N/A
Completed N=1,817
Improving Veteran Access to Integrated Management of Back Pain
Low Back Pain · Veterans Family
Source: ClinicalTrials.gov NCT04411420 ↗
Enrolled (actual)
1,817
Serious AEs
4.8%
Results posted
Jun 2025
Primary outcomePrimary: Change in Pain Interference Measure — -2.67; -2.04 T-score — p=0.169
Summary
The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Interference Measure |
-2.67; -2.04 | 0.169 |
| PRIMARY Change in Physical Function Measure |
1.87; 1.44 | 0.139 |
| SECONDARY Change in Sleep Disturbance |
-2.56; -2.06 | 0.417 |
| SECONDARY Change in Patient Reported Outcomes--PROMIS Sleep Disturbance |
-1.35; -1.07; -1.50; -1.66; -1.25; -1.26 | 0.409 |
| SECONDARY Number of Participants With Opioid Use--Chronic User |
28; 36; 22; 26 | 0.992 |
| SECONDARY Change in Opioid Use - Morphine Dose |
-2.62; -2.69 | 0.262 |
| SECONDARY Change in Patient Reported Outcomes--PROMIS Pain Interference |
-1.44; -1.10; -1.64; -1.22; -1.77; -1.31 | 0.37 |
| SECONDARY Change in Patient Reported Outcomes--PROMIS Physical Function |
-0.20; -0.15; 0.24; 0.14; -0.09; 0.08 | 0.727 |
Eligibility Criteria
Clinic eligibility:
- Volunteer and return signed clinic participation agreement
- Availability of clinical personnel willing to deliver the treatment interventions (in either arm).
- Staff and location need to be distinct from other enrolled clinics.
- Clinics can have a variable number of providers, but together meet criteria for range of monthly visits for low back pain.
Participant Survey Eligibility Criteria:
Inclusion Criteria
- Age >= 18
- Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic
- Provider determines LBP is appropriate for conservative management
- Referred to integrated ICP pathway or CCP pathway by participating clinic provider
Exclusion Criteria
- Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults)
- No documented phone number in the electronic health record.
Data sourced from ClinicalTrials.gov (NCT04411420). 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.