N/A
Completed N=125
Interactive Voice Response (IVR)-Based Treatment for Chronic Low Back Pain
Source: ClinicalTrials.gov NCT01025752 ↗Enrolled (actual)
125
Serious AEs
1.6%
Results posted
Aug 2018
Primary outcomePrimary: Change in Numeric Rating Scale of Pain Intensity — -0.77; -0.84; -1.23; -1.00 units on a scale — p=0.007
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Numeric Rating Scale of Pain Intensity |
-0.77; -0.84; -1.23; -1.00; -0.51; -0.44 | 0.007 sig |
| SECONDARY Change in Multidimensional Pain Inventory Interference Subscale |
-0.37; -0.04; -0.37; -0.02; -0.12; -0.09 | 0.12 |
| SECONDARY Change in Roland Morris Disability Questionnaire |
-2.92; -2.42; -3.38; -1.86; -2.63; -2.02 | 0.58 |
| SECONDARY Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale |
2.20; 1.91; 2.05; 0.90; 1.50; 2.09 | 0.83 |
| SECONDARY Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale |
1.67; 0.42; 1.39; 1.01; 0.96; -1.47 | 0.40 |
| SECONDARY Change in Beck Depression Inventory-II |
-1.00; -1.25; -0.49; 0.78; 0.89; 1.62 | 0.85 |
| SECONDARY Change in Pittsburgh Sleep Quality Index |
-2.03; -1.09; -1.33; -1.21; -0.87; -1.25 | 0.17 |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01025752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.