Subacute Low Back Pain Clinical Trial
Official title:
Home-based Approaches for Subacute Low Back Pain in Active Duty: Randomized, Controlled Trial
The overall objective of this project is to compare three home-managed treatment regimens for subacute low back pain: Progressive Exercise Plan (PEP), NMES (neuromuscular electrical stimulation) core strength training and standard primary care management (PCM). Each of the two treatment arms will be supplemented by Primary Care Management. The specific aim of the study is to determine whether the two treatment regimes are significantly more efficacious than standard PCM alone in improving lower back muscle strength, daily physical activity, physical function, quality of life, and symptoms associated with subacute LBP.
The overall objective of this project is to compare three home-managed treatment regimens for subacute low back pain: Progressive Exercise Plan (PEP), NMES (neuromuscular electrical stimulation) core strength training and standard primary care management (PCM). The central hypothesis is that the NMES with PCM core strength training and PEP with PCM will show significantly greater improvements in muscle strength, pain, mobility/function, daily activity and quality of life (QOL) than PCM alone in military members with low back pain lasting three to eighteen weeks. The rationale for this study is that increasing torso muscle strength and decreasing pain through strength training exercises will significantly improve mobility, physical activity, QOL and reduce disability. Such outcomes could ultimately result in improved deployability, retention of military personnel and decreased economic costs in this population. The specific aims will be to determine whether the two treatment régimes are significantly more efficacious than standard PCM alone in improving lower back muscle strength, daily physical activity, physical function, quality of life, and symptoms associated with subacute LBP. After consent and baseline testing, active duty male and female subjects, ages 18 to <45, (n=135) with LBP will be randomly assigned to one of the three groups. Each of the two treatment arms will be supplemented by PCM and compared to a group receiving standard PCM alone. All groups will receive nine weeks of home therapy. Using longitudinal mixed regression models, differences in time trends for the outcome variables among controls and those in the treatment groups will be examined. In these regression analyses, the important primary measures will be expressed as a function of time, treatment group, and group-by-time interactions, while controlling for important covariates. Positive results could translate into accelerated rehabilitation, decreased symptoms and lower medical costs with better patient outcomes. ;
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