title: Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial.
abstract: BACKGROUND
  Non-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave(®) Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chronic non-specific low back pain patients.
  
  
  METHODS
  
  
  
  METHODS
  Chronic non-specific low back pain patients between ages of 18-65 years, with pain of at least 3 months duration and minimal current 5/10 VAS pain. Patients will have no significant signs or symptoms of lumbosacral nerve impingement, malignancy, spinal stenosis, or mood disorders.
  
  
  METHODS
  Double blind RCT with 3 arms and 38 subjects per arm. Randomization by permuted blocks of random length, stratified by Workers Compensation claim (yes vs. no), and use of opioids. The null hypothesis of this study is that there are no statistically significant differences in functional improvement between treatment types during and at the end of a 12-week week treatment period.
  
  
  METHODS
  Subjective data will be collected using Filemaker Pro™ database management collection tools. Objective data will be obtained through functional assessments. Data will be collected at enrollment and at 1, 4, 8, and 12 weeks for each participant by a blinded assessor.
  
  
  METHODS
  H-Wave(®) device stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical numbers of visits (4) and researcher contact time (approximately 15 hours).
  
  
  RESULTS
  
  
  
  METHODS
  Oswestry Disability Index. Secondary measures include: Rowland Morris Instrument, VAS pain score, functional evaluation including strength when pushing and pulling, pain free range of motion in flexion and extension. Outcome measures assessed at baseline, 1, 4, 8, and 12 weeks. Treatment failure will be defined if patient terminates assigned treatment arm for non-efficacy or undergoes invasive procedure or other excluded cointerventions. Data will be analyzed using intention-to-treat analysis and adjusted for covariates related to LBP (e.g. age) as needed.
  
  
  CONCLUSIONS
  Study strengths include complex randomization, treatment group allocation concealment, double blinding, controlling for co-interventions, rigorous inclusion criteria, assessment of compliance, plans for limiting dropout, identical assessment methods and timing for each treatment arm, and planned intention-to-treat analyses.
authors.affiliation: Rocky Mountain Center for Occupational & Environment Health, Department of Family and Preventive Medicine, University of Utah, 391 Chipeta Way, Suite C, Salt Lake City, UT 84108, USA. matt.thiese@hsc.utah.edu
authors.forename: Matthew S
authors.initials: MS
authors.lastname: Thiese
authors.forename: Matthew
authors.initials: M
authors.lastname: Hughes
authors.forename: Jeremy
authors.initials: J
authors.lastname: Biggs
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D059350:Chronic Pain / Q000175:diagnosis / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000379:methods*; D004561:Transcutaneous Electric Nerve Stimulation / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
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