N/A
Completed N=278
Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools
Back Pain
Source: ClinicalTrials.gov NCT02464449 ↗
Enrolled (actual)
278
Serious AEs
2.9%
Results posted
Sep 2021
Primary outcomePrimary: Pain-related Disability — 11.0; 11.3; 11.0; 12.6 units on a scale
Summary
This study will evaluate a new approach for back pain care management using artificial intelligence and evidence-based cognitive behavioral therapy (AI-CBT) so that services automatically adapt to each Veteran's unique needs, achieving outcomes as good as standard care but with less clinician time.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain-related Disability |
11.0; 11.3; 11.0; 12.6 | — |
| SECONDARY Global Pain Intensity |
5.1; 5.0; 5.3; 5.7 | — |
| SECONDARY Pain-Related Interference |
3.9; 3.8; 3.9; 4.5 | — |
| SECONDARY Depression Symptom Severity |
6.7; 6.7; 6.8; 7.5 | — |
Eligibility Criteria
Inclusion Criteria
- Back pain-related dx including back and spine conditions and nerve compression and a score of >=4 (indicating moderate pain) on the 0-10 Numerical Rating Scale on at least two separate outpatient encounters in the past year
- At least 1 outpatient visit in last 12 months
- At least moderate pain-related disability as determined by a score of 5+on the Roland Morris Disability Questionnaire
- At least moderate musculoskeletal pain as indicated by a pain score of >=4 on the Numeric Rating Scale
- Pain on at least half the days of the prior 6 months as reported on the Chronic Pain item
- Touch-tone cell or land line phone.
Exclusion Criteria
- COPD requiring oxygen
- Cancer requiring chemotherapy
- Currently receiving CBT
- Suicidality
- Receiving surgical tx related to back pain
- Active psychotic symptoms
- Severe depressive symptoms
- Can't speak English
- Sensory deficits that would impair participation in telephone calls
- Patient not planning to get care at study site
- PCP not affiliated with study site
- Limited life expectancy (COPD requiring oxygen or Cancer requiring chemotherapy
- Active psychotic symptoms, suicidality, severe depressive symptoms (Beck Depression Inventory (BDI) score or 30+)
- Substance use disorder or dependence, active manic episode, or poorly controlled bipolar disorder as identified by MMini International Neuropsychiatric Interview
- Severe depression identified by chart review of diagnoses and mental health treatment notes
- Cognitive impairment defined by a score of <=5 on the Six-Item screener
- Current CBT or surgical treatment related to back pain.
Data sourced from ClinicalTrials.gov (NCT02464449). 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.