Low Back Pain, Patient Acceptance of Health Care, Veterans Health
Conditions
Keywords
chronic, pain management, manipulation, chiropractic
Brief summary
This study evaluates how Veterans with chronic low back pain (cLBP) respond to varying doses of chiropractic therapy and how health services utilization are impacted as a result. There are 2 phases in this study. In Phase 1, half of participants will be randomized to receive a low dose (1-5 visits) of chiropractic care for 10 weeks, while the other half will be randomized to receive a higher dose (8-12 visits) for 10 weeks. At the end of Phase 1, participants in each group will be randomized again to receive either chronic chiropractic pain management (CCPM) (1 scheduled chiropractic visit per month x 10 months) or no CCPM for 10 months.
Detailed description
The combination of chronic low back pain (cLBP) and high medication use negatively impacts Veterans' work productivity and quality of life, and generates substantial risk for long-term disability and opioid addiction. Although non-pharmacological therapies, such as those commonly used by doctors of chiropractic (DCs), are recommended by recent guidelines for treatment of cLBP, the optimal patterns of chiropractic use, clinical impact of chiropractic treatment on other health services utilization, and long-term effectiveness of chiropractic care is unknown. This is a pragmatic, parallel groups, multisite randomized trial. Veterans with cLBP are randomly allocated to undergo a course of a low dose (1-5 visits) or a higher dose (8-12 visits) of multimodal, evidence-based chiropractic care for 10 weeks (Phase 1). The investigators hypothesize that a higher dose (8-12 visits) of chiropractic care will be more effective in improving function and reducing pain intensity and pain-related interference in Veterans with cLBP compared to a low dose (1-5 visits). After Phase 1, participants within each treatment arm will be randomly allocated again to receive either chronic chiropractic pain management (CCPM) consisting of scheduled monthly chiropractic care or no CCPM for 10 months. The investigators hypothesize that CCPM (1 scheduled chiropractic visit per month x 10 months) will result in improved function, and reduced pain intensity, pain-related interference, and average number of days per week with low back pain (LBP) in Veterans with cLBP compared to no CCPM. This study will also evaluate the impact of CCPM on health services outcomes compared to no CCPM. Evaluation of health services utilization at 52 weeks will include use of prescription medications, including opioids, referrals and number of visits to other healthcare professionals or service lines (physical therapy, injections, surgery, etc.), and hospitalizations for any cause and for cLBP. Finally, the investigators will evaluate patient and clinician perceptions of non-specific treatment factors, effectiveness of study interventions, and impact of the varying doses of standard chiropractic care and the CCPM on clinical outcomes across 4 VA facilities using a mixed method, process evaluation approach.
Interventions
OTHERChiropractic Care
Chiropractic interventions: 1. Patient education. 2. Passive interventions, such as spinal manipulation and myofascial therapies which include thrust type (high velocity-low amplitude) spinal manipulation for the low back, non-thrust manipulation (joint mobilization), and use of manually held instruments, such as an Activator. Myofascial therapies are also commonly used, such as myofascial release and trigger point therapy. 3. Transitional interventions, such as therapeutic exercise. 4. Recommendations for active interventions, such as general exercise and mind-body therapies. 5. Self-management advice, which refers to advice given to build the capacity of a person to self-monitor, control, and/or reduce the impact of a condition over time.
Sponsors
Palmer College of Chiropractic
Yale University
University of Iowa
Dartmouth College
VA Connecticut Healthcare System
Minneapolis Veterans Affairs Medical Center
Iowa City VA Health Care System
VA Greater Los Angeles Healthcare System
National Center for Complementary and Integrative Health (NCCIH)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Doctors of Chiropractic (DCs), site study coordinators (SCs), participants and interviewers will not be blinded to treatment group assignment; DCs will not see research outcome measures; statisticians will be blinded to treatment group assignment during data analysis; and research personnel conducting Computerized Adaptive Testing Interviews (CATIs) will be blinded to study group.
Intervention model description
This pragmatic, parallel groups, multisite randomized trial will include Veterans with cLBP who will be randomly allocated to undergo a course of a low dose (1-5 visits) or a higher dose (8-12 visits) of multimodal, evidence-based chiropractic care for 10 weeks (Phase 1). Group allocation will occur through a 1:1 ratio by a predetermined, computer-generated, restricted randomization scheme with random block sizes, stratified by site and sex. After Phase 1, participants within each treatment arm will be randomly allocated again to receive either chiropractic chronic pain management (CCPM) consisting of scheduled monthly chiropractic care or no CCPM for 10 months. This second group allocation will also occur through a 1:1 ratio to Phase 2 within low dose or higher dose in Phase 1 by a predetermined, computer-generated, restricted randomization scheme with random block sizes, stratified by site and sex.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veterans aged ≥ 18 years * Self-reported cLBP * Has low back related pain and disability * Able to comprehend study details without need for a proxy * Diagnostic confirmation of neuromusculoskeletal LBP * Willing and able to attend up to 1 year of outpatient chiropractic visits
Exclusion criteria
* Any condition prohibiting or contraindicating chiropractic care * Inability to complete outcomes and/or provide informed consent as determined by the site SC during the consent process * Established plans to move within 3 months * Under active chiropractic care * No phone * No email address * Participating in another study investigating treatment(s) for pain * Current or planned hospice care * Current or planned pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Meaningful Improvement in Back-Related Disability From Baseline to Week 10 | Baseline to Week 10 | Proportion of participants achieving a clinically meaningful improvement in low back-related disability, defined as ≥30% relative improvement from baseline to 10 weeks in the Roland Morris Disability Questionnaire (RMDQ; range 0-24, higher scores indicate greater disability). |
| Back-Related Disability Change From Baseline to Week 52 (RMDQ) | Baseline to Week 52 | Back-related disability was measured using the Roland Morris Disability Questionnaire (RMDQ), a 24-item scale with scores ranging from 0 to 24. Higher scores indicate greater disability (worse outcome), and lower scores indicate less disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Days Per Week With Low Back Pain at Week 10 | Week 10 | Self-reported number of days per week (range 0-7) with low back pain during the prior week. Higher values indicate more frequent pain (worse outcome), and lower values indicate fewer days with pain. |
| Low Back Pain Intensity Change From Baseline to Week 52 | Baseline to Week 52 | Low back pain intensity was measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 = no pain and 10 = worst pain imaginable. Higher scores indicate greater pain intensity (worse outcome), and lower scores indicate less pain. |
| PEG Pain Severity Change From Baseline to Week 52 | Baseline to Week 52 | PEG (Pain, Enjoyment of life, General activity) scale assessing pain intensity and interference. Scores range from 0 to 10 (mean of 3 items). Higher scores indicate worse pain and greater interference; lower scores indicate less pain and better function. |
| Physical and Social Health Change From Baseline to Week 52 (PROMIS) | Baseline to Week 52 | PROMIS (Patient-Reported Outcomes Measurement Information System) domains assessed using standardized T-scores (mean=50, SD=10; range \~20-80). A T-score of 50 represents the population mean; scores 10 points above or below represent one standard deviation. Higher scores indicate better outcomes for Global Physical Health, Social Roles Satisfaction, and Global Mental Health. For Pain Interference, Fatigue, and Sleep Disturbance, higher scores indicate worse symptoms. Domains are scored separately. |
| Average Number of Days Per Week With Low Back Pain at Week 52 | Week 52 | Self-reported number of days per week (range 0-7) with low back pain during the prior week. Higher values indicate more frequent pain (worse outcome), and lower values indicate fewer days with pain. |
| Low Back Pain Intensity Change From Baseline to Week 10 | Baseline to Week 10 | Low back pain intensity was measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 = no pain and 10 = worst pain imaginable. Higher scores indicate greater pain intensity (worse outcome), and lower scores indicate less pain. |
| Physical and Social Health Change From Baseline to Week 10 (PROMIS) | Baseline to Week 10 | PROMIS (Patient-Reported Outcomes Measurement Information System) domains assessed using standardized T-scores (mean=50, SD=10; range \~20-80). A T-score of 50 represents the population mean; scores 10 points above or below represent one standard deviation. Higher scores indicate better outcomes for Global Physical Health, Social Roles Satisfaction, and Global Mental Health. For Pain Interference, Fatigue, and Sleep Disturbance, higher scores indicate worse symptoms. Domains are scored separately. |
| PEG Pain Severity Change From Baseline to Week 10 | Baseline to Week 10 | PEG (Pain, Enjoyment of life, General activity) scale assessing pain intensity and interference. Scores range from 0 to 10 (mean of 3 items). Higher scores indicate worse pain and greater interference; lower scores indicate less pain and better function. |
| Global Mental Health: Physical and Social Health Change From Baseline to Week 10 (PROMIS) | Baseline to Week 10 | PROMIS Global Mental Health assessed using standardized T-scores (mean=50, SD=10; range \~20-80). A T-score of 50 represents the population mean; scores 10 points above or below represent one standard deviation. Higher scores indicate better mental health (better outcome), and lower scores indicate worse mental health. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristine Goertz, DC, PhD
Duke University
PRINCIPAL_INVESTIGATORCynthia Long, PhD
Palmer Center for Chiropractic Research (PCCR)
Participant flow
Recruitment details
Veterans with chronic low back pain were recruited from four VA chiropractic clinics (Iowa City, IA; West Haven, CT; Minneapolis, MN; Los Angeles, CA) between February 2021 and May 2024. Recruitment used three strategies: existing VA chiropractic referrals, EHR prescreening, and self-referral. Invitations were sent by postal mail, with email added after IRB approval. Screening and enrollment were coordinated by site study coordinators.
Pre-assignment details
Potential participants were screened using a standardized five-step process: identification and notification, phone screening, informed consent and baseline visit (virtual or in person), eligibility questionnaires, and in-person chiropractic consultation to confirm clinical eligibility. Veterans who were uninterested, ineligible, or unable to complete screening before consultation were excluded. A total of 3,667 veterans were screened; 766 met criteria and were enrolled and randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 51 Years |
| Average Number of Days Per Week With Low Back Pain at Baseline | 7 days per week (0-7) |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 651 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 23 Participants |
| Pain Intensity (baseline) | 6.2 score on a scale (0-10) STANDARD_DEVIATION 1.7 |
| PEG Pain Severity (baseline) | 6.2 score on a scale (0-10) STANDARD_DEVIATION 1.8 |
| Physical and Social Health at Baseline (PROMIS) Fatigue | 61.5 T-score (PROMIS standardized score) STANDARD_DEVIATION 7.8 |
| Physical and Social Health at Baseline (PROMIS) Global Mental Health | 59.2 T-score (PROMIS standardized score) STANDARD_DEVIATION 8.7 |
| Physical and Social Health at Baseline (PROMIS) Global Physical Health | 62.8 T-score (PROMIS standardized score) STANDARD_DEVIATION 5.8 |
| Physical and Social Health at Baseline (PROMIS) Pain Interference | 63.7 T-score (PROMIS standardized score) STANDARD_DEVIATION 4.9 |
| Physical and Social Health at Baseline (PROMIS) Sleep Disturbance | 60.2 T-score (PROMIS standardized score) STANDARD_DEVIATION 8.2 |
| Physical and Social Health at Baseline (PROMIS) Social Roles Satisfaction | 58.9 T-score (PROMIS standardized score) STANDARD_DEVIATION 6.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 58 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 33 Participants |
| Race (NIH/OMB) White | 532 Participants |
| Roland Morris Disability Questionnaire (baseline score) | 12.2 score on a scale (0-24) STANDARD_DEVIATION 5.3 |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 301 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 382 | 1 / 384 | 0 / 172 | 0 / 172 | 0 / 169 | 2 / 164 |
| other Total, other adverse events | 0 / 382 | 0 / 384 | 0 / 172 | 0 / 172 | 2 / 169 | 0 / 164 |
| serious Total, serious adverse events | 11 / 382 | 13 / 384 | 19 / 172 | 15 / 172 | 19 / 169 | 13 / 164 |
Outcome results
None listed