Care Outcomes for Chiropractic Outpatient Veterans

NCT03254719 | Completed Results DMC

• 2 other identifiers: COCOV-Aim #3R34AT008427
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief 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 participants will receive up to 10 weeks of chiropractic care and will complete outcome assessments at weeks 3, 5, 7, and 10 of the study.

Conditions

Low Back Pain; PTSD; Depression; Anxiety

Keywords

Low Back Pain; Chiropractic; Veterans; PTSD; Depression; Anxiety

Outcome Measures

Primary Outcomes (6)

• Duration of Study Recruitment

  As part of the feasibility assessment, the investigators will monitor the amount of time it takes to complete study recruitment and enrollment, and data collection. The investigators will monitor this through a data capture program.

  From date of first participant enrolled to date last participant is enrolled, up to 8 months.

• Diversity of Patient Demographics

  As part of the recruitment plan, investigators are trying to target female and minority veterans. Historically these groups have been underrepresented in veteran research. The investigators will review EHR data for participant demographics.

  Screening through baseline

• Number of Participants Engaged in Use of MyHealthEVet

  As part of the feasibility assessment, investigators will monitor the number of study participants who enroll in and have at least one communication with MyHealthEVet. MyHealthEVet is an online communication tool designed to partner veterans and the veteran's health care team. It provides information on the veteran's health record and health topics as well as allows messaging communication between veterans and health care providers. Usage reports generated by MyHealthEVet will be analyzed to determine number of study participants engaged.

  10 weeks from Baseline

• Acceptability

  Acceptability will be assessed by conducting structured, qualitative exit interviews with participants and providers.

  At Week 10 of the study

• Number of Participants With Reported Adverse Events

  Safety for this study will be assessed by the number of adverse events counted and recorded.

  10 weeks from Baseline

• Percentage of Participants Who Did Not Attend the Initial Chiropractic Visit, Withdrew, or Are Lost to Follow-up

  As part of the feasibility assessment and ability to calculate a sample size for a full scale trial with subgroup analysis, investigators will monitor the percentage of missing data. This will include the percentage of participants who did not attend the initial chiropractic visit and withdraw or are lost to follow-up.

  10 weeks from Baseline

Secondary Outcomes (10)

• Roland Morris Low Back Pain Disability Questionnaire (RMDQ)

  Baseline visit and weeks 5 and 10

• Pain Assessment Screening Tool and Outcomes Registry (PASTOR)

  Baseline visit and weeks 5 and 10

• STarT Back Screening Tool

  Baseline visit and week 10

• Self-Efficacy for Managing Symptoms (SF8a)

  Baseline visit and week 10

• Patient Health Questionnaire (PHQ-9)

  Baseline visit and week 10

Study Arms (1)

Treatment Arm

OTHER

All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.

Other: Study assessments

Interventions

Study assessments OTHER

All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans age 18 years or older
• Self-reported chronic LBP
• Ability to sign informed consent form

You may not qualify if:

• Use of chiropractic care within the past 90 days
• Impaired cognitive ability
• Not a candidate for chiropractic care
• Not able to attend chiropractic appointments
• Identified as at risk for suicide

Sponsors & Collaborators

• Palmer College of Chiropractic: lead
• University of Iowa: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (4)

VA Community Based Outpatient Clinic

Coralville, Iowa, 52241, United States

Location

Palmer Center for Chiropractic Research

Davenport, Iowa, 52803, United States

Location

Iowa City Veterans Affairs Health Care System

Iowa City, Iowa, 52246, United States

Location

The Spine Institute for Quality

Oskaloosa, Iowa, 52577, United States

Location

Related Publications (3)

• Lisi AJ, Salsbury SA, Hawk C, Vining RD, Wallace RB, Branson R, Long CR, Burgo-Black AL, Goertz CM. Chiropractic Integrated Care Pathway for Low Back Pain in Veterans: Results of a Delphi Consensus Process. J Manipulative Physiol Ther. 2018 Feb;41(2):137-148. doi: 10.1016/j.jmpt.2017.10.001.

  PMID: 29482827 RESULT

• Long CR, Salsbury SA, Vining RD, Lisi AJ, Corber L, Twist E, Abrams T, Wallace RB, Goertz CM. Care Outcomes for Chiropractic Outpatient Veterans (COCOV): a single-arm, pragmatic, pilot trial of multimodal chiropractic care for U.S. veterans with chronic low back pain. Pilot Feasibility Stud. 2022 Mar 7;8(1):54. doi: 10.1186/s40814-022-01008-0.

  PMID: 35256010 DERIVED

• Salsbury SA, Twist E, Wallace RB, Vining RD, Goertz CM, Long CR. Care Outcomes for Chiropractic Outpatient Veterans (COCOV): a qualitative study with veteran stakeholders from a pilot trial of multimodal chiropractic care. Pilot Feasibility Stud. 2022 Jan 14;8(1):6. doi: 10.1186/s40814-021-00962-5.

  PMID: 35031072 DERIVED

MeSH Terms

Conditions

Low Back Pain; Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Anna Walden-Cobb
• Organization: Palmer Center for Chiropractic Research

anna.waldencobb@palmer.edu

563-949-0676

Study Officials

• Christine M Goertz, DC, PhD

  The Spine Institute for Quality

  PRINCIPAL INVESTIGATOR

• Cynthia Long, PhD

  Palmer Center for Chiropractic Research (PCCR)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Chiropractic care will be administered by licensed DCs who are current employees of the Iowa City VA Health Care System (ICVAHCS). Participants will receive chiropractic care at a frequency of 1-2 visits per week for a duration up to 10 weeks, with the frequency and duration of care individualized within established VA parameters. For this trial, the minimum treatment dose is 1 visit to the DC, while the maximum treatment dose is 12 visits.

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: August 18, 2017
• Study Start: February 19, 2018
• Primary Completion: November 5, 2018
• Study Completion: November 5, 2018
• Last Updated: May 18, 2020
• Results First Posted: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)