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NCT05097521 · ClinicalTrials.gov registry record
Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health
A clinical trial of Chronic Musculoskeletal Pain, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- 3,726
- Enrollment target
- 2
- Study locations
NCT05097521: Completed study of Chronic Musculoskeletal Pain, sponsored by VA Office of Research and Development.
NCT05097521 is a study of Chronic Musculoskeletal Pain that has completed, run by VA Office of Research and Development. The registered enrollment target is 3,726 participants, above the 149-participant average among 13 other Chronic Musculoskeletal Pain trials with a reported enrollment target (2401% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05097521, a study of Chronic Musculoskeletal Pain, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- 3,726 participants
- Enrollment target
- 2
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 3,726 participants |
| Start Date | 2021-03-17 |
| Est. Completion | 2023-09-17 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 3,726 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 149-participant average among 13 other Chronic Musculoskeletal Pain trials with a reported enrollment target (2401% higher). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
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.
NCT05097521 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Washington.
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.
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).
Who is sponsoring clinical trial NCT05097521?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
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