CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,603 enrolled
Drug / intervention
Practitioner-delivered CIH therapies +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05097521
NCT05097521N/ACompleted

Complementary and Integrative Health for Pain in the VA: A National Demonstration Project (NIH-VA-DOD Joint Initiative)

VA Office of Research and Development·observational·Posted Oct 28, 2021·Updated May 4, 2026

In Brief

An observational study evaluating Practitioner-delivered CIH therapies, Combination of practitioner-delivered and self-care CIH therapies, and 1 other intervention for Chronic Musculoskeletal Pain. Completed, enrolled 3,603 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedOct 28, 2021
Enrollment StartMar 17, 2021
Primary CompletionSep 17, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 4.7 years ago

Interventions

Practitioner-delivered CIH therapiesother

Practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) as received in VHA and community practice settings

Combination of practitioner-delivered and self-care CIH therapiesother

Combination of practitioner-delivered (acupuncture, therapeutic massage, chiropractic care) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies as received in VHA and community practice settings

Self-care CIH therapiesother

Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings