A Sequential Multiple-Assignment Randomized Trial (SMART) for Stepped Care Management of Low Back Pain in the Military Health System: A Trial Protocol

Fritz, Julie M.; Rhon, Daniel I.; Teyhen, Deydre S.; Kean, Jacob; Vanneman, Megan E.; Garland, Eric L.; Lee, Ian E; Thorp, Richard E; Greene, Tom

doi:10.1093/pm/pnaa338

Cited by 12 publications

(11 citation statements)

References 48 publications

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“…Previously, numerous studies have explored the risk factors and prevention strategies for military LBP, from the Prevention of Low Back Pain in the Military (POLM) trials in 2007 to the very recent Resolving the Burden of Low Back Pain in Military Service Members and Veterans (RESOLVE) and Sequential Multiple-Assignment Randomized Trial (SMART) programs ( 8 , 9 ). According to these results, prior history of LBP, previous musculoskeletal injury, less time in physical training, female sex, and lower rank were consistent risk factors for LBP in active-duty personnel, noting that these risk factors are significantly different from those of the general population and even for veterans ( 10 ).…”

Section: Introductionmentioning

confidence: 99%

Comparative effectiveness of electroacupuncture VS neuromuscular electrical stimulation in the treatment of chronic low back pain in active-duty personals: A single-center, randomized control study

Meng

Chen

et al. 2022

Front. Neurol.

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IntroductionLow back pain (LBP) is the most prevalent form of chronic pain in active-duty military personnel worldwide. Electroacupuncture (EA) and neuromuscular electrical stimulation (NMES) are the two most widely used treatment methods in the military, while evidence for their benefits is lacking. The aim of this randomized clinical trial is to investigate the effectiveness of EA vs. NMES in reducing pain intensity among active-duty navy personals with chronic LBP.MethodsThe study is designed as a single-center, randomized controlled trial. The primary outcome is a positive categorical response for treatment success in the first-time follow-up, which is predesignated as a two-point or greater decrease in the NRS score and combined with a score > 3 on the treatment satisfaction scale. The secondary outcomes include pain intensity, rate of treatment success, and Oswestry Disability Index (ODI) fear-avoidance beliefs questionnaire (FABQ) score along with muscular performance. The first follow-up starts on the first day after completing the last treatment session, and then the 4-weeks and 12-weeks follow-up are applied via telephone visit.ResultsEighty-five subjects complete the treatment diagram and are included in the analysis. For the primary outcome, no difference has been found between EA and NMES, with 65.1% (28 in 43) individuals reporting a positive response to EA treatment, while 53.5% (23 in 43) in NMES. However, for longer follow-ups, superiority in positive response of EA has been found in 4-weeks (26 in 39, 66.7% vs. 16 in 40, 40%; P = 0.018) and 12-weeks (24 in 36, 66.7% vs. 12 in 36, 33.3%; P = 0.005) follow-up. In the regression analysis, baseline pain intensity and FABQ score are identified to be highly associated with positive treatment outcomes. Finally, the subgroup analysis suggests that EA treatment is associated with better long-term outcomes in patients with LBP with a severe pain score (NRS score >4, Figure 4B) and stronger fear-avoidance beliefs.ConclusionBoth the EA and NMES are associated with a positive response in treating military LBP, and the former offers lasting benefits in the later follow-ups. Thus, electroacupuncture is a more recommended treatment for military LBP. A lot of research is needed to verify an efficient and standardized treatment session, with more information and evidence about indications for these treatments.Trial registrationChiCTR, (ChiCTR2100043726); registered February 27, 2021.

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Section: Introductionmentioning

confidence: 99%

Comparative effectiveness of electroacupuncture VS neuromuscular electrical stimulation in the treatment of chronic low back pain in active-duty personals: A single-center, randomized control study

Meng

Chen

et al. 2022

Front. Neurol.

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“…Nesse sentido, seria interessante um programa de exercícios físicos por orientação de um profissional da área, objetivando o fortalecimento muscular da região do abdômen, lombar, pelve e quadril, visto que tanto a ausência quanto o excesso de esforço físico podem ocasionar danos à mecânica do indivíduo 6,19 . É importante ressaltar um estudo de intervenção realizado na cidade de Curitiba, no estado do Paraná, com 42 PMs (homens), que, entre os objetivos, buscou verificar o efeito da adoção da posição de Fowler durante 20 minutos ao término da jornada de trabalho na recuperação da estatura e identificou uma recuperação significante na estatura dos PMs.…”

Section: Discussionunclassified

Perception of lower back pain associated with use of body armor in police officers of the countryside specialized battalion of Ceará, Brazil

Souza¹,

Albuquerque²,

Alves³

et al. 2023

Rev Bras Med Trab

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As rigorosas exigências do ambiente militar associadas ao aumento da violência, bem como ao uso frequente do colete balístico, podem agravar ainda mais os problemas de saúde. Objetivos: Investigar a associação do uso de colete balístico em relação ao conforto, à fadiga e à queixa de lombalgia em policiais do batalhão especializado do Ceará. Métodos: Tratouse de um estudo transversal realizado com 260 policiais militares do sexo masculino (34,62 ± 5,83 anos) pertencentes ao batalhão de policiamento ostensivo rural do estado do Ceará. O questionário relacionado a conforto, fadiga e dores na região lombar foi utilizado para identificar a percepção de dor pelo uso do colete balístico, com respostas escalonadas, e seus resultados foram analisados no software SPSS 21.0. Resultados: Quanto ao uso do colete, 41,5% perceberam ser pouco confortável no geral; e 45 e 47,5% dos policiais militares consideraram ser pouco confortável em relação ao peso e em relação ao uso durante as atividades operacionais, respectivamente. No que se refere às medidas corporais, 48,5% reportaram ser confortável, e 70% percebem o colete como ajustável ao corpo. No momento da finalização do turno de trabalho, 37,3% apresentam dores na região lombar e 45,8% sentem fadiga moderada. Após o encerramento do turno de trabalho, 70,1% sentem dores na região lombar. Conclusões: Os policiais militares perceberam dores na região lombar ao final e depois do turno de trabalho pelo uso do colete balistico, além de relatarem sobre o pouco conforto do equipamento de proteção e sobre a fadiga moderada ao fim do turno de trabalho. Palavras-chave | polícia; saúde do trabalhador; trabalho; dor lombar. ABSTRACT | Introduction:The strict demands of the military environment, associated with the increase in violence, as well as the frequent use of body armor, can further aggravate health problems. Objectives: To investigate the perception of police officers of the Countryside Specialized Police Battalion in relation to comfort, fatigue, and lower back pain, resulting from the use of body armor. Methods: This was a cross-sectional study conducted with 260 male military police officers (34.62 ± 5.83 years old) belonging to the ostensive rural police battalion in the state of Ceará, Brazil. The questionnaire related to comfort, fatigue, and lower back pain was used to identify the perception of pain from the use of body armor, with staggered responses, and the results were analyzed using the SPSS 21.0 software. Results: Regarding the use of body armor, 41.5% of participants perceived it to be little comfortable in general; furthermore, 45 and 47.5% of military police officers considered it little comfortable in relation to weight and use during operational activities, respectively. With regard to body measurements, 48.5% reported being little comfortable, and 70% perceived that the body armor is adjustable to the body. At the end of the work shift, 37.3% complained of lower back pain, and 45.8% felt moderate fatigue. Moreover, 70.1% felt pain in the lower back after the wo...

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“…The M2H program for chronic LBP was operationalized at a more detailed and condition-specific level than the overall M2H program in order to facilitate implementation. The tools presented in this manuscript provide the core materials and framework necessary to deliver the intervention in the PMC trial [ 27 ]. Tools will vary by setting, health system, and specific medical condition, thus efforts to implement the M2H program should make modifications as appropriate.…”

Section: Discussionmentioning

confidence: 99%

“…The Collaboratory is an unprecedented effort of federal agencies to build capacity for large-scale pragmatic clinical research in the MHS and VHA focused on improving pain management through nonpharmacologic care. Our team’s clinical trial investigates the implementation of pragmatic, first-line treatment strategies for chronic LBP in the MHS including M2H as an intervention arm [ 27 ]. Developing the study protocol required operationalizing M2H for chronic LBP around the key components outlined above (using a PHI and goal setting, developing management algorithms for collaborative care between traditional and CIH and population health resources, and facilitating self-management).…”

Section: Introductionmentioning

confidence: 99%

Move to health-a holistic approach to the management of chronic low back pain: an intervention and implementation protocol developed for a pragmatic clinical trial

et al. 2021

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Background The prevalence of chronic pain conditions is growing. Low back pain was the primary cause of disability worldwide out of 156 conditions assessed between 1990 and 2016, according to the Global Burden of Disease Study. Conventional medical approaches have failed to identify effective and long-lasting approaches for the management of chronic pain, and often fail to consider the multiple domains that influence overall health and can contribute to the pain experience. Leading international organizations that focus on pain research have stated the importance of considering these other domains within holistic and multidisciplinary frameworks for treating pain. While the research behind the theoretical link between these domains and chronic pain outcomes has expanded greatly over the last decade, there have been few practical and feasible methods to implement this type of care in normal clinical practice. Methods The purpose of this manuscript is to describe an implementation protocol that is being used to deliver a complex holistic health intervention at multiple sites within a large government health system, as part of a larger multisite trial for patients with chronic low back pain. The Move to Health program developed by the US Army Medical Command was tailored for specific application to patients with low back pain and begins by providing an empirical link between eight different health domains (that include physical, emotional, social, and psychological constructs) and chronic low back pain. Through a six-step process, a health coach leverages motivational interviewing and information from a personal health inventory to guide the patient through a series of conversations about behavioral lifestyle choices. The patient chooses which domains they want to prioritize, and the health coach helps implement the plan with the use of SMART (Specific, Measurable, Attainable, Realistic, Time-bound) goals and a series of resources for every domain, triaged from self-management to specialist referral. Discussion Complex interventions described in clinical trials are often challenging to implement because they lack sufficient details. Implementation protocols can improve the ability to properly deliver trial interventions into regular clinical practice with increased fidelity. Trial registration Implementation of this intervention protocol was developed for a clinical trial that was registered a priori (clinicaltrials.gov #NCT04172038).

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A Sequential Multiple-Assignment Randomized Trial (SMART) for Stepped Care Management of Low Back Pain in the Military Health System: A Trial Protocol

Cited by 12 publications

References 48 publications

Comparative effectiveness of electroacupuncture VS neuromuscular electrical stimulation in the treatment of chronic low back pain in active-duty personals: A single-center, randomized control study

Comparative effectiveness of electroacupuncture VS neuromuscular electrical stimulation in the treatment of chronic low back pain in active-duty personals: A single-center, randomized control study

Perception of lower back pain associated with use of body armor in police officers of the countryside specialized battalion of Ceará, Brazil

Move to health-a holistic approach to the management of chronic low back pain: an intervention and implementation protocol developed for a pragmatic clinical trial

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