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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Washington
-
Tacoma, Washington, 미국, 98431
- Madigan Army Medical Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Complementary and Integrative Therapies
Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction
|
Intervention time period is 3 - 6 weeks.
|
|
활성 비교기: Standard Rehabilitative Care
Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy
|
Intervention time period is 3 - 6 weeks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from Baseline Pain Intensity
기간: 3 months
|
Pain Intensity 10-pt Numeric Rating Scale
|
3 months
|
|
Change from Baseline Pain Impact
기간: 3 months
|
Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)
|
3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Depression
기간: 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
|
|
Anxiety
기간: 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
기간: 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
|
|
Sleep Disturbance
기간: 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
|
|
Fatigue
기간: 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
|
|
PTSD
기간: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
Primary Care PTSD Screen
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
|
Patient Activation Measure
기간: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
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.
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
|
Drug Use
기간: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
Drug Use Questionnaire
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
|
Pain Catastrophizing
기간: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
Pain Catastrophizing Scale
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
|
Kinesiophobia
기간: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
Tampa Scale for Kinesiophobia
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
|
Pain Self-Efficacy
기간: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
Pain Self Efficacy Questionnaire
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
|
Chronic Pain Acceptance
기간: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
Chronic Pain Acceptance Questionnaire
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
|
Functional Capacity
기간: 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
|
|
Opioid Utilization
기간: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
Opioid Utilization Screener
|
baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
|
|
Cortisol
기간: baseline, 6 weeks
|
Salivary Cortisol
|
baseline, 6 weeks
|
|
Oxidative Stress
기간: baseline, 6 weeks
|
Urine Sample
|
baseline, 6 weeks
|
|
Genomic DNA
기간: baseline
|
Buccal Sample
|
baseline
|
|
Army Physical Fitness Test (APFT)
기간: baseline, 6 weeks, 3 months, 6 months
|
Passing scores of 60 on all 3 components (push-ups, sit-ups, 2-mile run) of the APFT will be operationalized as "force-readiness".
|
baseline, 6 weeks, 3 months, 6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ardith Z Doorenbos, RN, PhD, University of Washington
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
만성 통증에 대한 임상 시험
-
Hospital Clinic of BarcelonaAstraZeneca완전한CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자스페인
-
Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
-
Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
-
Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
-
Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)