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NCT03254719 · ClinicalTrials.gov registry record · NA
Care Outcomes for Chiropractic Outpatient Veterans
A NA study of Depression and Anxiety, sponsored by Palmer College of Chiropractic.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 4
- Study locations
NCT03254719 is a NA study of Depression and Anxiety that has completed, run by Palmer College of Chiropractic. The registered enrollment target is 40 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 1 state.
The verdict
NCT03254719, a NA study of Depression and Anxiety, has completed, sponsored by Palmer College of Chiropractic.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 4
- Study locations
Study Summary
The primary objectives of this pilot trial are to evaluate the feasibility, safety and acceptability of an integrative care pathway that includes chiropractic care, for the coordinated care for Veterans Administration (VA) patients with chronic low back pain (cLBP), with an emphasis on those with mental health comorbidity, in preparation for the conduct of an appropriately powered multi-site randomized controlled trial (RCT). The secondary objectives are to collect study outcomes at the baseline visit (BV) and at weeks 3, 5, 7, and 10 to: 1) assess the success of collecting outcomes; 2) determine the outcome measures to use in a future RCT; and 3) determine preliminary intervention effect sizes and variability to aid in sample size determination for a future RCT. The investigators hypothesize that chiropractic care offers relief for pain and mental health symptoms through the direct effects of treatment-focused CMT, as well as through the indirect, non-specific effects of the team-based relationship with the clinician. This pilot study is a single-arm trial. All participants will be asked to complete study outcomes which include the Roland Morris Disability Questionnaire (RMDQ), LBP intensity and interference as measured by the Defense and Veterans Pain Rating Scale (DVPRS), as well as the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale (GAD-7), Alcohol Use Disorders Identification Test (AUDIT), Post-traumatic Stress Disorder Checklist-Civilian Version (PLC-C), self-care behaviors, Keele Start Back Screening Tool (STarT Back), Healing Encounters and Attitudes Lists (HEAL), Expectations for Complementary and Integrative Treatments Questionnaire (EXPECT), and Pain Intensity, Enjoyment of Life, General Activity Assessment Tool (PEG) questionnaires, and the Pain Assessment Screening Tool and Outcomes Registry (PASTOR) assessment, which includes measures of pain, disability, mental health, quality of life enjoyment and satisfaction. All
Conditions Studied
Interventions
- OTHER Study assessments
Study Locations (4)
Iowa
- VA Community Based Outpatient Clinic - Coralville
- Palmer Center for Chiropractic Research - Davenport
- Iowa City Veterans Affairs Health Care System - Iowa City
- The Spine Institute for Quality - Oskaloosa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-02-19 |
| Est. Completion | 2018-11-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03254719
The ClinicalTrials.gov registry entry for NCT03254719 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (95% lower). The listed sponsor is Palmer College of Chiropractic, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Study assessments is the first listed.
NCT03254719 reports 4 study locations spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT03254719 about?
NCT03254719 is a clinical study titled "Care Outcomes for Chiropractic Outpatient Veterans". The primary objectives of this pilot trial are to evaluate the feasibility, safety and acceptability of an integrative care pathway that includes chiropractic care, for the coordinated care for Veterans Administration (VA) patients with chronic low back pain (cLBP), with an emphasis on those with me...
What is the current status of trial NCT03254719?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2018-02-19. Estimated completion is 2018-11-05.
What conditions does trial NCT03254719 study?
This clinical trial studies the following conditions: Depression, Anxiety, PTSD, Low Back Pain.
What interventions are being tested in trial NCT03254719?
The interventions under investigation include: Study assessments (OTHER).
Who is sponsoring clinical trial NCT03254719?
This trial is sponsored by Palmer College of Chiropractic, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03254719 being conducted?
This trial has 4 study locations across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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