a scale
Interval -0.4 to 0.35
|
|
Change in Multidimensional Pain Inventory Interference Subscale
6 months post-baseline
|
-0.12 units on a scale
Interval -0.5 to 0.26
|
-0.09 units on a scale
Interval -0.48 to 0.3
|
SECONDARY outcome
Timeframe: post-treatment (12 weeks), 3 and 6 months post-baselinePopulation: 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).
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.
Outcome measures
| Measure |
Arm 1: IVR CBT
n=53 Participants
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
|
Arm 2: F2F CBT
n=51 Participants
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
|
|---|---|---|
|
Change in Roland Morris Disability Questionnaire
post-treatment (12 weeks)
|
-2.92 units on a scale
Interval -4.16 to -1.69
|
-2.42 units on a scale
Interval -3.74 to -1.11
|
|
Change in Roland Morris Disability Questionnaire
3 months post-baseline
|
-3.38 units on a scale
Interval -4.75 to -2.02
|
-1.86 units on a scale
Interval -3.25 to -0.46
|
|
Change in Roland Morris Disability Questionnaire
6 months post-baseline
|
-2.63 units on a scale
Interval -3.9 to -1.35
|
-2.02 units on a scale
Interval -3.32 to -0.71
|
SECONDARY outcome
Timeframe: post-treatment (12 weeks), 3 and 6 months post-baselinePopulation: 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).
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.
Outcome measures
| Measure |
Arm 1: IVR CBT
n=52 Participants
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
|
Arm 2: F2F CBT
n=48 Participants
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
|
|---|---|---|
|
Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale
post-treatment (12 weeks)
|
2.20 units on a scale
Interval 0.43 to 3.96
|
1.91 units on a scale
Interval 0.01 to 3.81
|
|
Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale
3 months post-baseline
|
2.05 units on a scale
Interval 0.09 to 4.02
|
0.90 units on a scale
Interval -1.15 to 2.95
|
|
Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale
6 months post-baseline
|
1.50 units on a scale
Interval -0.44 to 3.45
|
2.09 units on a scale
Interval 0.03 to 4.14
|
SECONDARY outcome
Timeframe: post-treatment (12 weeks), 3 and 6 months post-baselinePopulation: 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).
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.
Outcome measures
| Measure |
Arm 1: IVR CBT
n=52 Participants
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
|
Arm 2: F2F CBT
n=48 Participants
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
|
|---|---|---|
|
Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale
3 months post-baseline
|
1.39 units on a scale
Interval -0.86 to 3.64
|
1.01 units on a scale
Interval -1.33 to 3.35
|
|
Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale
6 months post-baseline
|
0.96 units on a scale
Interval -1.41 to 3.33
|
-1.47 units on a scale
Interval -3.96 to 1.02
|
|
Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale
post-treatment (12 weeks)
|
1.67 units on a scale
Interval -0.36 to 3.71
|
0.42 units on a scale
Interval -1.74 to 2.59
|
SECONDARY outcome
Timeframe: post-treatment (12 weeks), 3 and 6 months post-baselinePopulation: 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).
Depressive symptom severity was assessed using the BDI-II, higher scores indicate more depressive symptomology, range 0-63. We computed the change from baseline.
Outcome measures
| Measure |
Arm 1: IVR CBT
n=54 Participants
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
|
Arm 2: F2F CBT
n=51 Participants
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
|
|---|---|---|
|
Change in Beck Depression Inventory-II
post-treatment (12 weeks)
|
-1.00 units on a scale
Interval -2.79 to 0.78
|
-1.25 units on a scale
Interval -3.14 to 0.65
|
|
Change in Beck Depression Inventory-II
3 months post-baseline
|
-0.49 units on a scale
Interval -2.61 to 1.64
|
0.78 units on a scale
Interval -1.4 to 2.96
|
|
Change in Beck Depression Inventory-II
6 months post-baseline
|
0.89 units on a scale
Interval -1.62 to 3.4
|
1.62 units on a scale
Interval -0.97 to 4.21
|
SECONDARY outcome
Timeframe: post-treatment (12 weeks), 3 and 6 months post-baselinePopulation: 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).
The PSQI assess sleep quality, with lower scores indicating better sleep, range 0 to 21.We computed the change from baseline.
Outcome measures
| Measure |
Arm 1: IVR CBT
n=48 Participants
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
|
Arm 2: F2F CBT
n=49 Participants
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
|
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index
post-treatment (12 weeks)
|
-2.03 units on a scale
Interval -2.94 to -1.12
|
-1.09 units on a scale
Interval -2.06 to -0.11
|
|
Change in Pittsburgh Sleep Quality Index
3 months post-baseline
|
-1.33 units on a scale
Interval -2.21 to -0.44
|
-1.21 units on a scale
Interval -2.12 to -0.29
|
|
Change in Pittsburgh Sleep Quality Index
6 months post-baseline
|
-0.87 units on a scale
Interval -1.99 to 0.24
|
-1.25 units on a scale
Interval -2.38 to -0.11
|
Adverse Events
Arm 1: IVR CBT
Arm 2: F2F CBT
Serious adverse events
| Measure |
Arm 1: IVR CBT
n=62 participants at risk
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
|
Arm 2: F2F CBT
n=63 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Infection of foot lesion
|
0.00%
0/62
|
1.6%
1/63 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder event
|
1.6%
1/62 • Number of events 1
|
0.00%
0/63
|
Other adverse events
| Measure |
Arm 1: IVR CBT
n=62 participants at risk
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
|
Arm 2: F2F CBT
n=63 participants at risk
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
|
|---|---|---|
|
General disorders
Trip or Fall
|
8.1%
5/62 • Number of events 5
|
9.5%
6/63 • Number of events 7
|
|
General disorders
Muscle or joint pain increase
|
17.7%
11/62 • Number of events 19
|
23.8%
15/63 • Number of events 19
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place