Musculoskeletal InjuryMP3-RDNCT02776930
Predictive Models for Spine and Lower Extremity Injury After Discharge From Rehab
An observational study of Musculoskeletal Injury and Spinal Injuries, run by Brooke Army Medical Center at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Musculoskeletal Injury, Spinal Injuries, Leg Injuries
- How many people
- 480 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2016to 19 Nov 2019
- Phase
- Observational
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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or recently pregnant within the last 6 months - subjects that become pregnant during the course of the study will be withdrawn based on the different injury risk factors that are associated with pregnancy.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
William Beaumont Army Medical Center
Fort Bliss, Texas, 79920
Womack Army Medical Center
Fort Bragg, North Carolina, 28307
Brooke Army Medical Center
San Antonio, Texas, 78234
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: Development of Predictive Models for Lower Extremity, Lumbar, and Thoracic Injury After Discharge From Physical Rehabilitation
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.
Read the detailed description
Subjects will be recruited across 4 medical centers after having completed a regimen of physical therapy for a spine or lower extremity injury. Upon discharge back to full duty, they will be given the opportunity to enroll in the study and undergo a battery of physical performance tests and associated surveys. The subjects will then be followed for a year to identify the occurrence of any injuries. Prediction algorithms will be derived using regression analysis to predict injury based on performance on the physical evaluation tests.
The overall hypothesis is that Service Member performance on a battery of physical performance tests performed upon discharge from care and return to duty, will be able to predict 1) the risk of sustaining any injury as well as 2) reoccurrence of the same injury that they were seeking care for during the year following discharge from rehabilitation. The current assumption is that when a Service Member is discharged from medical care, it has been done based on the expectation that it is appropriate and safe for them to return to function in their operational environment. Because history of prior injury is a well-established risk factor, every single Service Member that is returned to duty after medical care for a musculoskeletal (MSK) injury is already at a higher risk for future injury than his or her non-injured counterpart. The investigators hypothesize that decreased performance on the proposed testing protocol will be related to increase in the risk of 1 year-injury and recurrence of injury. Successfully identifying those at increased risk of recurrence provides the ability for secondary and tertiary prevention programs to optimize return to duty rates. Injury will be defined as any new musculoskeletal injury or the re-occurrence of the same injury during the 1-year surveillance period.
The battery of physical performance tests will include: Selective Functional Movement Assessment (SFMA), Functional Movement Screen (FMS), Upper Quarter Y-balance Test (YBT-UQ), Lower Quarter Y-balance Test (YBT-LQ), Closed Kinetic Chain Dorsiflexion (CKC DF), a Single Hop Test, Triple Hop Test, Triple Crossover Hop Test, Carry Test, and a un-weighted and weighted 300 yard Shuttle Run Test.
Each subject will then also be contacted monthly via a SMS (Short Message Service, e.g. text message) survey for the following year to identify information about additional injury or profile that they may have sustained during the prior period of time. Information about injury will also be calculated from patient chart reviews and Department of Defense healthcare utilization database (claims data). This will provide a robust method in which to capture data injury data regardless of subject availability for follow-up.
Subjects will be dichotomized as injured or non-injured based on the injury surveillance data. Key demographic, physical performance (FMS, YBT, SFMA, Hop Test, Carry test, \& Shuttle Run), and self-report measures will be examined for group differences. Potential predictor variables will be entered into a backward stepwise logistic regression model to determine the most accurate set of variables predictive of musculoskeletal injury status.
Risk stratification (low, moderate, or high) will be based on likelihood ratios (LR) associated with the clinical prediction rule for injury outlined above. A positive LR > 10 will place the individual as high risk, a LR between 2 and 10 would place the individual as moderate risk. Those with a positive LR less than 2 will be listed as low risk.
- Conditions
- Musculoskeletal Injury, Spinal Injuries, Leg Injuries
- Keywords
- Injury Prediction, Return to Work, Injury Prevention
- Medical subject headings
- Spinal Injuries, Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury Occurrence
Monthly SMS survey capturing new musculoskeletal injury since the prior survey
Measured: 1 year
Secondary outcomes (1)
Injury-Related Healthcare Utilization
Healthcare utilization for musculoskeletal injury taken from the Tricare claims database (MHS Data Repository)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startMar 2016
- Primary completion19 Sep 2018
- Study completion19 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Womack Army Medical Center, William Beaumont Army Medical Center, Madigan Army Medical Center
- Responsible party
- Principal investigator, Dan Rhon, Brooke Army Medical Center
- Investigators
- Daniel Rhon, DSc, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776930
- Sponsor's protocol ID
- 215032
- Acronym
- MP3-RD
- Status last verified
- Jan 2020
- First submitted
- 17 May 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Data sharing must be requested and approved through the Defense Health Agency via a Data Sharing Agreement Application
Publications
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.
PubMed 12441574Ernat 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.
PubMed 23198512Knapik 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.
PubMed 23327563Jones 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.
PubMed 12762095Wilkinson 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.
PubMed 21507884Lehr 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.
PubMed 23517071Butler 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.
PubMed 23324700Peate 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.
PubMed 17428333Larsson 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.
PubMed 19216293Bahr 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.
PubMed 27095747Jones 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.
PubMed 10736543Knapik 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.
PubMed 14760025Parkkari 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.
PubMed 11735682de 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.
PubMed 26964060Kodesh 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.
PubMed 26336337
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Predictive Models for Lower Extremity, Lumbar, and Thoracic Injury After Discharge From Physical Rehabilitation
- ClinicalTrials.gov ID
- NCT02776930
- Acronym / sponsor ID
- MP3-RD / 215032
- Conditions
- Musculoskeletal Injury, Spinal Injuries, Leg Injuries
- Keywords
- Injury Prediction, Return to Work, Injury Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- Womack Army Medical Center, William Beaumont Army Medical Center, Madigan Army Medical Center
- Study start
- Mar 2016 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects will be recruited across 4 medical centers after having completed a regimen of physical therapy for a spine or lower extremity injury. Upon discharge back to full duty, they will be given the opportunity to enroll in the study and undergo a battery of physical performance tests and associated surveys. The subjects will then be followed for a year to identify the occurrence of any injuries. Prediction algorithms will be derived using regression analysis to predict injury based on performance on the physical evaluation tests.
The overall hypothesis is that Service Member performance on a battery of physical performance tests performed upon discharge from care and return to duty, will be able to predict 1) the risk of sustaining any injury as well as 2) reoccurrence of the same injury that they were seeking care for during the year following discharge from rehabilitation. The current assumption is that when a Service Member is discharged from medical care, it has been done based on the expectation that it is appropriate and safe for them to return to function in their operational environment. Because history of prior injury is a well-established risk factor, every single Service Member that is returned to duty after medical care for a musculoskeletal (MSK) injury is already at a higher risk for future injury than his or her non-injured counterpart. The investigators hypothesize that decreased performance on the proposed testing protocol will be related to increase in the risk of 1 year-injury and recurrence of injury. Successfully identifying those at increased risk of recurrence provides the ability for secondary and tertiary prevention programs to optimize return to duty rates. Injury will be defined as any new musculoskeletal injury or the re-occurrence of the same injury during the 1-year surveillance period.
The battery of physical performance tests will include: Selective Functional Movement Assessment (SFMA), Functional Movement Screen (FMS), Upper Quarter Y-balance Test (YBT-UQ), Lower Quarter Y-balance Test (YBT-LQ), Closed Kinetic Chain Dorsiflexion (CKC DF), a Single Hop Test, Triple Hop Test, Triple Crossover Hop Test, Carry Test, and a un-weighted and weighted 300 yard Shuttle Run Test.
Each subject will then also be contacted monthly via a SMS (Short Message Service, e.g. text message) survey for the following year to identify information about additional injury or profile that they may have sustained during the prior period of time. Information about injury will also be calculated from patient chart reviews and Department of Defense healthcare utilization database (claims data). This will provide a robust method in which to capture data injury data regardless of subject availability for follow-up.
Subjects will be dichotomized as injured or non-injured based on the injury surveillance data. Key demographic, physical performance (FMS, YBT, SFMA, Hop Test, Carry test, \& Shuttle Run), and self-report measures will be examined for group differences. Potential predictor variables will be entered into a backward stepwise logistic regression model to determine the most accurate set of variables predictive of musculoskeletal injury status.
Risk stratification (low, moderate, or high) will be based on likelihood ratios (LR) associated with the clinical prediction rule for injury outlined above. A positive LR > 10 will place the individual as high risk, a LR between 2 and 10 would place the individual as moderate risk. Those with a positive LR less than 2 will be listed as low risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Injury Occurrence
Time frame: 1 year
Monthly SMS survey capturing new musculoskeletal injury since the prior survey
1 secondary outcome
Injury-Related Healthcare Utilization
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Background: PubMed 12441574Lincoln 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.
- Background: PubMed 23198512Ernat 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.
- Background: PubMed 23327563Knapik 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.
- Background: PubMed 12762095Jones 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.
- Background: PubMed 21507884Wilkinson 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.
- Background: PubMed 23517071Lehr 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.
- Background: PubMed 23324700Butler 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.
- Background: PubMed 17428333Peate 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.
- Background: PubMed 19216293Larsson 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.
- Background: PubMed 27095747Bahr 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.
- Results publication: PubMed 10736543Jones 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.
- Results publication: PubMed 14760025Knapik 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.
- Individual participant dataSharing planned: Undecided. Data sharing must be requested and approved through the Defense Health Agency via a Data Sharing Agreement Application
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Rhon, DSc principal investigator
Brooke Army Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Injury and Spinal Injuries, run by Brooke Army Medical Center at 4 sites in United States.
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 3 inclusion and 3 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Injury Occurrence (time frame: 1 year). 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 NCT02776930, which also lists 18 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 18 Jan 2020.