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A SMART design to determine the optimal treatment of chronic pain among military personnel.

ABSTRACT: Chronic pain is a leading cause of disability among active duty service members in the U.S. armed forces. Standard rehabilitative care and complementary and integrative health therapies are used for chronic pain rehabilitation. However, the optimal sequence and duration of these therapies has yet to be determined. This article describes a sequential multiple assignment randomized trial (SMART) protocol being used to identify the optimal components and sequence of standard rehabilitative care and complementary and integrative health therapies for reducing pain impact and improving other patient outcomes. Active duty service members referred to Madigan Army Medical Center for treatment of chronic pain are being recruited to the Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies study. Study participants are randomized to either standard rehabilitative care (physical and occupational therapy and psychoeducation) or complementary and integrative health therapies (chiropractic, acupuncture, yoga and psychoeducation). Those participants who do not respond to the first 3?weeks of treatment are randomized to receive an additional 3?weeks of either (1) the alternative treatment or (2) the first-stage treatment plus the alternative treatment. This study will also determine factors associated with treatment response that can support clinical decision making, such as baseline fitness, pain catastrophizing, kinesiophobia, post-traumatic stress, pain self-efficacy, and biological indicators. The information gained from this research will be applicable to all integrative chronic pain rehabilitation programs throughout the U.S. Department of Defense and the U.S. Department of Veterans Affairs, and the broader rehabilitation community.

SUBMITTER: Flynn D

PROVIDER: S-EPMC6234001 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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A SMART design to determine the optimal treatment of chronic pain among military personnel.

Flynn Diane D Eaton Linda H LH Langford Dale J DJ Ieronimakis Nicholas N McQuinn Honor H Burney Richard O RO Holmes Samuel L SL Doorenbos Ardith Z AZ

Contemporary clinical trials 20180824

Chronic pain is a leading cause of disability among active duty service members in the U.S. armed forces. Standard rehabilitative care and complementary and integrative health therapies are used for chronic pain rehabilitation. However, the optimal sequence and duration of these therapies has yet to be determined. This article describes a sequential multiple assignment randomized trial (SMART) protocol being used to identify the optimal components and sequence of standard rehabilitative care and ...[more]

PMID: 30145267

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Project description:Low back pain is highly prevalent and one of the most common causes of disability in U.S. armed forces personnel. Currently, no single therapeutic method has been established as a gold standard treatment for this increasingly prevalent condition. One commonly used treatment, which has demonstrated consistent positive outcomes in terms of pain and function within a civilian population is spinal manipulative therapy provided by doctors of chiropractic. Chiropractic care, delivered within a multidisciplinary framework in military healthcare settings, has the potential to help improve clinical outcomes for military personnel with low back pain. However, its effectiveness in a military setting has not been well established. The primary objective of this study is to evaluate changes in pain and disability in active duty service members with low back pain who are allocated to receive usual medical care plus chiropractic care versus treatment with usual medical care alone.This pragmatic comparative effectiveness trial will enroll 750 active duty service members with low back pain at three military treatment facilities within the United States (250 from each site) who will be allocated to receive usual medical care plus chiropractic care or usual medical care alone for 6 weeks. Primary outcomes will include the numerical rating scale for pain intensity and the Roland-Morris Disability Questionnaire at week 6. Patient reported outcomes of pain, disability, bothersomeness, and back pain function will be collected at 2, 4, 6, and 12 weeks from allocation.Because low back pain is one of the leading causes of disability among U.S. military personnel, it is important to find pragmatic and conservative treatments that will treat low back pain and preserve low back function so that military readiness is maintained. Thus, it is important to evaluate the effects of the addition of chiropractic care to usual medical care on low back pain and disability.The trial discussed in this article was registered in ClinicalTrials.gov with the NCT01692275 Date of registration: 6 September 2012.

Project description:Low back pain (LBP) is a major cause of visits to ambulatory care, missed duty time, and disability discharge. The subacute phase of LBP presents an opportune time to prevent chronicity and lessen recurrence. The goal of this randomized controlled trial (RCT) was to determine the relative effectiveness of neuromuscular electrical stimulation (NMES) training and a progressive exercise program (PEP) on improving physical performance, pain, and torso strength in U.S. service members with subacute LBP, compared to standard primary care management (PCM) alone. This is an Institutional Review Board-approved protocol for an RCT conducted with active duty military personnel (n = 128) at Fort Campbell, Kentucky, between April 2018 and March 2020. Participants were randomized to receive NMES (n = 43), PEP (n = 42), or PCM (n = 43) for 9 weeks. Outcome measures of physical performance (sit-ups, push-ups, walking, and torso endurance), torso muscle strength (flexion and extension), and pain were assessed at baseline and after 3, 6, and 9 weeks. Analysis was intent-to-treat using linear mixed effects models. A sensitivity analysis was performed to address the protocol deviations that occurred in response to coronavirus disease 2019 pandemic, which required rescheduling 17 in-person study visits to home assessments at 9-week testing. Evidence was found for group differences in physical performance for sit-ups and push-ups, with NMES showing greater improvement than PCM. The two groups showed similar improvements in torso muscle strength, although the NMES groups may show better improvement during early treatment. No group differences in pain levels were observed during the intervention, and all groups improved during the course of the study period. The amount of NMES muscle stimulation was directly related to the level of improvement, which was not the case for the hours reported for PEP exercise. In an active duty population with subacute LBP, integrating NMES strength training into the rehabilitation therapy may offer a modest benefit for increasing sit-ups and push-ups and improving torso strength.

Project description:Background: Leishmaniasis is one of the most important infectious diseases affecting the Colombian National Army due to the high number of reported cases and exposure throughout military operations in endemic areas. The main aim of this study was to estimate the geographical distribution along with the genetic diversity and treatment outcome of Leishmania species in Colombian military personnel.Methods: Skin lesion samples by smear and aspirate were collected in 136 patients having parasitological cutaneous leishmaniasis (CL) diagnosis. DNA was extracted, the nuclear marker heat shock protein 70 (HSP70) was amplified by PCR and sequenced. Leishmania species were identified by BLASTn. The geo-spatial distribution of the identified parasites was determined according to the possible site of infection. Gene tree was constructed by maximum likelihood (ML), diversity indices (?, h) were estimated and haplotype network was constructed under the Templeton-Crandall-Sing algorithm in order to determine the geographic relationships of the genetic variants of Leishmania species circulating in Colombian military population.Results: The species were identified in 77.94% of the samples, with a predominance of L. braziliensis (65.09%), followed by L. panamensis (31.13%), L. naiffi by the first time reported in Colombia in two patients (1.89%) as well as L. lindenbergi in a single patient (0.945%) with possible infection in the municipality of Miraflores, Guaviare and L. infantum in a single patient (0.945%) notified with CL in the municipality of Tumaco, Nariño. The phylogenetic analysis was consistent according to bootstrap, showing four strongly differentiated clades.Conclusions: The geo-spatial distribution suggested that L. braziliensis has a greater abundance, while L. panamensis has a greater dispersion. The phylogenetic relationships of Leishmania species in Colombian military personnel was estimated with the confirmation of two new species circulating without prior report in the country and a species with no background for CL in the Colombian army. A substantial genetic diversity of Leishmania braziliensis was defined. This study contributes through the understanding of the molecular epidemiology to the CL transmission in Colombia.

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A SMART design to determine the optimal treatment of chronic pain among military personnel.

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A SMART design to determine the optimal treatment of chronic pain among military personnel.

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