Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Change from Baseline Pain Intensity
研究概览
简要总结
This study will (1) compare the effectiveness of standard rehabilitative pain care with complementary and integrative pain therapies; (2) identify subgroups of patients who do and do not respond to the intervention(s); (3) determine the most effective sequencing of the interventions; and (4) determine factors associated with treatment response that can be implemented to support clinical decision-making.
详细描述
Objectives and Rationale. Pain due to neuromusculoskeletal injuries is a leading cause of disability among active duty military Service members. The injury rate is significant with 628 neuromusculoskeletal injuries per 1000 person-years among active duty military Service members. Neuromusculoskeletal injuries include amputations following battlefield trauma, repetitive motion injuries related to equipment use or weight-bearing postures, and even injuries or strains incurred during off-duty pursuits. Regardless of cause, the effects on both individual Service members and military readiness are significant: Only 13% of Service members being treated primarily for pain ever return to the field.
The Department of Defense (DoD) has recently expanded its capacity to provide both functional restoration (FR) and complementary and integrative medicine (CIM) therapies for neuromusculoskeletal injury, pain, and disability. The proposed research aims to determine the most effective treatment combination, sequence, and duration of standard rehabilitative care (SRC), such as physical and occupational therapy in combination with cognitive behavioral therapy and CIM therapies, such as acupuncture and chiropractic, for Service members preparing to enroll in an intensive FR program that is currently the DoD-recommended treatment. In addition, this study aims to identify ways to predict in advance which patients will respond best to which therapeutic regimens.
Potential Impact. This research has the potential to determine which patients are most likely to benefit from the non-medication pain therapies currently available in all Army Interdisciplinary Pain Management Centers (IPMC) and how these therapies can most effectively be combined to achieve the greatest improvements in pain impact, quality of life and ability to return to duty following injury.
Patients Who Will Benefit. This study will involve active duty Service members referred to an Army IPMC. The results will be shared with other Military Health System (MHS) and Veterans Health Administration (VHA) pain management centers so that active duty Service members and veterans across United States may benefit from a treatment approach that is tailored to their individual characteristics. It is anticipated that the knowledge gained through this research will be applicable to family members of Service members and veterans and will ultimately lead to expansion of TRICARE benefits to include CIM therapies.
Potential Clinical Applications, Benefits, and Risks. This research will assist providers in determining when to refer their patients with neuromusculoskeletal pain for SRC and/or CIM therapies prior to FR. It will assist IPMCs in developing treatment plans tailored to the needs of each patient. Service members and veterans will benefit by being referred for these approaches when appropriate during the course of disabling chronic pain conditions. Ultimately, it is hoped that decision tools can be imbedded in the electronic medical record to guide health care providers to consider referral for these therapies in patients who may benefit. This study will advance our ability to effectively tailor therapies for rehabilitation from neuromusculoskeletal pain for different patients to yield the greatest benefit in physical function and quality of life. The risks of these interventions are minimal; Service members may experience general muscle soreness for the first week or so of increased physical activity, but this typically resolves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active duty service members
- •Neuromusculoskeletal or neuropathic pain ≥ 3-months duration
- •Pain of sufficient severity to bring about dysfunction in daily social, vocational, and/or interpersonal activities
排除标准
- •Major surgeries within past 6 months or planned within next 6 months
- •Unstable psychological disorders
- •Active substance use disorder
研究组 & 干预措施
Complementary and Integrative Therapies
Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction
干预措施: Complementary and Integrative Therapies (Behavioral)
Standard Rehabilitative Care
Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy
干预措施: Standard Rehabilitative Care (Behavioral)
结局指标
主要结局
Change from Baseline Pain Intensity
时间窗: 3 months
Pain Intensity 10-pt Numeric Rating Scale
Change from Baseline Pain Impact
时间窗: 3 months
Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)
次要结局
- Genomic DNA(baseline)
- Opioid Utilization(baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months)
- Cortisol(baseline, 6 weeks)
- Anxiety(baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months)
- Emotional Distress - Anger(baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months)
- Sleep Disturbance(baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months)
- Fatigue(baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months)
- PTSD(baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months)
- Patient Activation Measure(baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months)
- Drug Use(baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months)
- Pain Catastrophizing(baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months)
- Functional Capacity(baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months)
- Depression(baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months)
- Kinesiophobia(baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months)
- Pain Self-Efficacy(baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months)
- Chronic Pain Acceptance(baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months)
- Oxidative Stress(baseline, 6 weeks)
- Army Physical Fitness Test (APFT)(baseline, 6 weeks, 3 months, 6 months)
研究者
Ardith Doorenbos
Professor
University of Washington