Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health

Completed

Conditions studied: Chronic Musculoskeletal Pain

In brief

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.

Key facts

Study ID

NCT05097521

Run by

VA Office of Research and Development

People needed

3603

Starts

2021-03-17

Expected to finish

2023-09-17

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Greater Los Angeles Healthcare System, Sepulveda, CA — Sepulveda, California, United States
• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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