VERDICT (Veterans Response to Dosage in Chiropractic Therapy): A Pragmatic Randomized Trial Addressing Dose Effects for Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 766
- 试验地点
- 7
- 主要终点
- Change from Baseline Low Back Pain Disability at several time points - Roland Morris Disability Questionnaire (RMDQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 email address
- •Participating in another study investigating treatment(s) for pain
- •Current or planned hospice care
- •Current or planned pregnancy
研究组 & 干预措施
Phase 1: Low Dose (1-5 visits)
Veterans with cLBP who will be randomly allocated to undergo a course of a low dose (1-5 visits) of multimodal, evidence-based chiropractic care for 10 weeks (Phase 1).
干预措施: Chiropractic Care (Other)
Phase 1: Higher Dose (8-12 visits)
Veterans with cLBP who will be randomly allocated to undergo a course of a higher dose (8-12 visits) of multimodal, evidence-based chiropractic care for 10 weeks (Phase 1).
干预措施: Chiropractic Care (Other)
Phase 2: CCPM
After Phase 1, Veterans with cLBP who will be randomly allocated again to receive chiropractic chronic pain management (CCPM) consisting of scheduled monthly chiropractic care for 10 months.
干预措施: Chiropractic Care (Other)
Phase 2: No CCPM
Participants who completed Phase 1 and consented to continue participation were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care. Participants could continue to access other VA healthcare services as clinically indicated.
结局指标
主要结局
Change from Baseline Low Back Pain Disability at several time points - Roland Morris Disability Questionnaire (RMDQ)
时间窗: At Baseline and Weeks 5, 10, 26, 40, and 52
A one-page, 24-item questionnaire related to low back pain disability. The RMDQ can discriminate between different forms of treatment for back pain, and is sensitive to clinical change.
Number of Participants With Clinically Meaningful Improvement in Back-Related Disability From Baseline to Week 10
时间窗: 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)
时间窗: 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.
次要结局
- Healthcare Services Utilization(52 weeks)
- Low Back Pain Intensity Change From Baseline to Week 10(Baseline to Week 10)
- PEG Pain Severity Change From Baseline to Week 10(Baseline to Week 10)
- Physical and Social Health Change From Baseline to Week 10 (PROMIS)(Baseline to Week 10)
- Global Mental Health: Physical and Social Health Change From Baseline to Week 10 (PROMIS)(Baseline to Week 10)
- Average Number of Days Per Week With Low Back Pain at Week 10(Week 10)
- Low Back Pain Intensity Change From Baseline to Week 52(Baseline to Week 52)
- PEG Pain Severity Change From Baseline to Week 52(Baseline to Week 52)
- Physical and Social Health Change From Baseline to Week 52 (PROMIS)(Baseline to Week 52)
- Average Number of Days Per Week With Low Back Pain at Week 52(Week 52)