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COMPLETED

Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health

NCT05097521 · View on ClinicalTrials.gov ↗

Study 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 using 18 VA medical centers. Those facilities received funding as part of the Comprehensive Addiction and Recovery Act to expand availability of CIH therapies. 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, and self-care therapies include Tai Chi/qigong, yoga and meditation. The primary outcomes are improvement in pain severity and pain interference, using the Brief Pain Inventory (BPI), 6 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.

Interventions

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

Study Locations (2)

California

  • VA Greater Los Angeles Healthcare System, Sepulveda, CA — Sepulveda

Washington

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle

Trial Details

FieldValue
Enrollment Target 3,726 participants
Start Date 2021-03-17
Est. Completion 2023-09-17

Sponsor

VA Office of Research and Development

1,863 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05097521

The ClinicalTrials.gov registry entry for NCT05097521 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,726 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Musculoskeletal Pain appearing as the primary indexed condition, and to 3 interventions — of which Practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) as received in VHA and community practice settings is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05097521 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05097521 about?

NCT05097521 is a clinical study titled "Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health". 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 musculoskele...

What is the current status of trial NCT05097521?

This trial is currently completed. The enrollment target is 3,726 participants. The study started on 2021-03-17. Estimated completion is 2023-09-17.

What conditions does trial NCT05097521 study?

This clinical trial studies the following conditions: Chronic Musculoskeletal Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05097521?

The interventions under investigation include: Practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) as received in VHA and community practice settings (OTHER), Self-care CIH therapies (yoga, Tai Chi/Qigong , meditation) as received in VHA and community practice settings (OTHER), Combination of practitioner-delivered and self-care CIH therapies (described above) as received in VHA and community practice settings (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05097521?

This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05097521 being conducted?

This trial has 2 study locations across California, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial