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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
766
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.
VA Greater Los Angeles Health Care System
Los Angeles, California, United States
VA Connecticut Healthcare System
West Haven, Connecticut, United States
Iowa City VA Health Care System
Iowa City, Iowa, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States
Number of Participants With Clinically Meaningful Improvement in Back-Related Disability From 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).
Time frame: Baseline to Week 10
Back-Related Disability Change From Baseline to Week 52 (RMDQ)
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.
Time frame: Baseline to Week 52
Low Back Pain Intensity Change From 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.
Time frame: Baseline to Week 10
PEG Pain Severity Change From 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.
Time frame: Baseline to Week 10
Physical and Social Health Change From Baseline to Week 10 (PROMIS)
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.
Time frame: Baseline to Week 10
Global Mental Health: Physical and Social Health Change From Baseline to Week 10 (PROMIS)
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.
Time frame: Baseline to Week 10
Average Number of Days Per Week With Low Back Pain at 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.
Time frame: Week 10
Low Back Pain Intensity Change From 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.
Time frame: Baseline to Week 52
PEG Pain Severity Change From 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.
Time frame: Baseline to Week 52
Physical and Social Health Change From Baseline to Week 52 (PROMIS)
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.
Time frame: Baseline to Week 52
Average Number of Days Per Week With Low Back Pain at 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.
Time frame: Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.