Post-Concussion Musculoskeletal Injury Risks

Recruiting now

Conditions studied: Musculoskeletal Injury

In brief

Musculoskeletal injuries (MSKI) and traumatic brain injury (TBI) are the signature injuries of the ongoing military conflicts. MSKI affect 800,000 Service Members annually and TBI have impacted more than 350,000 in the past 19 years and account for 22% of all combat casualties. Concussion, a mild form of TBI, increases MSKI risk in physically active individuals, including Service Members. The overall goal of the study is to identify the neuromuscular control mechanisms that increase MSKI risk following concussion. It is hypothesized that concussed individuals will display abnormal neuromuscular function that increases MSKI risk, as compared to non-concussed controls. The study will employ a multi-center, prospective, case-matched control observational study to identify the differences in neuromuscular function following concussion that may contribute to increased MSKI risk. Once the neuromuscular control mechanisms that increase MSKI risk following concussion are identified, targeted risk mitigation strategies can be developed to reduce MSKI risk.

Key facts

Study ID

NCT05122728

Run by

Walter Reed National Military Medical Center

People needed

148

Starts

2022-10-20

Expected to finish

2027-09-30

Last updated by the study team

2026-01-27

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Concussed Cohort
• 18-40 years old.
• Self-reported asymptomatic post-concussion following enrollment into the study and monitoring of symptoms by research personnel via daily self-reported symptom questionnaires.
• Recruited within 5 days following being diagnosed with a concussion, and at least 72 hours prior to self-reporting as asymptomatic.
• Access to a functional email address and the internet for completion of patient reported outcomes (PROs) and musculoskeletal injury measures.
• Non-Concussed Cohort
• 18-40 years old.
• Active duty Service members and physically active civilians.
• No self-report history of concussion within the previous 5 years.
• No lingering post-concussion signs/symptoms.
• Same gender as the matched concussed participant.
• Within ±5% of the matched concussed participant's height, weight, and body mass index.
• Within ±2 years of age of the matched concussed participant.
• Participant in the same physical activities (work, recreational sports, average type [no impact, low-impact, high-impact] and duration of physical activity)

You may not qualify if…

• Post-Concussion Cohort AND Healthy Non-Concussed Cohort
• Unable to read or comprehend the English language.
• Admitted to the hospital following concussion.
• Sustained a concussion not related to physical activity participation (e.g., blast-related injury, fall from a ladder, motor vehicle accident).
• Loss of consciousness longer than 30 minutes.
• Alteration in consciousness longer than 24 hours.
• Post-traumatic amnesia lasting longer than 1 day.
• Glasgow Coma Scale below 13.
• Abnormal brain imaging findings.
• Sustained a concussion that took longer than 21 days for the individual to report as asymptomatic.
• A MSKI within the last 6 months that resulted in altered or missed physical activity for 3 or more consecutive days.
• History of MSKI surgery.
• Pregnant females (will be eligible for participation in the study once medically cleared to RTD/A by a qualified and licensed healthcare provider following the end of the pregnancy).
• Participants will be excluded if they present any known contraindications for electrical stimulation. These contraindications include conditions such as: active deep vein thrombosis/thrombophlebitis, any acute injury with concurrent inflammation, hemorrhagic conditions, impaired circulation, impaired local sensations, presence of infection (osteomyelitis, tuberculosis), malignancy, recently radiated tissue, skin disease/damage and/or at-risk skin.
• Present with any implanted pacemaker, electronic device, or plastic/cement material

Where it is running

• University of Georgia — Athens, Georgia, United States (enrolling)
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States (enrolling)
• Womack Army Medical Center — Fort Bragg, North Carolina, United States

Full record on ClinicalTrials.gov

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