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

October 11, 2017 updated by: NYU Langone Health

A Pilot Study to Test the Efficacy of Psychologically-Based Physical Therapy Training for Treating 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Physical Therapy
Usual care of physical therapy and rehabilitation for a musculoskeletal injury. Patients complete self-rated standardized surveys before and following treatment.
Experimental: 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.
Behavioral: Psychologically - Based Physical Therapy
Psychologically - Based Physical Therapy targeting risk factors for disability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to one month following treatment.
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.
Change from baseline to one month following treatment.
Self-Efficacy (COMI)
Time Frame: Change from baseline to one month following treatment.
Measured using adapted questions from the Core Outcome Measurements Index (COMI).
Change from baseline to one month following treatment.
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.
Change from baseline to one month following treatment.
Quality of Life (SF-12)
Time Frame: Measured one month following treatment.
Measured using questions adapted from Short Form Health Survey(SF-12)
Measured one month following treatment.
Perceived Disability (COMI)
Time Frame: Change from baseline to one month following treatment.
Measured using adapted questions from the Core Outcome Measurements Index (COMI).
Change from baseline to one month following treatment.
Pain Interference (DVPRS)
Time Frame: Change from baseline to one month following treatment.
Measured using the Defense and Veterans Pain rating Scale (DVPRS).
Change from baseline to one month following treatment.
Satisfaction with Process of Care (MRPS)
Time Frame: Measured one month after treatment.
Measured using the MedRisk Instrument for Measuring Patient Satisfaction (MRPS)
Measured one month after treatment.
Outcome Satisfaction (COMI)
Time Frame: Measured one month after treatment.
Measured using adapted questions from the Core Outcome Measurements Index (COMI).
Measured one month after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Care Utilization (AHLTA)
Time Frame: Measured at six month follow-up
Measured using the Armed Forces Health Longitudinal Technology Application (AHLTA).
Measured at six month follow-up
Limited Duty (MEDBOLTT Database)
Time Frame: Measured at six month follow-up
Measured using the MEDBOLTT Database.
Measured at six month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

Congressionally Directed Medical Research Programs

Investigators

  • Principal Investigator: Sherri Weiser-Horwitz, PhD, NYU Medical Centre and School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2015

Primary Completion (Actual)

June 17, 2016

Study Completion (Actual)

June 30, 2016

Study Registration Dates

First Submitted

June 11, 2015

First Submitted That Met QC Criteria

June 12, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-01166

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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