NCT02776930

Brief Summary

The purpose of this study is to develop algorithms that will help predict future injury and/or re-injury after being returned to duty from a musculoskeletal injury. After completion of an episode of care with a physical therapist, the subjects will undergo a battery of physical performance tests and fill out associated surveys. The subjects will then be followed for a year to identify the occurrence/re-occurence of any injuries. Based on the performance on the physical evaluation tests, algorithms will be derived using regression analysis to predict injury. Subjects will be recruited from the pool of patients that have recently completed physical rehabilitation in physical therapy clinics for their lower extremity or lumbar/thoracic spine injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

May 17, 2016

Last Update Submit

January 16, 2020

Conditions

Keywords

Injury PredictionReturn to WorkInjury Prevention

Outcome Measures

Primary Outcomes (1)

  • Injury Occurrence

    Monthly SMS survey capturing new musculoskeletal injury since the prior survey

    1 year

Secondary Outcomes (1)

  • Injury-Related Healthcare Utilization

    1 year

Study Arms (1)

Return to Duty after Rehab from Injury

Patients deemed healthy enough to return to full duty without any restrictions after completing a course of rehabilitation for a lumbar/thoracic spine or lower extremity injury.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Active duty service members that have completed a course of physical therapy for a spine or lower extremity injury, and then discharged to return to full duty.

You may qualify if:

  • Active duty service member eligible for Tricare benefits
  • Lower extremity or lumbar/thoracic spine injury is the patient's primary complaint.
  • Determined fit for duty (cleared to return to work) after completing a course of physical therapy for a lower extremity or lumbar/thoracic spine musculoskeletal injury

You may not qualify if:

  • Individuals planing on leaving the military within the next 10 months.
  • Trauma or polytrauma that results in amputation of any limbs or appendages.
  • Pregnancy, or recently pregnant within the last 6 months - subjects that become pregnant during the course of the study will be withdrawn based on the different injury risk factors that are associated with pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Womack Army Medical Center

Fort Bragg, North Carolina, 28307, United States

Location

William Beaumont Army Medical Center

Fort Bliss, Texas, 79920, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (18)

  • Lincoln AE, Smith GS, Amoroso PJ, Bell NS. The natural history and risk factors of musculoskeletal conditions resulting in disability among US Army personnel. Work. 2002;18(2):99-113.

    PMID: 12441574BACKGROUND
  • Ernat J, Knox J, Orchowski J, Owens B. Incidence and risk factors for acute low back pain in active duty infantry. Mil Med. 2012 Nov;177(11):1348-51. doi: 10.7205/milmed-d-12-00183.

    PMID: 23198512BACKGROUND
  • Knapik JJ, Graham B, Cobbs J, Thompson D, Steelman R, Jones BH. A prospective investigation of injury incidence and injury risk factors among Army recruits in military police training. BMC Musculoskelet Disord. 2013 Jan 17;14:32. doi: 10.1186/1471-2474-14-32.

    PMID: 23327563BACKGROUND
  • Jones BH, Thacker SB, Gilchrist J, Kimsey CD Jr, Sosin DM. Prevention of lower extremity stress fractures in athletes and soldiers: a systematic review. Epidemiol Rev. 2002;24(2):228-47. doi: 10.1093/epirev/mxf011. No abstract available.

    PMID: 12762095BACKGROUND
  • Wilkinson DM, Blacker SD, Richmond VL, Horner FE, Rayson MP, Spiess A, Knapik JJ. Injuries and injury risk factors among British army infantry soldiers during predeployment training. Inj Prev. 2011 Dec;17(6):381-7. doi: 10.1136/ip.2010.028233. Epub 2011 Apr 19.

    PMID: 21507884BACKGROUND
  • Lehr ME, Plisky PJ, Butler RJ, Fink ML, Kiesel KB, Underwood FB. Field-expedient screening and injury risk algorithm categories as predictors of noncontact lower extremity injury. Scand J Med Sci Sports. 2013 Aug;23(4):e225-32. doi: 10.1111/sms.12062. Epub 2013 Mar 20.

    PMID: 23517071BACKGROUND
  • Butler RJ, Contreras M, Burton LC, Plisky PJ, Goode A, Kiesel K. Modifiable risk factors predict injuries in firefighters during training academies. Work. 2013 Jan 1;46(1):11-7. doi: 10.3233/WOR-121545.

    PMID: 23324700BACKGROUND
  • Peate WF, Bates G, Lunda K, Francis S, Bellamy K. Core strength: a new model for injury prediction and prevention. J Occup Med Toxicol. 2007 Apr 11;2:3. doi: 10.1186/1745-6673-2-3.

    PMID: 17428333BACKGROUND
  • Larsson H, Broman L, Harms-Ringdahl K. Individual risk factors associated with premature discharge from military service. Mil Med. 2009 Jan;174(1):9-20. doi: 10.7205/milmed-d-03-7407.

    PMID: 19216293BACKGROUND
  • Bahr R. Why screening tests to predict injury do not work-and probably never will...: a critical review. Br J Sports Med. 2016 Jul;50(13):776-80. doi: 10.1136/bjsports-2016-096256. Epub 2016 Apr 19.

    PMID: 27095747BACKGROUND
  • Jones BH, Perrotta DM, Canham-Chervak ML, Nee MA, Brundage JF. Injuries in the military: a review and commentary focused on prevention. Am J Prev Med. 2000 Apr;18(3 Suppl):71-84. doi: 10.1016/s0749-3797(99)00169-5.

  • Knapik JJ, Bullock SH, Canada S, Toney E, Wells JD, Hoedebecke E, Jones BH. Influence of an injury reduction program on injury and fitness outcomes among soldiers. Inj Prev. 2004 Feb;10(1):37-42. doi: 10.1136/ip.2003.002808.

  • Parkkari J, Kujala UM, Kannus P. Is it possible to prevent sports injuries? Review of controlled clinical trials and recommendations for future work. Sports Med. 2001;31(14):985-95. doi: 10.2165/00007256-200131140-00003.

  • de la Motte SJ, Lisman P, Sabatino M, Beutler AI, O'Connor FG, Deuster PA. The Relationship Between Functional Movement, Balance Deficits, and Previous Injury History in Deploying Marine Warfighters. J Strength Cond Res. 2016 Jun;30(6):1619-25. doi: 10.1519/JSC.0000000000000850.

  • Kodesh E, Shargal E, Kislev-Cohen R, Funk S, Dorfman L, Samuelly G, Hoffman JR, Sharvit N. Examination of the Effectiveness of Predictors for Musculoskeletal Injuries in Female Soldiers. J Sports Sci Med. 2015 Aug 11;14(3):515-21. eCollection 2015 Sep.

  • Bonazza NA, Smuin D, Onks CA, Silvis ML, Dhawan A. Reliability, Validity, and Injury Predictive Value of the Functional Movement Screen: A Systematic Review and Meta-analysis. Am J Sports Med. 2017 Mar;45(3):725-732. doi: 10.1177/0363546516641937. Epub 2016 Jul 21.

  • Rhon DI, Plisky PJ, Kiesel K, Greenlee TA, Bullock GS, Shaffer SW, Goffar SL, Teyhen DS. Predicting Subsequent Injury after Being Cleared to Return to Work from Initial Lumbar or Lower Extremity Injury. Med Sci Sports Exerc. 2023 Dec 1;55(12):2115-2122. doi: 10.1249/MSS.0000000000003257. Epub 2023 Jul 27.

  • Rhon DI, Teyhen DS, Shaffer SW, Goffar SL, Kiesel K, Plisky PP. Developing predictive models for return to work using the Military Power, Performance and Prevention (MP3) musculoskeletal injury risk algorithm: a study protocol for an injury risk assessment programme. Inj Prev. 2018 Feb;24(1):81-88. doi: 10.1136/injuryprev-2016-042234. Epub 2016 Nov 24.

MeSH Terms

Conditions

Spinal InjuriesLeg Injuries

Condition Hierarchy (Ancestors)

Back InjuriesWounds and Injuries

Study Officials

  • Daniel Rhon, DSc

    Brooke Army Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Physical Therapy, Center for the Intrepid

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 18, 2016

Study Start

March 1, 2016

Primary Completion

September 19, 2018

Study Completion

November 19, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations