Trial Outcomes & Findings for Care Outcomes for Chiropractic Outpatient Veterans (NCT NCT03254719)
NCT ID: NCT03254719
Last Updated: 2020-05-18
Results Overview
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.
COMPLETED
NA
40 participants
From date of first participant enrolled to date last participant is enrolled, up to 8 months.
2020-05-18
Participant Flow
Participant milestones
| Measure |
Treatment Arm
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.
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.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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40
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Care Outcomes for Chiropractic Outpatient Veterans
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=40 Participants
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.
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.
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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29 Participants
n=5 Participants
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Age, Categorical
>=65 years
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11 Participants
n=5 Participants
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Age, Continuous
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53.3 years
STANDARD_DEVIATION 15.1 • n=5 Participants
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Sex: Female, Male
Female
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9 Participants
n=5 Participants
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Sex: Female, Male
Male
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31 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · Unknown
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · White
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36 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · Multi-racial
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · Declined to Answer
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
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38 Participants
n=5 Participants
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Region of Enrollment
United States
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40 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment Arm
n=40 Participants
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.
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.
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Duration of Study Recruitment
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6 months
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PRIMARY outcome
Timeframe: Screening through baselineAs 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.
Outcome measures
| Measure |
Treatment Arm
n=40 Participants
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.
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.
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|---|---|
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Diversity of Patient Demographics
Hispanic or Latino
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2 Participants
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Diversity of Patient Demographics
Male
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31 Participants
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Diversity of Patient Demographics
18-35 years
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6 Participants
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Diversity of Patient Demographics
36-54 years
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16 Participants
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Diversity of Patient Demographics
Multi-racial
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1 Participants
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Diversity of Patient Demographics
White
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36 Participants
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Diversity of Patient Demographics
Other or unspecified
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3 Participants
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Diversity of Patient Demographics
55+ years
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18 Participants
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PRIMARY outcome
Timeframe: 10 weeks from BaselineAs 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.
Outcome measures
| Measure |
Treatment Arm
n=40 Participants
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.
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.
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Number of Participants Engaged in Use of MyHealthEVet
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15 Participants
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PRIMARY outcome
Timeframe: At Week 10 of the studyPopulation: Acceptability of chiropractic service delivery as viewed by those veterans who were interviewed.
Acceptability will be assessed by conducting structured, qualitative exit interviews with participants and providers.
Outcome measures
| Measure |
Treatment Arm
n=24 Participants
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.
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.
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Acceptability
Viewed as Positive
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10 Participants
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Acceptability
Viewed as Mixed Positive/Negative
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9 Participants
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Acceptability
Viewed as Negative
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5 Participants
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PRIMARY outcome
Timeframe: 10 weeks from BaselineSafety for this study will be assessed by the number of adverse events counted and recorded.
Outcome measures
| Measure |
Treatment Arm
n=40 Participants
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.
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.
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Number of Participants With Reported Adverse Events
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6 Participants
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PRIMARY outcome
Timeframe: 10 weeks from BaselineAs 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.
Outcome measures
| Measure |
Treatment Arm
n=40 Participants
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.
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.
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Percentage of Participants Who Did Not Attend the Initial Chiropractic Visit, Withdrew, or Are Lost to Follow-up
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8 Participants
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SECONDARY outcome
Timeframe: Baseline visit and weeks 5 and 10The 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)
Outcome measures
| Measure |
Treatment Arm
n=40 Participants
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.
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.
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Roland Morris Low Back Pain Disability Questionnaire (RMDQ)
Baseline
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12.9 score on a scale
Standard Deviation 5.1
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Roland Morris Low Back Pain Disability Questionnaire (RMDQ)
Week 5
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10.2 score on a scale
Standard Deviation 5.5
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Roland Morris Low Back Pain Disability Questionnaire (RMDQ)
Week 10
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9.6 score on a scale
Standard Deviation 6.2
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SECONDARY outcome
Timeframe: Baseline visit and weeks 5 and 10Population: There are missing data when a participant was lost to follow-up or chose not to complete an item.
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.
Outcome measures
| Measure |
Treatment Arm
n=40 Participants
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.
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.
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Pain Assessment Screening Tool and Outcomes Registry (PASTOR)
Worst Pain, Baseline
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6.4 score on a scale
Standard Deviation 1.7
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Pain Assessment Screening Tool and Outcomes Registry (PASTOR)
Worst Pain, Week 5
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5.7 score on a scale
Standard Deviation 2.0
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Pain Assessment Screening Tool and Outcomes Registry (PASTOR)
Worst Pain, Week 10
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5.3 score on a scale
Standard Deviation 2.2
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Pain Assessment Screening Tool and Outcomes Registry (PASTOR)
Average Pain, Baseline
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5.4 score on a scale
Standard Deviation 1.4
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Pain Assessment Screening Tool and Outcomes Registry (PASTOR)
Average Pain, Week 5
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4.8 score on a scale
Standard Deviation 1.8
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Pain Assessment Screening Tool and Outcomes Registry (PASTOR)
Average Pain, Week 10
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3.9 score on a scale
Standard Deviation 2.0
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SECONDARY outcome
Timeframe: Baseline visit and week 10This 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).
Outcome measures
| Measure |
Treatment Arm
n=40 Participants
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.
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.
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STarT Back Screening Tool
Baseline · Low Risk
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2 Participants
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STarT Back Screening Tool
Baseline · Medium Risk
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17 Participants
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STarT Back Screening Tool
Baseline · High Risk
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13 Participants
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STarT Back Screening Tool
Baseline · Missing
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8 Participants
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STarT Back Screening Tool
Week 10 · Low Risk
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9 Participants
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STarT Back Screening Tool
Week 10 · Medium Risk
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12 Participants
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STarT Back Screening Tool
Week 10 · High Risk
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7 Participants
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STarT Back Screening Tool
Week 10 · Missing
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12 Participants
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SECONDARY outcome
Timeframe: Baseline visit and week 10Population: PROMIS - Self-Efficacy for Managing Symptoms - T score at Baseline and Week 10 follow-up.
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).
Outcome measures
| Measure |
Treatment Arm
n=32 Participants
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.
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.
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Self-Efficacy for Managing Symptoms (SF8a)
Baseline
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41.6 score on a scale
Standard Deviation 6.4
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Self-Efficacy for Managing Symptoms (SF8a)
Week 10
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43.5 score on a scale
Standard Deviation 8.2
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SECONDARY outcome
Timeframe: Baseline visit and week 10This 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.
Outcome measures
| Measure |
Treatment Arm
n=40 Participants
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.
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.
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Patient Health Questionnaire (PHQ-9)
Baseline
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9.7 score on a scale
Standard Deviation 5.6
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Patient Health Questionnaire (PHQ-9)
Week 10
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8.6 score on a scale
Standard Deviation 5.8
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SECONDARY outcome
Timeframe: Baseline visit and week 10This 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.
Outcome measures
| Measure |
Treatment Arm
n=40 Participants
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.
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.
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Generalized Anxiety Disorder-7 (GAD-7)
Baseline
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7.7 score on a scale
Standard Deviation 5.6
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Generalized Anxiety Disorder-7 (GAD-7)
Week 10
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6.8 score on a scale
Standard Deviation 5.3
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SECONDARY outcome
Timeframe: Baseline visit and week 10Developed 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).
Outcome measures
| Measure |
Treatment Arm
n=40 Participants
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.
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.
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Alcohol Use Disorders Identification Test (AUDIT)
Week 10
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1.7 score on a scale
Standard Deviation 1.9
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Alcohol Use Disorders Identification Test (AUDIT)
Baseline
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2.2 score on a scale
Standard Deviation 2.8
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SECONDARY outcome
Timeframe: Baseline visit and week 10This 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).
Outcome measures
| Measure |
Treatment Arm
n=40 Participants
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.
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.
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PTSD Checklist-Civilian (PCL-C)
Baseline
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40.3 score on a scale
Standard Deviation 18.1
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PTSD Checklist-Civilian (PCL-C)
Week 10
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40.1 score on a scale
Standard Deviation 19.3
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SECONDARY outcome
Timeframe: After the initial chiropractic visitHEAL 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).
Outcome measures
| Measure |
Treatment Arm
n=29 Participants
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.
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.
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Healing Encounters and Attitudes Lists (HEAL)
Patient-Provider Connection - T-Score
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60.9 score on a scale
Standard Deviation 10.6
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Healing Encounters and Attitudes Lists (HEAL)
Healthcare Environment - T-Score
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54.4 score on a scale
Standard Deviation 8.4
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Healing Encounters and Attitudes Lists (HEAL)
Treatment Expectancy - T-Score
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54.6 score on a scale
Standard Deviation 11.5
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Healing Encounters and Attitudes Lists (HEAL)
Positive Outlook - T-Score
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52.0 score on a scale
Standard Deviation 10.4
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Healing Encounters and Attitudes Lists (HEAL)
Spirituality - T-Score
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50.9 score on a scale
Standard Deviation 13.3
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Healing Encounters and Attitudes Lists (HEAL)
Attitudes toward CAM - T-Score
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56.0 score on a scale
Standard Deviation 9.6
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SECONDARY outcome
Timeframe: Week 3 and Week 7The 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).
Outcome measures
| Measure |
Treatment Arm
n=35 Participants
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.
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.
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|---|---|
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Pain, Enjoyment, and General Activity (PEG)
Overall PEG-3 Score, Week 3
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5.2 score on a scale
Standard Deviation 2.0
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Pain, Enjoyment, and General Activity (PEG)
Overall PEG-3 Score, Week 7
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4.7 score on a scale
Standard Deviation 2.3
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Pain, Enjoyment, and General Activity (PEG)
Average pain, Week 3
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5.1 score on a scale
Standard Deviation 2.0
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Pain, Enjoyment, and General Activity (PEG)
Average pain, Week 7
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4.8 score on a scale
Standard Deviation 2.0
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Pain, Enjoyment, and General Activity (PEG)
Enjoyment of Life Pain Interference, Week 3
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5.3 score on a scale
Standard Deviation 2.2
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Pain, Enjoyment, and General Activity (PEG)
Enjoyment of Life Pain Interference, Week 7
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4.7 score on a scale
Standard Deviation 2.5
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Pain, Enjoyment, and General Activity (PEG)
General Activity Pain Interference, Week 3
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5.2 score on a scale
Standard Deviation 2.2
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Pain, Enjoyment, and General Activity (PEG)
General Activity Pain Interference, Week 7
|
4.7 score on a scale
Standard Deviation 2.7
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Adverse Events
Treatment Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Arm
n=40 participants at risk
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.
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.
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|---|---|
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Musculoskeletal and connective tissue disorders
Muscle pain
|
12.5%
5/40 • Number of events 5 • Baseline to 10 weeks.
An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.
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Additional Information
Dr. Anna Walden-Cobb
Palmer Center for Chiropractic Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place