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

Primary Purpose

Musculoskeletal Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychologically - Based Physical Therapy
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Musculoskeletal Injury focused on measuring Musculoskeletal Injury, physical therapy, psychological intervention, risk factors

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Physical Therapy

    Psychologically-Based Physical Therapy

    Arm 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 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.

    Outcomes

    Primary Outcome Measures

    Psychological Distress (STarT Back Generic Screening Tool)
    Measured using the STarT Back Generic Screening Tool.
    Expectations of Recovery (single item question )
    Measured using a single item question constructed by the research team.
    Self-Efficacy (COMI)
    Measured using adapted questions from the Core Outcome Measurements Index (COMI).
    Fear Of Work Activity (STarT Back Screening Tool)
    Measured using questions adapted from the STarT Back Screening Tool.
    Quality of Life (SF-12)
    Measured using questions adapted from Short Form Health Survey(SF-12)
    Perceived Disability (COMI)
    Measured using adapted questions from the Core Outcome Measurements Index (COMI).
    Pain Interference (DVPRS)
    Measured using the Defense and Veterans Pain rating Scale (DVPRS).
    Satisfaction with Process of Care (MRPS)
    Measured using the MedRisk Instrument for Measuring Patient Satisfaction (MRPS)
    Outcome Satisfaction (COMI)
    Measured using adapted questions from the Core Outcome Measurements Index (COMI).

    Secondary Outcome Measures

    Health Care Utilization (AHLTA)
    Measured using the Armed Forces Health Longitudinal Technology Application (AHLTA).
    Limited Duty (MEDBOLTT Database)
    Measured using the MEDBOLTT Database.

    Full Information

    First Posted
    June 11, 2015
    Last Updated
    October 11, 2017
    Sponsor
    NYU Langone Health
    Collaborators
    Congressionally Directed Medical Research Programs
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02472067
    Brief Title
    Psychologically-Based Physical Therapy Treatment for Deployed U.S. Sailors and Marines With Musculoskeletal Injuries
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 30, 2015 (Actual)
    Primary Completion Date
    June 17, 2016 (Actual)
    Study Completion Date
    June 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NYU Langone Health
    Collaborators
    Congressionally Directed Medical Research Programs

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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: 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Musculoskeletal Injury
    Keywords
    Musculoskeletal Injury, physical therapy, psychological intervention, risk factors

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    175 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical Therapy
    Arm Type
    No Intervention
    Arm Description
    Usual care of physical therapy and rehabilitation for a musculoskeletal injury. Patients complete self-rated standardized surveys before and following treatment.
    Arm Title
    Psychologically-Based Physical Therapy
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychologically - Based Physical Therapy
    Intervention Description
    Psychologically - Based Physical Therapy targeting risk factors for disability.
    Primary Outcome Measure Information:
    Title
    Psychological Distress (STarT Back Generic Screening Tool)
    Description
    Measured using the STarT Back Generic Screening Tool.
    Time Frame
    Change from baseline to one month following treatment.
    Title
    Expectations of Recovery (single item question )
    Description
    Measured using a single item question constructed by the research team.
    Time Frame
    Change from baseline to one month following treatment.
    Title
    Self-Efficacy (COMI)
    Description
    Measured using adapted questions from the Core Outcome Measurements Index (COMI).
    Time Frame
    Change from baseline to one month following treatment.
    Title
    Fear Of Work Activity (STarT Back Screening Tool)
    Description
    Measured using questions adapted from the STarT Back Screening Tool.
    Time Frame
    Change from baseline to one month following treatment.
    Title
    Quality of Life (SF-12)
    Description
    Measured using questions adapted from Short Form Health Survey(SF-12)
    Time Frame
    Measured one month following treatment.
    Title
    Perceived Disability (COMI)
    Description
    Measured using adapted questions from the Core Outcome Measurements Index (COMI).
    Time Frame
    Change from baseline to one month following treatment.
    Title
    Pain Interference (DVPRS)
    Description
    Measured using the Defense and Veterans Pain rating Scale (DVPRS).
    Time Frame
    Change from baseline to one month following treatment.
    Title
    Satisfaction with Process of Care (MRPS)
    Description
    Measured using the MedRisk Instrument for Measuring Patient Satisfaction (MRPS)
    Time Frame
    Measured one month after treatment.
    Title
    Outcome Satisfaction (COMI)
    Description
    Measured using adapted questions from the Core Outcome Measurements Index (COMI).
    Time Frame
    Measured one month after treatment.
    Secondary Outcome Measure Information:
    Title
    Health Care Utilization (AHLTA)
    Description
    Measured using the Armed Forces Health Longitudinal Technology Application (AHLTA).
    Time Frame
    Measured at six month follow-up
    Title
    Limited Duty (MEDBOLTT Database)
    Description
    Measured using the MEDBOLTT Database.
    Time Frame
    Measured at six month follow-up

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sherri Weiser-Horwitz, PhD
    Organizational Affiliation
    NYU Medical Centre and School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23025138
    Citation
    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. doi: 10.7205/milmed-d-12-00118.
    Results Reference
    background
    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
    Results Reference
    background
    PubMed Identifier
    22227177
    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.
    Results Reference
    background

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

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