Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health
CompletedNCT05097521
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Complementary and Integrative Health for Pain in the VA: A National Demonstration Project (NIH-VA-DOD Joint Initiative)
- Conditions
- Interventions
- Other: Practitioner-delivered CIH therapies
- Other: Combination of practitioner-delivered and self-care CIH therapies
- Other: Self-care CIH therapies
- Sponsor
- VA Office of Research and Development
- Collaborators
- Veterans Health Administration Office of Patient Centered Care & Cultural Transformation
- Start date
- 2021-03-17
- Primary completion
- 2023-09-17
- Sex
- All
- Age range
- from 18 Years to 89 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05097521