Clinical trial NCT03254719: Care Outcomes for Chiropractic Outpatient Veterans
Official title: Care Outcomes for Chiropractic Outpatient Veterans Aim 3-pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
PTSD
Depression
Anxiety
Keywords: Low Back Pain
Chiropractic
Veterans
PTSD
Depression
Anxiety
Lead sponsor: Palmer College of Chiropractic
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2017-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: The coinciding problems of chronic pain and mental illness are of great concern for patients seeking care within the Department of Veterans Affairs (VA) healthcare facilities. Of the 5.7 million veterans treated in VA facilities in 2012, more than half reported chronic pain syndromes, including chronic low back pain (cLBP). Veterans also experience many mental health comorbidities, such as depression, anxiety, post-traumatic stress disorder (PTSD), and substance abuse. Veterans in pain are often managed using prescription drugs, including opioids, psychotropic medications, and sleep agents. Non-pharmacological treatments for chronic pain, which also may provide relief of mental health symptoms, may be welcomed complementary therapies for veterans suffering from these conditions.

Patients with musculoskeletal (MSK) pain and pain at multiple locations often report depression, anxiety and other mental health symptoms. Chronic pain may perpetuate mental health comorbidity as these conditions share common pathophysiological pathways. Research has shown that the non-specific effects of empathetic doctor communication and therapeutic alliance improves clinical outcomes. The investigators hypothesize that chiropractic care offers relief for pain and mental health symptoms through the direct effects of treatment-focused chiropractic manipulative therapy (CMT), as well as through the indirect, non-specific effects of the team-based relationship with the clinician.

However, chiropractic care is not delivered in isolation from other treatments within the VA. Thus, the investigators will test a feasible, effective, patient-centered, guideline-based, integrative care model that integrates chiropractic into VA Patient Aligned Care Teams (PACTs). This integrative care pathway will involve primary care providers, mental health professionals, and doctors of chiropractic (DCs) engaged in the treatment of veterans with cLBP, with or without mental health comorbidity. While DCs are providing services within VA in increasing numbers over the past 13 years, as with any new service, adoption and appropriate placement faces challenges. Many VA providers may know little about the clinical approaches used by DCs. Similarly, DCs may not be fully aware of the processes involved in the delivery of primary care services within VA or the healthcare needs of veterans with mental illness. The purpose of this pilot clinical trial is to evaluate the feasibility, safety and patient perceptions of an integrative care pathway, developed through a consensus-based process, for the coordinated care for VA patients with cLBP and mental health comorbidity.

As this is a pragmatic trial, chiropractic care will consist of usual chiropractic procedures for the management chronic low back pain (cLBP). Treatment approaches will be based on clinical evaluation, which may include diagnostic testing, to determine a working diagnosis, rule out pathology, and/or to screen for conditions requiring referral or other co-management. The investigators anticipate that chiropractic care often will include some form of chiropractic manipulative therapy (CMT). DCs will likely also recommend rehabilitative exercise, stretching, or nutritional and lifestyle advice based upon clinical findings and patient goals/preferences. The investigators will evaluate treatments through electronic health records (EHR) data abstraction following completion of chiropractic care at Week 10. As per typical VA care, DCs will monitor the participant's health status throughout the trial and initiate referrals as clinically indicated. Referrals to primary care and mental health providers will be consistent with the chiropractic integrated care pathway developed during a prior phase of the study. The investigators anticipate the most common communication and referral methods will occur through note-review and countersign procedures, which are already established among VA providers using the VA electronic health record, but may also occur in person or via phone conversations. Chiropractic care will be administered by licensed DCs who are current employees of the Iowa City VA Health Care System (ICVAHCS).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Duration of Study Recruitment
timeFrame: From date of first participant enrolled to date last participant is enrolled, up to 8 months.
measure: Diversity of Patient Demographics
timeFrame: Screening through baseline
measure: Number of Participants Engaged in Use of MyHealthEVet
timeFrame: 10 weeks from Baseline
measure: Acceptability
timeFrame: At Week 10 of the study
measure: Number of Participants With Reported Adverse Events
timeFrame: 10 weeks from Baseline
measure: Percentage of Participants Who Did Not Attend the Initial Chiropractic Visit, Withdrew, or Are Lost to Follow-up
timeFrame: 10 weeks from Baseline
Secondary outcomes:
measure: Roland Morris Low Back Pain Disability Questionnaire (RMDQ)
timeFrame: Baseline visit and weeks 5 and 10
measure: Pain Assessment Screening Tool and Outcomes Registry (PASTOR)
timeFrame: Baseline visit and weeks 5 and 10
measure: STarT Back Screening Tool
timeFrame: Baseline visit and week 10
measure: Self-Efficacy for Managing Symptoms (SF8a)
timeFrame: Baseline visit and week 10
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline visit and week 10
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline visit and week 10
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Baseline visit and week 10
measure: PTSD Checklist-Civilian (PCL-C)
timeFrame: Baseline visit and week 10
measure: Healing Encounters and Attitudes Lists (HEAL)
timeFrame: After the initial chiropractic visit
measure: Pain, Enjoyment, and General Activity (PEG)
timeFrame: Week 3 and Week 7
Other outcomes:
Locations:
city: Coralville
country: United States
facility: VA Community Based Outpatient Clinic
state: Iowa
city: Davenport
country: United States
facility: Palmer Center for Chiropractic Research
state: Iowa
city: Iowa City
country: United States
facility: Iowa City Veterans Affairs Health Care System
state: Iowa
city: Oskaloosa
country: United States
facility: The Spine Institute for Quality
state: Iowa
Study officials:
affiliation: The Spine Institute for Quality
name: Christine M Goertz, DC, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palmer Center for Chiropractic Research (PCCR)
name: Cynthia Long, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.