Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury
Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury
調査の概要
状態
条件
詳細な説明
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.
Projected Timeline. This research will determine the optimal combination, sequence, and duration of therapies. It is expected that some active duty Service members could see improvements in function and quality of life within three weeks, but others may require up to six weeks to experience meaningful improvement.
Benefit to Military Personnel. This research will benefit Service members experiencing pain due to neuromusculoskeletal injury. It will identify ways to direct them to the therapies most likely to yield meaningful improvements in function and quality of life, and thus facilitate their return to duty. The recommendations from this study will be shared with pain management centers throughout the DoD, VHA; and, we hope, eventually to TRICARE members.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Washington
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Tacoma、Washington、アメリカ、98431
- Madigan Army Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- Major surgeries within past 6 months or planned within next 6 months
- Unstable psychological disorders
- Active substance use disorder
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Complementary and Integrative Therapies
Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction
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Intervention time period is 3 - 6 weeks.
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アクティブコンパレータ：Standard Rehabilitative Care
Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy
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Intervention time period is 3 - 6 weeks.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline Pain Intensity
時間枠：3 months
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Pain Intensity 10-pt Numeric Rating Scale
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3 months
|
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Change from Baseline Pain Impact
時間枠：3 months
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Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)
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3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Depression
時間枠：baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Patient Reported Outcome Measurement Information System
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
|
Anxiety
時間枠：baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
Patient Reported Outcome Measurement Information System
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
|
Emotional Distress - Anger
時間枠：baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Patient Reported Outcome Measurement Information System
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
|
Sleep Disturbance
時間枠：baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Patient Reported Outcome Measurement Information System
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
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Fatigue
時間枠：baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Patient Reported Outcome Measurement Information System
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baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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PTSD
時間枠：baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Primary Care PTSD Screen
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baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Patient Activation Measure
時間枠：baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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A 22-item survey that addresses four stages of patient activation: (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress.
Patients are asked to agree or not to agree with each of the 22 items.
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baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Drug Use
時間枠：baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Drug Use Questionnaire
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baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
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Pain Catastrophizing
時間枠：baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Pain Catastrophizing Scale
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baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Kinesiophobia
時間枠：baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Tampa Scale for Kinesiophobia
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baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
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Pain Self-Efficacy
時間枠：baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Pain Self Efficacy Questionnaire
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Chronic Pain Acceptance
時間枠：baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Chronic Pain Acceptance Questionnaire
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baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
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Functional Capacity
時間枠：baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
Roland-Morris Disability Questionnaire and Canadian Occupational Performance Measure
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
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Opioid Utilization
時間枠：baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
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Opioid Utilization Screener
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
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Cortisol
時間枠：baseline, 6 weeks
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Salivary Cortisol
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baseline, 6 weeks
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Oxidative Stress
時間枠：baseline, 6 weeks
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Urine Sample
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baseline, 6 weeks
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Genomic DNA
時間枠：baseline
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Buccal Sample
|
baseline
|
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Army Physical Fitness Test (APFT)
時間枠：baseline, 6 weeks, 3 months, 6 months
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Passing scores of 60 on all 3 components (push-ups, sit-ups, 2-mile run) of the APFT will be operationalized as "force-readiness".
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baseline, 6 weeks, 3 months, 6 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Ardith Z Doorenbos, RN, PhD、University of Washington
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
慢性の痛みの臨床試験
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