Prospective Assessment of Integrative Therapies for Neuromusculoskeletal Pain (PAIN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- David Moss
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Dallas Pain Questionnaire
研究概览
简要总结
With vast numbers of active-duty members restricted from their specific duties or deemed unfit for deployment because of low back pain, both the mission of the Department of Defense and overall military workflow can be significantly impacted. More than restriction from duty or being barred from deployment, studies have shown musculoskeletal conditions were among the top reasons for medical disability retirement in the Army and Marine Corps (Niebuhr; Sikorski). Given the significant time, money, and resources invested in training these members, each day of inactivity or disability detrimentally affects the execution of the military's mission. Therefore, precise diagnosis and effective treatment modalities are paramount to foster healing and reduce recovery time.
From an operational standpoint, the United States Department of Defense (DoD) is specifically interested in using tailored integrative medicine modalities to manage chronic conditions encountered in the military health system. Not just chronic pain, but polytrauma and the triad of conditions it encompasses; traumatic brain injury and post-traumatic stress disorder combined with chronic pain (Madsen, Kim, Bedard). The DoD's goal is also to decrease opioid prescribing and the addiction and altered state associated with opioids.
AT the Nellis Integrative Medicine Clinic, physicians, a chiropractor, and nurses are engaged in the treatment of patients. All personnel are trained in the various modalities available in the clinics.
A variety of modalities are utilized in the clinic. This prospective study will evaluate the effectiveness of the many modalities used in the Integrative Medicine Clinic (such as acupuncture, myofascial therapies, microcurrent therapies, LASER therapy, extracorporeal shockwave therapy, and pulsed electromagnetic therapies).
Most patients receive treatments using multiple modalities. DoD goals align with our experiences in the Integrative Medicine Clinic at Mike O'Callaghan Military Medical Center. Many servicemembers and dependents in our clinic are trying to avoid surgery, or their pain medications - opioid or not - are no longer working. Additionally, many patients are trying to avoid Do Not Fly status caused by pharmacologic approaches. Patient experiences at our IMC also correlate with a study where 80% of people surveyed felt integrative medicine should be routinely offered at all MTFs (Ross). While our patients generally are not on opioids, we have anecdotally noted a reduction or cessation of opioids in several patients. The impacts of such a reduction in opioid usage for military readiness is clear (Madsen).
详细描述
All of the below items are research-related unless marked as 'standard of care'. Visits will vary depending on provider-decided treatments and will generally range from 30 minutes to 2 hours in length.
Self-reported pain intensity assessment.
Screening visit (1 hour):
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Obtain and document signed Informed Consent document and HIPAA Authorization
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Verify subject eligibility based on inclusion/exclusion criteria. Medical record will verify inclusion.
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-Record all medications including over the counter the subject is taking. Record morphine milligram equivalents (MME) for patients taking opioid medications. Collect basic demographic information to include phone number, email address, DoD ID, age, race, ethnicity, assigned sex at birth, weight (pounds), height (inches), and BMI, estimated annual income.
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Collect additional information to include:
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Beneficiary Status (Active-Duty, Retired Active-Duty, dependent, Reservist)
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rank (if applicable),
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employment status and description (full time, part time, unemployed, retired, homemaker) number of deployments (if applicable), Marital status (Married, Domestic Partners, Divorced, Widow/er, separated, single/never married)
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education (military training; high school/GED; some college; 2 year college; 4 year college; some graduate work; completed master's or professional degree; completed Ph.D., law degree, MD, similar advanced professional degree)
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Patient History, was there a precipitating injury, location of pain (neck, thoracic, or lumbar), history of surgery and type of surgery, any history of pain management interventions (injections, ablations, etc) especially related to the subject's chronic axial spine pain
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Other therapies for their condition currently receiving or in the last 3 months (ie chiropractic, physical therapy, pain management etc) Randomization: Subjects will not be randomized as this is a single armed cohort study. Subjects will be assigned a unique study code in sequential order beginning with 001.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
- •Inclusion Criteria:
- •Active Duty and DoD Beneficiaries (i.e. former military, spouse, dependent child) aged 18 or older referred to the Nellis Integrative Medicine Clinic chronic back or neck pain
- •Pain Chronicity Threshold (pain score ≥4/10 documented in EMR or reported by patient at least 2 times in one year and at least 30 days apart).
排除标准
- •Enrolled in other pain management program (e.g. pain management, PT
- •Anticipated Change of station, deployment, retirement from military service, separation from active or reserve military service (includes national guard) or plan to discontinue enrollment at MOMMC in <6 months
- •Planned surgery during the study period
- •Pregnancy
- •<3 months post-partum
- •Hypermobility disorders such as Ehlers Danlos
- •Active cancer (cancer in remission is not an exclusion)
- •Implanted electrical devices that cannot be turned off (ie pacemaker); implanted stimulators or pumps that can be turned off are not exclusionary
- •Injury or surgery within the last 6 weeks
- •Inability to make medical decisions or understand treatment plan as decided upon by principle or associate investigators
- •Undergoing medical evaluation board
- •Currently in the process of establishing or appealing VA disability rating, or planning to do so within the study period
研究组 & 干预措施
Integrative Medicine (pre to post treatment)
Patients will act as their own control with preintervention scores. The main integrative medicine intervention therapies include but may not be limited to acupuncture, myofascial therapies, microcurrent therapies, LASER therapy, extracorporeal shockwave therapy, and pulsed electromagnetic therapies.
干预措施: Acupuncture (Other)
Integrative Medicine (pre to post treatment)
Patients will act as their own control with preintervention scores. The main integrative medicine intervention therapies include but may not be limited to acupuncture, myofascial therapies, microcurrent therapies, LASER therapy, extracorporeal shockwave therapy, and pulsed electromagnetic therapies.
干预措施: myofascial therapy (Other)
Integrative Medicine (pre to post treatment)
Patients will act as their own control with preintervention scores. The main integrative medicine intervention therapies include but may not be limited to acupuncture, myofascial therapies, microcurrent therapies, LASER therapy, extracorporeal shockwave therapy, and pulsed electromagnetic therapies.
干预措施: microcurrent therapy (Other)
Integrative Medicine (pre to post treatment)
Patients will act as their own control with preintervention scores. The main integrative medicine intervention therapies include but may not be limited to acupuncture, myofascial therapies, microcurrent therapies, LASER therapy, extracorporeal shockwave therapy, and pulsed electromagnetic therapies.
干预措施: LASER (Other)
Integrative Medicine (pre to post treatment)
Patients will act as their own control with preintervention scores. The main integrative medicine intervention therapies include but may not be limited to acupuncture, myofascial therapies, microcurrent therapies, LASER therapy, extracorporeal shockwave therapy, and pulsed electromagnetic therapies.
干预措施: extracorporeal shockwave therapy (Other)
Integrative Medicine (pre to post treatment)
Patients will act as their own control with preintervention scores. The main integrative medicine intervention therapies include but may not be limited to acupuncture, myofascial therapies, microcurrent therapies, LASER therapy, extracorporeal shockwave therapy, and pulsed electromagnetic therapies.
干预措施: Pulsed electromagnetic therapies (Other)
Integrative Medicine (pre to post treatment)
Patients will act as their own control with preintervention scores. The main integrative medicine intervention therapies include but may not be limited to acupuncture, myofascial therapies, microcurrent therapies, LASER therapy, extracorporeal shockwave therapy, and pulsed electromagnetic therapies.
干预措施: Miscellaneous integrative medicine (Other)
结局指标
主要结局
Dallas Pain Questionnaire
时间窗: baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
16 item quality of life questionnaire assessing multiple domains
PROMIS physical function form 6b
时间窗: baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
6 questions evaluating physical function
Patient Health Questionnaire 2-item (PHQ-2)
时间窗: baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
measures depressed mood and anhedonia over past 2 weeks
Defense and Veterans Pain Rating Scale
时间窗: baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
pain assessment tool using numerical rating scale enhanced by functional word descriptors, color coding, and pictorial facial expressions
PEG (pain average, enjoyment of life, and general activity)
时间窗: baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
assesses pain intensity and interference
Patient health questionnaire 9-item
时间窗: baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
measures more detailed depressed mood and anhedonia if patient scores 3 or higher on phq-2
Generalized Anxiety Disorder 2-item
时间窗: baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
screening tool for generalized anxiety disorder
Generalized Anxiety Disorder 7-item
时间窗: baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
extended screening tool for generalized anxiety disorder to use if subjects score 3 or higher on GAD-2
Pain Catastrophizing Scale
时间窗: baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
quantifies pain experience (rumination, magnification, and helplessness)
Pittsburgh Sleep Quality Index
时间窗: baseline (pre-treatment) through study period (visit 1, week 0) (visit 2, week 4) (visit 3, week 8) (visit 4, week 12) (visit 5, week 16) (visit 6, week 20) (visit 4, week 24) (visit 8, week 28)
Self-report questionnaire that assesses sleep quality over a one-month time interval. The global score ranges from 0 to 21. Higher scores indicate poorer sleep quality.
次要结局
未报告次要终点
研究者
David Moss
Principal Investigator/Doctor
Mike O'Callaghan Military Hospital