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Musculoskeletal InjuryNCT02472067

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

A study testing Psychologically - Based Physical Therapy in people with Musculoskeletal Injury, run by NYU Langone Health.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Musculoskeletal Injury
What is being tested?
Psychologically - Based Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
No sites listed yet
Study dates
30 Jun 2015to 30 Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

About this study

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

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
Read the 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.

Being tested
Psychologically - Based Physical Therapy
Keywords
Musculoskeletal Injury, physical therapy, psychological intervention, risk factors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychologically - Based Physical TherapyBehavioural

    Psychologically - Based Physical Therapy targeting risk factors for disability.

Study groups in NCT02472067
Study groupRoleWhat they receive
Physical TherapyNo interventionUsual care of physical therapy and rehabilitation for a musculoskeletal injury. Patients complete self-rated standardized surveys before and following treatment.
Psychologically-Based Physical TherapyExperimentalPsychologically-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.
Receives: Behavioral: Psychologically - Based Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychological Distress (STarT Back Generic Screening Tool)

    Measured using the STarT Back Generic Screening Tool.

    Measured: Change from baseline to one month following treatment.

  2. Expectations of Recovery (single item question )

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

    Measured: Change from baseline to one month following treatment.

  3. Self-Efficacy (COMI)

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

    Measured: Change from baseline to one month following treatment.

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

    Measured using questions adapted from the STarT Back Screening Tool.

    Measured: Change from baseline to one month following treatment.

  5. Quality of Life (SF-12)

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

    Measured: Measured one month following treatment.

  6. Perceived Disability (COMI)

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

    Measured: Change from baseline to one month following treatment.

  7. Pain Interference (DVPRS)

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

    Measured: Change from baseline to one month following treatment.

  8. Satisfaction with Process of Care (MRPS)

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

    Measured: Measured one month after treatment.

  9. Outcome Satisfaction (COMI)

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

    Measured: Measured one month after treatment.

Secondary outcomes (2)

  1. Health Care Utilization (AHLTA)

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

    Measured: Measured at six month follow-up

  2. Limited Duty (MEDBOLTT Database)

    Measured using the MEDBOLTT Database.

    Measured: Measured at six month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2015 (estimated)
  2. Study start30 Jun 2015
  3. Primary completion17 Jun 2016
  4. Study completion30 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02472067
Sponsor's protocol ID
13-01166
Status last verified
Oct 2017
First submitted
11 Jun 2015
Last updated
13 Oct 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 23025138

  • 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

  • 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.

    PubMed 22227177

Questions about this trial

What is this clinical trial studying?

A study testing Psychologically - Based Physical Therapy in people with Musculoskeletal Injury, run by NYU Langone Health.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychological Distress (STarT Back Generic Screening Tool) (time frame: Change from baseline to one month following treatment.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02472067, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.

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