This study will provide critical MSI surveillance by developing a standardized, service-wide epidemiological report which will be used to understand the frequency and prevalence of injuries in the military. Data will be published quarterly and distributed to key stakeholders and sponsors to identify clinical and operational gaps in care.
WTU patient populations have changed in response to the nature of modern warfare and its intrinsic risks. As the needs of the Army and active combat operations have evolved over the past 10 years, the types of injuries and illnesses sustained by soldiers entering the WCTP have also changed, with the majority of entrants now falling into a disease NBI category. At present, there are fourteen WTUs co-located with MTFs, which reflects a >40% reduction in WTUs from the height of the program. Although military operations in Iraq and Afghanistan have declined significantly, resulting in fewer wounded warriors returning home and a decline of the WCTP population (currently around 2,600 soldiers), the Army is committed to supporting and caring for transitioning soldiers and their families, and remains flexible to changes in the future population.
Once facet joint pain has been diagnosed clinically, the current interventional treatment options for prolonged relief includes corticosteroid (CSI) injection of the facet joint or radiofrequency ablation of the medial branch nerves. There are variable evidence to the effectiveness of the corticosteroid injection of the lumbar facet joints, with a systemic review showing Level III evidence of trials with short term effectiveness less than 6 months. The evidence for radiofrequency ablation is more robust with Level 1 evidence for effectiveness less than 6 month and Level 2 evidence for effectiveness greater than 6 months (Manchikanti L. et al. Pain Physician Jul/Aug 2015; 19:E535-582; Rajni Vekaria et al. Eur Spine J 2016 25:1266-1281). There are also studies that have suggested similar effectiveness of intra-articular facet joint injection and radiofrequency ablation. Other clinical providers have evaluated autologous use of biological material to treat facet mediated pain including platelet rich plasma (PRP), to accelerate healing of a degenerative tissue. (Wu J et al. Pain Physician 2016 Nov-Dec 19; 19(8); 617- 625). A new techniques for the treatment of lumbar facet joint syndrome using intra-articular injection with autologous platelet rich plasma.
Novel treatment methods for treating facet pain are sorely needed since CSI treatments have reported risks associated with injection, osteoporosis, accelerated degeneration, avascular necrosis, and suppression of endogenous corticosteroid production. Further, the long-term consequence of ongoing radiofrequency ablation treatment has not been fully elucidated. While radiofrequency ablation (RFA) temporarily denervates the medial branch that provides the sensation to the facet joint, RFA also denervates parts of paraspinal muscles, which can potentially cause weakness and further slow rehabilitation.
The use of orthobiologics and concepts behind regenerative therapy has gained increased traction as a way to treat musculoskeletal issues. PRP is an autologous source of blood product that contains higher platelet concentration after being prepared in a centrifuge. It is thought that the higher level of growth factors (such as PDGF, TGF-B, VEGF< EGF, bFGF< IGF-1) and cytokines released by the platelets promote a healing cascade. Preclinical and clinical studies have investigated use of PRP on treating various structures including tendons, ligaments and joints. While these trials have shown promising results there continues to be lack of high quality studies.
In order to improve the rehabilitation of service members with LBP, novel trials that include PRP must be studied. Although early clinical evidence suggests that PRP therapy may improve outcomes without destruction of tissues, to date, no randomized single blinded placebo-controlled study to look at the effectiveness of PRP injection for lumbar facet mediated joint pain exists.
The study will provide evidence-based medicine on a new regenerative medicine treatment option that may affect significant military personnel with LBP. PRP may offer alternate treatment methods that may help preserve the facet joint structures, improve pain and function without causing destructive lesions or worsening degenerative joints. This healing process may favor improved participation with rehabilitation therapy and ultimately improve return to duty status. This study will also assess the effectiveness of point of care generated PRP, as a minimally invasive treatment option for treating lumbar facet pain. Specifically, PRP effectiveness will be compared to injecting placebo control when injected into facet joints.
Chronic exertional compartment syndrome (CECS) is a debilitating disorder affecting mostly an active population. The proposed pathophysiology is increased pressure in muscle compartments causing pain, paresthesia, and inability to tolerate exercise in the affected fascial compartment. CECS involves the lower extremities, primarily affects young active adults, and limits running and/or endurance activities. While the incidence of CECS in the general population is unknown, the prevalence in the military population has been found to be 0.49 cases per 1000 patient-years.
The current standard for definitive treatment of CECS is surgical fasciotomy of the involved compartments. According to a 2016 systematic review, surgical intervention for CECS is successful in only 66% of those affected, with 13% of patients reporting complications from surgery, and 6% needing a repeat procedure. A 2014 retrospective review of military members showed that only 59% of patients who underwent elective fasciotomy for CECS were able to return to full duty while 22% of the patients that were treated with fasciotomy were eventually medically discharged. One of the reasons for the limited success rate, is an incomplete understanding of the pathophysiology coupled with proper patient selection.
Gait retraining is an attractive alternative to fasciotomy. It aims to influence the effect of foot contact and running kinematics to reduce leg compartment pressures which relieves pain. Diebal et al. published a case series of 10 military members with CECS who underwent a gait retraining program that emphasized forefoot running. At six-weeks and one-year post-intervention, running distance, pain, and performance all significantly improved. Despite high rates of success in limited case studies, real world application of gait retraining has limitations. Many patients struggle to make and/or sustain adaptations in their running style. Some patients have severe pain with exercise which limits efforts at effective gait re-training.
A newer proposed treatment is the intramuscular administration of onabotulinumtoxin A, also known as botulinum toxin A or BoNT-A into the muscles of the involved compartment(s). One case series studying botulinum toxin injections for CECS demonstrated normalized intramuscular pressure up to nine months post-injection in 87.5% (14/16) of patients, and exertional pain was completely eliminated in 94% (15/16) of patients.81 Eleven patients experienced reduced muscle strength that was without functional consequences and transient, with only 1 of the 16 patients who complained of new posterior leg pain that did not appear to be related to BoNT-A injections. There were no other adverse effects reported.
Military sports medicine clinics at Fort Belvoir Community Hospital (FBCH) and USU have been utilizing BoNT-A injections for the non-surgical treatment of CECS. A retrospective review of patients with CECS treated with BoNT-A at FBCH Sports Medicine Clinic from 2014 to 2017 provided data on twenty-nine patients who were treated with BoNT-A for CECS. Prior to treatment, none of the 29 patients were able to perform their desired activity and 24% were unable to run one mile without severe leg pain. After botulinum injections, these numbers improved to 66% and 72% respectively. Sixty-nine percent of patients reported that they were satisfied or somewhat satisfied with their treatment, twelve patients continued to have sustained relief by the time they were contacted, and seven patients experienced a recurrence of symptoms. In those with recurrence, the mean duration of improvement was 7.8 months. Of note, 11 patients received both BoNT-A and fasciotomy during their treatment course. Only one patient reported a favorable response to fasciotomy and failure with BoNT-A, suggesting that BoNT-A injections might be predictive of success with fasciotomy.
BoNT-A is FDA approved for intramuscular, intradetrusor, or intradermal use for muscle spasticity, migraine headaches, detrusor instability and severe forehead lines, lateral canthal lines, and glabellar lines in adults. To avoid side effects and predict treatment success, a recent published case review of pre-treatment with xylocaine injections prior to proposed BoNT-A injection for frontalis and glabellar rhytides was issued. Further, a yet unpublished case using the pre-treatment xylocaine protocol was conducted at FBCH. The subject improved her running symptoms with the xylocaine injection and subsequently underwent BoNT-A treatment. One month after the BoNT-A she is able to now walk/run up to 1 mile with no exertional symptoms.
The purpose of this grant application is to create a registry across all MTFs for CECS to compare diagnostic and therapeutic data. We will simultaneously assess the effectiveness of non-surgical treatments options for chronic exertional compartment syndrome as well as test the use of xylocaine injections to predict success for non-surgical or surgical options at selected sites. This study will also determine if successful gait retraining, either home based or supervised, is essential to positive results Furthermore this study will also determine if BoNT-A injections plus gait retraining is better than either treatment alone. Finally, this study would determine if xylocaine injections could predict who will benefit from BoNT-A injections or fasciotomy.
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