Subacute Low Back Pain in Active Duty
Condition: Subacute Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Progressive Exercise Plan; NeuromuscularElectricalStimulation(NMES); Primary Care Management (PCM)
Intervention type(s): Behavioral; Device; Behavioral
Intervention description(s): The goal of PEP is to reduce back pain, disability, and improve trunk flexibility, strength and endurance through controlled, gradual, progressive back exercises. PEP teaches muscle strengthening exercises and self-management strategies to promote back fitness. PEP sessions provide a standardized self-management framework for performing the exercises at home. PEP is performed every other day/week for about ~1 hour over a period of 9 weeks. PEP consists of 3 sequential phases with each phase lasting 3 weeks. Exercises become progressively more difficult and intense, focusing on back stretching and strengthening that progressively load and unload the lumbar spine by means of flexion/extension exercises. The PEP group will perform 31 exercise sessions for 60 minutes on alternating days.; The NMES treatment group will receive a portable battery-operated device, Recovery Back (Neurotech®, Minnetonka, MN) with a 2-garment site-specific system: back & abdomen. NMES muscle contractions will be elicited by an electrical impulse generated by the Recovery Back system. The device delivers a pre-set program of NMES using a symmetrical biphasic square pulse waveform. (Moore SR, Shurman J, 1997) The garments are light-weight, breathable fabric that wraps around the waist with precise placements for the reusable electrodes. The controller uses a rechargeable battery with charger supplied. The NMES protocol consists of 30-minutes of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back training, next day Abdominal training).; All participants will receive standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase their activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants will receive an information sheet on LBP advising them to remain active and use self-care options such as heat application. To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment