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

Musculoskeletal Injury Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472067
• Other study ID #: 13-01166
• Status: Completed
• Phase: N/A
• First received: June 11, 2015
• Last updated: October 11, 2017
• Start date: June 30, 2015
• Est. completion date: June 30, 2016

Study information

• Verified date: October 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: June 30, 2016
• Est. primary completion date: June 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Musculoskeletal Injury
• Wounds and Injuries

Intervention

Behavioral:
• Psychologically - Based Physical Therapy
Psychologically - Based Physical Therapy targeting risk factors for disability.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Congressionally Directed Medical Research Programs

References & Publications (3)

Campello M, Ziemke G, Hiebert R, Weiser S, Brinkmeyer M, Fox B, Dail J, Kerr S, Hinnant I, Nordin M. Implementation of a multidisciplinary program for active duty personnel seeking care for low back pain in a U.S. Navy Medical Center: a feasibility study. Mil Med. 2012 Sep;177(9):1075-80. — View Citation

Hiebert R, Campello MA, Weiser S, Ziemke GW, Fox BA, Nordin M. Predictors of short-term work-related disability among active duty US Navy personnel: a cohort study in patients with acute and subacute low back pain. Spine J. 2012 Sep;12(9):806-16. doi: 10.1016/j.spinee.2011.11.012. Epub 2012 Jan 9. — View Citation

Ziemke GW, Campello M, Rennix CP, Keer S, Zook J, Nordin M, et al. Retrospective Administrative Limited Duty Outcome Review Lovelace Respiratory Research Institute; 2012. Report No.: Contract Number 2011.029

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological Distress (STarT Back Generic Screening Tool)	Measured using the STarT Back Generic Screening Tool.	Change from baseline to one month following treatment.
Primary	Expectations of Recovery (single item question )	Measured using a single item question constructed by the research team.	Change from baseline to one month following treatment.
Primary	Self-Efficacy (COMI)	Measured using adapted questions from the Core Outcome Measurements Index (COMI).	Change from baseline to one month following treatment.
Primary	Fear Of Work Activity (STarT Back Screening Tool)	Measured using questions adapted from the STarT Back Screening Tool.	Change from baseline to one month following treatment.
Primary	Quality of Life (SF-12)	Measured using questions adapted from Short Form Health Survey(SF-12)	Measured one month following treatment.
Primary	Perceived Disability (COMI)	Measured using adapted questions from the Core Outcome Measurements Index (COMI).	Change from baseline to one month following treatment.
Primary	Pain Interference (DVPRS)	Measured using the Defense and Veterans Pain rating Scale (DVPRS).	Change from baseline to one month following treatment.
Primary	Satisfaction with Process of Care (MRPS)	Measured using the MedRisk Instrument for Measuring Patient Satisfaction (MRPS)	Measured one month after treatment.
Primary	Outcome Satisfaction (COMI)	Measured using adapted questions from the Core Outcome Measurements Index (COMI).	Measured one month after treatment.
Secondary	Health Care Utilization (AHLTA)	Measured using the Armed Forces Health Longitudinal Technology Application (AHLTA).	Measured at six month follow-up
Secondary	Limited Duty (MEDBOLTT Database)	Measured using the MEDBOLTT Database.	Measured at six month follow-up