Care Outcomes for Chiropractic Outpatient Veterans (COCOV)
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|ClinicalTrials.gov Identifier: NCT03254719|
Recruitment Status : Completed
First Posted : August 18, 2017
Results First Posted : May 18, 2020
Last Update Posted : May 18, 2020
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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.
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain PTSD Depression Anxiety||Other: Study assessments||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Care Outcomes for Chiropractic Outpatient Veterans Aim 3-pilot Trial|
|Actual Study Start Date :||February 19, 2018|
|Actual Primary Completion Date :||November 5, 2018|
|Actual Study Completion Date :||November 5, 2018|
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
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.
- Duration of Study Recruitment [ Time Frame: From date of first participant enrolled to date last participant is enrolled, up to 8 months. ]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.
- Diversity of Patient Demographics [ Time Frame: Screening through baseline ]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.
- Number of Participants Engaged in Use of MyHealthEVet [ Time Frame: 10 weeks from Baseline ]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.
- Acceptability [ Time Frame: At Week 10 of the study ]Acceptability will be assessed by conducting structured, qualitative exit interviews with participants and providers.
- Number of Participants With Reported Adverse Events [ Time Frame: 10 weeks from Baseline ]Safety for this study will be assessed by the number of adverse events counted and recorded.
- Percentage of Participants Who Did Not Attend the Initial Chiropractic Visit, Withdrew, or Are Lost to Follow-up [ Time Frame: 10 weeks from Baseline ]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.
- Roland Morris Low Back Pain Disability Questionnaire (RMDQ) [ Time Frame: Baseline visit and weeks 5 and 10 ]The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. (0-24, 0=No Disability, 24=Severe Disability)
- Pain Assessment Screening Tool and Outcomes Registry (PASTOR) [ Time Frame: Baseline visit and weeks 5 and 10 ]PASTOR is an on-line data collection tool based on the NIH Patient Reported Outcomes Measurement Information System (PROMIS) and adopted by the DoD/VA Pain Management Task Force. Specific measures include the Defense & Veterans Pain Rating Scale (DVPRS), an enhanced 11-item (total range 0-10, 0=no pain, 10=worst pain) numeric rating scale (NRS) that improves on standard pain NRS by including a Faces Rating Scale component; 'traffic light' color-coding system to delineate mild, moderate and severe pain; and word descriptors, paired with 4, 0-10 NRS items to quantify the impact of pain on general activity, sleep, mood, and stress. PASTOR incorporates PROMIS measures for mental health conditions (PTSD, depression, anxiety, anger, and alcohol use), physical and social function, fatigue, and pain interference with daily activities to provide graphical representation of improvements or declines in patient status that are compared to matched US samples on age, race/ethnicity and sex.
- STarT Back Screening Tool [ Time Frame: Baseline visit and week 10 ]This is a 9-item, validated tool developed by Keele University to be used as a screening tool for patients with low back pain. It stratifies patients based on their prognosis of persistent disabling symptoms and allows practitioners to group patients into 3 categories (low, medium, or high risk of poor outcome).
- Self-Efficacy for Managing Symptoms (SF8a) [ Time Frame: Baseline visit and week 10 ]Developed by the Patient-Reported Outcomes Measurement Information System (PROMIS), this 8-item, self-reported tool will assess a person's level of confidence to manage/control symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities. Each question usually has five response options ranging in value from 1 to 5. The total raw score for a measure is converted to into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured. For example, a T-score of 55 on the PROMIS Self-Efficacy for Managing Symptoms indicates that the respondent has greater self-efficacy for managing their symptoms than the general chronic condition population (half a standard deviation higher).
- Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline visit and week 10 ]This instrument is self-reported with nine items and will be used to assess depressive disorder. Total scores range from 0 to 27 with a score of 10-14 considered to be in the moderate range (0-27, 0=No Depression, 27=Severe Depression). It has been tested in primary care settings and has a test-retest reliability of 0.81 to 0.96.
- Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Baseline visit and week 10 ]This instrument is self-reported with seven items and will be used to assess generalized anxiety disorder. At a cut off score of 10 (0-21, 0=No Anxiety Disorder, 21=Severe Anxiety Disorder), it has a sensitivity of 0.89 and specificity of 0.82 for identifying patients with GAD in primary care settings.
- Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Baseline visit and week 10 ]Developed by the World Health Organization (WHO), this 10-item screening questionnaire determines harmful or hazardous consumption of alcohol, correctly classifying 95% of people as having a clinical diagnosis of an alcohol abuse disorder (0-12, 0=No Alcohol Use).
- PTSD Checklist-Civilian (PCL-C) [ Time Frame: Baseline visit and week 10 ]This 17-item, self-reported instrument will assess PTSD. A total severity score is determined by summing scores from each of 17 items. A change of 5-10 points represents the minimum threshold for determining treatment response; a 10-20 point change represents a clinically significant change in PTSD symptom severity (17-85, 17=Not at all Severe PTSD Symptoms, 85=Extremely Severe PTSD Symptoms).
- Healing Encounters and Attitudes Lists (HEAL) [ Time Frame: After the initial chiropractic visit ]HEAL is a validated item-bank comprised of 6 domains developed through the Patient Reported Outcomes Measurement Information System (PROMIS) methodology. Investigators will use HEAL to assess nonspecific factors known to influence patient outcomes, including perceptions of the patient-provider connection, healthcare environment, treatment expectancy, spirituality, positive or negative outlook, and attitudes toward complementary and alternative medicine (CAM). A higher T-score represents more of the concept being measured. A T-score of 50 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more positive perception. For example, a T-score of 55 on Patient-Provider Connection indicates that the respondent has a more positive perception toward the patient-provider connection than the general chronic condition population (half a standard deviation higher).
- Pain, Enjoyment, and General Activity (PEG) [ Time Frame: Week 3 and Week 7 ]The PEG is a 3-item tool to improve assessment and monitoring of chronic pain. The overall PEG-3 score ranges from 0-10 with 10 indicating more pain, more interference with enjoyment of life, and more interference with general activity. Questions assess average pain intensity (P) (AVERAGE pain in past week: 0-10, 0= No Pain, 10=Pain as bad as you can imagine), interference with enjoyment of life (E), and interference with general activity (G) (In past week, how pain interfered with...(0-10, 0=Does not interfere, 10=Completely interferes).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Veterans age 18 years or older
- Self-reported chronic LBP
- Ability to sign informed consent form
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254719
|United States, Iowa|
|VA Community Based Outpatient Clinic|
|Coralville, Iowa, United States, 52241|
|Palmer Center for Chiropractic Research|
|Davenport, Iowa, United States, 52803|
|Iowa City Veterans Affairs Health Care System|
|Iowa City, Iowa, United States, 52246|
|The Spine Institute for Quality|
|Oskaloosa, Iowa, United States, 52577|
|Principal Investigator:||Christine M Goertz, DC, PhD||The Spine Institute for Quality|
|Principal Investigator:||Cynthia Long, PhD||Palmer Center for Chiropractic Research (PCCR)|
Documents provided by Palmer College of Chiropractic:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Palmer College of Chiropractic|
|Other Study ID Numbers:||
R34AT008427 ( U.S. NIH Grant/Contract )
|First Posted:||August 18, 2017 Key Record Dates|
|Results First Posted:||May 18, 2020|
|Last Update Posted:||May 18, 2020|
|Last Verified:||May 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Feasibility/pilot study|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Low Back Pain
Low Back Pain