Leading Musculoskeletal Injury Care
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MIRROR Projects

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Posts in Research Focus 3
Body-Worn Sensors for Risk of Injury Prediction During Military Training

More than 800,000 military service members are injured each year, leading to an estimated 25 million days of limited duty annually. Musculoskeletal injuries (MSI) are the greatest threat to force readiness during both peacetime and combat operations. Although the more severe trauma during combat can lead to a significant loss of military personnel, even seemingly mild injuries during sport and exercise could contribute to a lack of readiness and poorer overall fitness. Furthermore, non-combat MSI (during physical training, tactical training, recreational activity, and sport) are endemic within the military population accounting for 85% of all MSI among United States (U.S.) military personnel. Athletic injuries are also the leading cause of disability discharge among service members (SM) in the U.S. Army, according to Physical Evaluation Board data. Thus, prevention and care of these sports and physical training injuries are top priorities for leaders in the Department of Defense (DoD).

Most sports-related MSI affect the lower limb. Forty percent of these injuries occur at the knee, making it the most common site of MSI. Specifically, soft tissue injuries are the most frequently encountered and represent 47% of all knee injuries. In the U.S., fibrocartilage, ligamentous, and tendinous integrity compromise about the knee can lead to joint instability. Knee joint instability can have short-term and/or long-term negative effects, affecting force readiness and return-to-duty/return-to-sport (RTD/RTS) decisions. Objective measures of knee stability could be used to determine those at risk for injury thus decreasing the rate of injury. In addition, objective measures of knee stability could be used throughout the rehabilitation process to determine healing and neuroadaptation of soft tissue and surrounding contractile musculature, respectively, enabling the SM to RTD/RTS without fear of re-injury and with a greater potential to achieve their pre-injury level of performance.

Effective measures of injury risk and function are urgently needed in the military and athletic populations. Traditional functional assessment tests such as the hop test and vertical drop jump tests are currently used to determine time of return to preoperative physical activity level following knee injury and used as a clinical screening tool for anterior cruciate ligament (ACL) injury, respectively. However, the sensitivity for detecting functional weaknesses, i.e. single-leg hop test for distance, is reported to be between 38-52%. It was also recently reported that none of the vertical drop jump test variables were associated with increased ACL injury risk in a cohort study of 710 athletes. Often, by the time the test results are known the functional status of the healing individual has changed or the individual has made the decision to return to activity.

The use of mobile technologies and body-worn devices for the classification of at-risk SMs with MSI can be performed in a matter of minutes with real-time analysis. Predicting which SMs are at risk for injury prior to an adverse event can have a major impact on their health, career, and the cost of care for the military.

To assess the risk for knee injury efficiently, we have previously developed a novel mobile lower limb motion capture system (known as CaneSenseTM) consisting of small wireless inertial measurement units (IMUs) that communicate via Bluetooth to a custom mobile app on a mobile tablet. Data is processed in real time and includes kinematics and kinetics to improve functional outcomes.

The Impact of a Unique Sports Medicine Model on Readiness in the Army: A Prospective Cohort Analysis on the Duration of Healthcare Management and the Incidence of Re-Injury Within 24 Months

Training room clinical models have been in use in sport at all levels for generations. This approach employs rapid initial assessment and triage by highly trained MSI treatment and rehabilitation experts (e.g. Athletic Trainers, Physical Therapists, Orthopedic surgeons and Sports Medicine physicians). These skilled providers work in concert to mitigate the secondary effects of injury and return athletes to activities as quickly/safely as possible. Traditional sports medicine models revolve around quick access to multi-disciplinary care teams including allied health providers with unique expertise in sports nutrition, strength and conditioning, and sports psychology.

In the current standard of care, healthcare providers organize operationally to allow for more patients to be seen in a shorter period of time. This model allows a multidisciplinary team to treat patients simultaneously during designated clinic hours and consult with one another on diagnoses and treatment plans—this is highly efficient for both the patient and the organization. The Sports Medicine Model is equally focused on primary injury prevention, because primary prevention is the best way to keep athletes on the field and in the game.

In contrast, the military medicine model, outside of trained combat medics who provide pre-hospital battlefield trauma care and resuscitation at point of injury during field training and combat, provides traditional problem-based clinic visits for MSI of active duty service members. Providers outside of the primary MTFs who most typically are not specialized in MSI, evaluate patients and refer them to an appropriate consultant such as a physical therapist, radiology, sports medicine trained family physician, or orthopedic surgeon. Inherent time lags between providers often delays care, which is suboptimal when treating MSI. For active duty members, these delays may result in disbarment or failures from training schools, missed deployments, and decreases in medical readiness for deployable units.

Evaluation of Video Telehealth Versus Standard Gait Retraining

Telehealth-based gait retraining has the potential to improve outcomes for Warfighters recovering from running-related injuries in remote and austere environments. Since 1992, the U.S. military has valued the use of telehealth to meet its unique obligations and missions. The goal of telehealth is to provide seamless communication of medical information between a patient and medical provider. Studies have shown statistically significant improvement in healthcare endpoints in the military as a direct result of telehealth care. Through the use of telehealth, it is possible to monitor, train, consult and inform end users in their deployed environment. It enables healthcare professionals to maintain or even improve an end user’s condition and quality of life, and at the same time reduce in-hospital and travel costs.

Forty-five percent of physical training and sports-related injuries in the military are due to running. Nearly all military service members run for physical training. Annual running injury incidence has recently been reported between 19-79%. While running-related injuries are multifactorial, average vertical loading rate has been the variable most linked to running related injury. Approximately 80% of runners use a rearfoot strike (RFS) pattern whereby the heel hits the ground first on each step. Runners using a RFS pattern have been shown to have up to 3.4 times greater risk of sustaining a running-related injury compared to runners who use a non-rearfoot strike (NRFS). Alterations in running gait, to include foot strike pattern may reduce injuries.

Recently, running with biofeedback in a lab setting has been used effectively for rehabilitation of runners recovering from patellofemoral knee pain (PFPS) and for reducing stress fracture risk. Florkiewicz et al. trained nine runners recovering from various lower-extremity injuries in 8 sessions over 10 weeks to increase cadence and transition from a RFS to a (NRFS) pattern. While gait retraining in a lab setting has been successful with the use of real-time in-clinic biofeedback, to our knowledge, this is the first research project that uses gait retraining via video telehealth to modify gait of previously injured runners.

Prospective Study to Evaluate the Validity and Predictive Ability of Physical Exam Signs for Cervical Radiculopathy to Predict Epidural Steroid Injection (ESI) Treatment Outcomes

Neck pain is one of the five most common pain conditions and leading causes of disability worldwide. According to one systematic review, the estimated mean point, annual, and lifetime prevalence rates were 7.6%, 37.2% and 48.5%, respectively. In the only study examining the breakdown of neck pain according to mechanism, approximately 50% of people with chronic neck pain had neuropathic (i.e. radicular) pain. 

Among individuals with neuropathic neck pain, epidural steroid injections (ESI) are arguably the most effective non-surgical treatment, though questions remain regarding long-term benefit. Over the past 20 years, utilization of ESI in general and cervical ESI in particular almost tripled, leading to increased scrutiny on ESI and an Food & Drug Administration (FDA) panel discussion in November 2014. Cervical ESI may be associated with significant complications including paralysis, stroke and death, which led to calls to refine patient selection.

The use of non-organic signs to predict treatment outcomes has recently experienced a resurgence in interest. In 1980, the British orthopedic surgeon Gordon Waddell published a landmark article detailing eight non-organic clinical signs in five categories that they recommended be used as part of routine surgical screening. They found that people with multiple (> three out of five) non-organic signs (a.k.a. Waddell signs) were more likely to experience negative surgical outcomes for low back pain and to be identified as “problem patients.” Whereas subsequent studies have yielded mixed results for the ability of non-organic signs to predict low back pain treatment outcomes, these studies have generally been of poor quality, and until recently did not evaluate non-surgical interventional treatment outcomes (e.g. ESI). However, last year our group performed the first prospective study showing that non-organic signs were strongly correlated to low back pain (LBP) interventional treatment failure, including for lumbar ESI.

The main objectives of this study are to determine whether physical exam signs, including non-organic signs, predict cervical ESI outcomes; to validate the non-organic signs being published by determining their association with factors that may be associated with non-organic illness including psychopathology, secondary gain, and co-existing pain conditions; and to determine the prevalence of the various physical exam signs, including the non-organic signs, in patients with cervical radiculopathy.

Randomized, Placebo-controlled Crossover Trial Evaluating Topical Lidocaine Patch(es) for Mechanical Neck Pain

Neck pain is one of the 5 most common pain conditions and leading causes of disability worldwide. According to one systematic review, the estimated mean point, annual, and lifetime prevalence rates were 7.6%, 37.2% and 48.5%, respectively. In the Global Burden of Disease 2010 study, neck pain was ranked as the fourth most common cause of disability in the United States.

Among individuals with chronic neck pain, injections work for only a small percentage of patients and their effects are generally short-lived, while studies evaluating the long-term effectiveness of surgery are mixed. Among randomized, placebo-controlled trials evaluating medications for chronic neck pain, only topical diclofenac has been shown to be effective, suggesting that muscles and other superficial tissues play an important role.

Topical local anesthetics have been shown in randomized trials to alleviate some forms of neck pain (trapezius muscle) associated with myofascial trigger points, but a well-designed placebo- controlled trial found no evidence of efficacy for low back pain. This suggests that the pain generators in the neck may be more superficial than in the low back. The erector spinae and deep intrinsic muscles in the low back generally lie several inches beneath the surface, while the penetration of topical lidocaine is typically limited to around 1 cm without penetration enhancers.

A drawback of topical local anesthetic creams is that they can adhere to clothing, making absorption unreliable. They may also be messy and, on exposed skin, unsightly. This has led to the widespread adoption of topical local anesthetics embedded in patch form. Limitations of the current, commercially available formulations of topical lidocaine patches (Lidoderm, Endo Pharmaceuticals, Chadds Ford, PA) include poor bioavailability, estimated at 3%, and poor adherence. A newer formulation of topical lidocaine (ZT Lido, Scilex, San Diego, CA) that contains higher bioavailability (36 mg provides equivalent exposure to 700 mg of Lidoderm) and less variability, along with better adherence (> 90% adherence in 75% of individuals at 12 hours vs. 13.6% for Lidoderm), was recently approved for post-therapeutic neuralgia. A high adherence rate is necessary to maximize benefit in a physically active (i.e. military and VA population) cohort.

In this randomized, double-blind, placebo-controlled crossover study, patients with non-radicular neck pain will be allocated in a 1:1 ratio to receive up to three topical lidocaine or placebo patches, to be applied 12 hours per day. At the end of four weeks, patients will return for their post-phase I treatment evaluation. One to two weeks after the initial treatment, patients will crossover to receive the treatment they did not receive originally, to be applied in the same fashion for the same 4-week period. The primary outcome measure will be average neck pain over the past week, 4 weeks post-treatment.

A Sequenced Strategy for Improving Outcomes in People with Knee Osteoarthritis Pain (SKOAP)

Knee osteoarthritis (KOA) is one of the leading causes of chronic pain and disability worldwide, affecting over 30% of older adults. It represents a major global health and economic burden to individuals and society. The rates of KOA have more than doubled in the past 70 years and continue to grow sharply, given increases in life expectancy and population body mass index (BMI). Surgery is often employed to treat KOA, but it is associated with a high rate of persistent pain and is not a permanent solution. 

Numerous nonsurgical therapies have been advocated to treat pain in patients with KOA. However, standalone conservative treatments including non-opioid medications and joint injections provide only limited pain relief and functional improvement in a subset of knee OA sufferers. This has led to a high rate of opioid use and disability in this population. 

The overarching goal of this study is to conduct a sequential parallel group randomized controlled trial (RCT) to evaluate the comparative effectiveness of conservative behavioral and non-opioid pharmacological treatments (Phase 1) and, among those that indicate interest in obtaining further treatment and those inappropriate for conservative treatment, the benefits of procedural interventions (Phase 2). This study will also evaluate whether clinical and psychosocial phenotypes predict short- and longer-term treatment response. 

The results of this study, which will follow pragmatic principles in order to maximize the information provided to stakeholders, will examine not only the effectiveness of each tested intervention but also provide meaningful information regarding effectiveness across key subgroups of participants. The knowledge gained will contribute to the development of translatable therapeutic strategies for the treatment of KOA pain that will lead to opioid sparing.

Open versus Arthroscopic Stabilization of Shoulder Instability with Subcritical Bone Loss (OASIS Trial)

Military personnel are the most at-risk population for shoulder instability and more than 80% of these individuals have recurrent instability with non-operative treatment. Traumatic and recurrent shoulder instability produces progressive bone loss to the stabilizing structures of the glenoid and humerus, which contributes to failure following surgery, impairments of physical performance, and prolongs limited duty/disability. To date, there are no prospective comparative studies to determine optimal surgical treatment for shoulder instability with subcritical glenoid bone loss (10-20%). Further, there are no studies to assess functional recovery and return to military duty, work, and sports after the most common stabilization procedures. Therefore, this clinical trial will investigate the effects of three surgical procedures and the associated post-operative rehabilitation to mitigate the risk of re-injury, minimize time away from duty, and optimize military readiness.

This study will recruit military personnel and civilians between 17 and 45 with a traumatic anterior shoulder dislocation with associated 10-20% bone loss and randomize to one of three surgeries and their associated rehabilitation, with progressive-individualized strengthening and functional training in a 1:1:1 allocation. Participants will be followed for 24 months, with primary outcomes consisting of patient-reported physical function and time to return to pre-injury military duty, work, and sports. Secondary outcomes will include shoulder-specific and generic patient-reported measures of physical function, health/quality of life, and recurrent instability.

Low-Back Pain-Related Healthcare Utilization Patterns for Upper and Lower Extremity Amputees

The goal of this study is to identify and develop a syntax of ICD (diagnosis) and CPT (procedures) codes that are able to accurately identify amputees in the MHS, and all LBP-related care, describe and characterize the amputee patient population with low back pain, and calculate the total 1-year LBP-related costs in the year following the initial index visit for LBP.