Psychologically-Based Physical Therapy Treatment for Deployed U.S. Sailors and Marines With Musculoskeletal Injuries

NYU Langone Health

Status: Completed

Conditions: Musculoskeletal Injury

Treatments: Behavioral: Psychologically - Based Physical Therapy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02472067

13-01166

Details and patient eligibility

About

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:

1. Demonstrate the feasibility of implementing PBPT on board a carrier;
2. Document and compare risk factors related to disability from MSI aboard two carriers;
3. Demonstrate the effectiveness of the PBPT intervention in a comparative effectiveness trial

Full description

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.

Enrollment: 175 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

175 participants in 2 patient groups

Physical Therapy

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Behavioral: Psychologically - Based Physical Therapy