Skip to main content
OpenTrials
Completed

NCT Number: NCT02472067

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

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

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Psychologically - Based Physical Therapy

Behavioral

Psychologically - Based Physical Therapy targeting risk factors for disability.

Primary outcomes

  1. Psychological Distress (STarT Back Generic Screening Tool)

    Time frame: Change from baseline to one month following treatment.

    Measured using the STarT Back Generic Screening Tool.

  2. Expectations of Recovery (single item question )

    Time frame: Change from baseline to one month following treatment.

    Measured using a single item question constructed by the research team.

  3. Self-Efficacy (COMI)

    Time frame: Change from baseline to one month following treatment.

    Measured using adapted questions from the Core Outcome Measurements Index (COMI).

  4. Fear Of Work Activity (STarT Back Screening Tool)

    Time frame: Change from baseline to one month following treatment.

    Measured using questions adapted from the STarT Back Screening Tool.

  5. Quality of Life (SF-12)

    Time frame: Measured one month following treatment.

    Measured using questions adapted from Short Form Health Survey(SF-12)

  6. Perceived Disability (COMI)

    Time frame: Change from baseline to one month following treatment.

    Measured using adapted questions from the Core Outcome Measurements Index (COMI).

  7. Pain Interference (DVPRS)

    Time frame: Change from baseline to one month following treatment.

    Measured using the Defense and Veterans Pain rating Scale (DVPRS).

  8. Satisfaction with Process of Care (MRPS)

    Time frame: Measured one month after treatment.

    Measured using the MedRisk Instrument for Measuring Patient Satisfaction (MRPS)

  9. Outcome Satisfaction (COMI)

    Time frame: Measured one month after treatment.

    Measured using adapted questions from the Core Outcome Measurements Index (COMI).

Secondary outcomes

  1. Health Care Utilization (AHLTA)

    Time frame: Measured at six month follow-up

    Measured using the Armed Forces Health Longitudinal Technology Application (AHLTA).

  2. Limited Duty (MEDBOLTT Database)

    Time frame: Measured at six month follow-up

    Measured using the MEDBOLTT Database.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Official study title

A Pilot Study to Test the Efficacy of Psychologically-Based Physical Therapy Training for Treating Deployed U.S. Sailors and Marines With Musculoskeletal Injuries

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 15, 2015
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.