A Pilot Study to Test the Efficacy of Psychologically-Based Physical Therapy Training for Treating Deployed U.S. Sailors and Marines With Musculoskeletal Injuries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 主要终点
- Quality of Life (SF-12)
研究概览
简要总结
The main objective of this pilot project is to demonstrate the effectiveness of a psychologically-based physical therapy (PBPT) intervention for the prevention of disability in Active Duty Service Members who sustained a musculoskeletal injury (MSI) during deployment in support of combat operations on a carrier. This intervention is intended to optimize recovery and restore function in injured Active Duty Service Members.
The three aims necessary to accomplish the main objective are:
- Demonstrate the feasibility of implementing PBPT on board a carrier;
- Document and compare risk factors related to disability from MSI aboard two carriers;
- Demonstrate the effectiveness of the PBPT intervention in a comparative effectiveness trial
详细描述
Musculoskeletal injuries pose a significant problem for Active Duty Service Members and are the main reason for separation and long-term disability. Little information exists on the determinants of disability and seeking care patterns in Sailors and Marines who experience MSI during deployment in support of combat operations, despite the fact that these branches of the armed services have the highest level of attrition from these disorders of all branches PBPT implemented in this setting has the potential to have a dramatic impact on the study outcomes. It is expected that an intervention of psychologically-based physical therapy targeting the common psychological risk factors (yellow flags) that include fear of activity including work, psychological distress, and perceived disability will be effective in reducing these risk factors and optimizing recovery and restoring function in the intervention group. Active Duty Service Members who seek care for a MSI on a carrier will benefit from early care by a trained physical therapist, which will reduce the likelihood of the formation or maintenance of maladaptive beliefs about injury previously found to be associated with disability.
The proposed study design is a quasi-experimental, pre-post- test with a non-concurrent control group to test the effectiveness of psychologically-based physical therapy aboard a US Navy Aircraft Carrier.
This approach will consist of one deployed carrier serving as the intervention and a second carrier serving as a control. The two carriers (intervention and equivalent control) will be chosen based on deployment schedules. Both carriers will have similar deployment characteristics to include; length of deployment, crew size and deployed health care team. For the purposes of this project, measurements will be done during deployment (pre physical therapy intervention and one month after enrollment) and after deployment. Thus, two different endpoints will be used, a post treatment endpoint (one month after enrollment), and a second which takes place after the carrier returns from deployment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects presenting to medical for a primary complaint of a new MSI. A new MSI is considered in this study when the subject has not sought treatment for a period of 30 days or more prior to presenting to medical.
排除标准
- •Subjects not eligible include those who require medical evacuation, or have a trauma/ comorbidities that may prevent them from receiving physical therapy treatment (i.e. amputations, fractures, contusions and other 'Red Flags' that required specialized medical care).
研究组 & 干预措施
Physical Therapy
Usual care of physical therapy and rehabilitation for a musculoskeletal injury. Patients complete self-rated standardized surveys before and following treatment.
Psychologically-Based Physical Therapy
Psychologically-Based Physical Therapy includes the early identification and management of psychological obstacles to recovery in order to modify maladaptive responses previously found to be associated with chronicity and disability. This is accomplished through patient education, an emphasis on functional goals and encouraging self-care techniques. Patients complete self-rated standardized surveys before and following treatment.
干预措施: Psychologically - Based Physical Therapy (Behavioral)
结局指标
主要结局
Quality of Life (SF-12)
时间窗: Measured one month following treatment.
Measured using questions adapted from Short Form Health Survey(SF-12)
Pain Interference (DVPRS)
时间窗: Change from baseline to one month following treatment.
Measured using the Defense and Veterans Pain rating Scale (DVPRS).
Outcome Satisfaction (COMI)
时间窗: Measured one month after treatment.
Measured using adapted questions from the Core Outcome Measurements Index (COMI).
Psychological Distress (STarT Back Generic Screening Tool)
时间窗: Change from baseline to one month following treatment.
Measured using the STarT Back Generic Screening Tool.
Expectations of Recovery (single item question )
时间窗: Change from baseline to one month following treatment.
Measured using a single item question constructed by the research team.
Perceived Disability (COMI)
时间窗: Change from baseline to one month following treatment.
Measured using adapted questions from the Core Outcome Measurements Index (COMI).
Self-Efficacy (COMI)
时间窗: Change from baseline to one month following treatment.
Measured using adapted questions from the Core Outcome Measurements Index (COMI).
Fear Of Work Activity (STarT Back Screening Tool)
时间窗: Change from baseline to one month following treatment.
Measured using questions adapted from the STarT Back Screening Tool.
Satisfaction with Process of Care (MRPS)
时间窗: Measured one month after treatment.
Measured using the MedRisk Instrument for Measuring Patient Satisfaction (MRPS)
次要结局
- Health Care Utilization (AHLTA)(Measured at six month follow-up)
- Limited Duty (MEDBOLTT Database)(Measured at six month follow-up)