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

NCT02472067 | Completed DMC

• 1 other identifier: 13-01166
• Study Type: interventional
• Target: 175
• Locations: 0 countries
• Sites: N/A

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:

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

Conditions

Musculoskeletal Injury

Keywords

Musculoskeletal Injury; physical therapy; psychological intervention; risk factors

Outcome Measures

Primary Outcomes (9)

• Psychological Distress (STarT Back Generic Screening Tool)

  Measured using the STarT Back Generic Screening Tool.

  Change from baseline to one month following treatment.

• 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.

• Self-Efficacy (COMI)

  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)

  Measured using questions adapted from the STarT Back Screening Tool.

  Change from baseline to one month following treatment.

• Quality of Life (SF-12)

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

  Measured one month following treatment.

• Perceived Disability (COMI)

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

  Change from baseline to one month following treatment.

• Pain Interference (DVPRS)

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

  Change from baseline to one month following treatment.

• Satisfaction with Process of Care (MRPS)

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

  Measured one month after treatment.

• Outcome Satisfaction (COMI)

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

  Measured one month after treatment.

Secondary Outcomes (2)

• Health Care Utilization (AHLTA)

  Measured at six month follow-up

• Limited Duty (MEDBOLTT Database)

  Measured at six month follow-up

Study Arms (2)

Physical Therapy

NO INTERVENTION

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

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

Interventions

Psychologically - Based Physical Therapy BEHAVIORAL

Psychologically - Based Physical Therapy targeting risk factors for disability.

Psychologically-Based Physical Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• NYU Langone Health: lead
• Congressionally Directed Medical Research Programs: collaborator

Related 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. doi: 10.7205/milmed-d-12-00118.

  PMID: 23025138 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 22227177 BACKGROUND

Study Officials

• Sherri Weiser-Horwitz, PhD

  NYU Medical Centre and School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 15, 2015
• Study Start: June 30, 2015
• Primary Completion: June 17, 2016
• Study Completion: June 30, 2016
• Last Updated: October 13, 2017

Record last verified: 2017-10