N/A
Completed N=3,603
Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health
Chronic Musculoskeletal Pain
Source: ClinicalTrials.gov NCT05097521 ↗
Enrolled (actual)
3,603
Serious AEs
—
Results posted
May 2026
Primary outcomePrimary: Brief Pain Inventory (BPI) Severity Scale — 5.9; 6.0; 6.3; 5.3 units on a scale — p=0.160
Summary
The APPROACH Study (Assessing Pain, Patient-Reported Outcomes and Complementary and Integrative Health) assesses the effects of use of practitioner-delivered CIH therapies alone compared to the combination of self-care and practitioner-delivered CIH therapies among Veterans with chronic musculoskeletal pain. The APPROACH study is predominately conducting a secondary analysis of patient-reported data being collected by the Veterans Health Administration's (VA) Office of Patient Centered Care and Cultural Transformation among Veterans receiving care at one of 18 VA medical centers. Those 18 facilities received funding to expand availability of CIH therapies as part of the Comprehensive Addiction and Recovery Act of 2016. That patient-reported data is being supplemented with VA electronic health record data and data on the 18 medical centers' business practices (nudges, the instrumental variable). Practitioner-delivered therapies under study include chiropractic care, acupuncture, and therapeutic massage; self-care therapies include Tai Chi/Qigong, yoga, and meditation. The primary outcomes are improvement in pain severity and pain interference, assessed using the Brief Pain Inventory (BPI), six months after initiating CIH therapies compared to baseline. Patients will enter treatment groups based on the CIH therapies they use, as randomizing patients to specific therapies would require withholding therapies routinely offered at VA. The investigators will address selection bias and confounding by using sites' variations in business practices and other encouragements (nudges) to receiving different CIH therapies as a surrogate for direct randomization using instrumental variables econometric methods.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Pain Inventory (BPI) Severity Scale |
5.9; 6.0; 6.3; 5.3; 5.4; 5.9 | 0.160 |
| PRIMARY Brief Pain Inventory (BPI) Interference Scale |
6.3; 6.6; 6.8; 5.7; 5.9; 6.4 | 0.847 |
| SECONDARY Patient Global Impression of Change (PGIC) for Improvement in Pain |
821; 868; 104; 867; 750; 193 | <0.001 sig |
| SECONDARY Patient Global Impression of Change (PGIC) for Improvement in Mental Health |
478; 702; 115; 1203; 909; 182 | <0.001 sig |
| SECONDARY Patient Global Impression of Change (PGIC) for Improvement in Fatigue |
441; 556; 89; 1237; 1051; 208 | <0.001 sig |
| SECONDARY Patient Global Impression of Change (PGIC) for Improvement in Overall Well-being |
665; 844; 125; 1011; 761; 172 | <0.001 sig |
| SECONDARY PROMIS10 Global Assessment of Physical Health |
37.4; 36.8; 35.0; 38.3; 37.9; 35.7 | 0.024 sig |
| SECONDARY PROMIS10 Global Assessment of Mental Health |
41.0; 38.9; 37.3; 41.5; 39.7; 38.2 | 0.039 sig |
| SECONDARY Life Engagement Test (LET) |
23.2; 22.6; 21.4; 23.2; 22.7; 21.7 | 0.502 |
| SECONDARY Perceived Stress Scale (PSS-4) |
5.9; 6.8; 7.5; 5.7; 6.4; 7.1 | 0.346 |
| SECONDARY Patient Health Questionnaire (PHQ2) |
2.3; 2.6; 3.0; 2.1; 2.4; 2.7 | 0.761 |
Eligibility Criteria
Inclusion Criteria
- Veteran
- History of (chronic) musculoskeletal-related pain conditions recorded in the EHR in the year prior to the index visit, and self-report pain present every day or nearly every day for 3 months from the CIH index visit using an eligibility screener
- Aged 18-89 on index CIH visit date
Exclusion Criteria
- Diagnoses of serious mental illness in the year prior to initiating CIH
- History of spinal cord injury
- Hospitalization 30 days prior to initiating CIH
- Recorded CIH use in the EHR in the 6 months prior to the index CIH visit and reported CIH use in the 8 weeks prior to index CIH visit
Data sourced from ClinicalTrials.gov (NCT05097521). 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.