Trial of Scrambler Therapy or Sham Treatment for Low Back Pain

A Pilot Randomized Trial of Scrambler Therapy or Sham Treatment for Persistent Nonspecific Low Back Pain

This pilot study will evaluate Scrambler therapy and Sham treatment on levels of low back pain, pain sensitivity and mRNA expression of pain sensitivity candidate genes.

This pilot study will evaluate the feasibility of the experimental protocol and provide sufficient pilot data to estimate statistical power and sample size requirements. The study will include 30 individuals (15 per group) diagnosed with persistent low back pain who will receive a standard protocol of Scrambler therapy or sham treatment. Participant data will include subjective measures of low back pain, pain sensitivity using quantitative sensory testing, and mRNA expression levels of pain sensitivity candidate genes at baseline (prior to treatment) and 1 and 3 weeks post-treatment.

Inclusion Criteria:

• be 18-50 years of age
• diagnosed with persistent nonspecific LBP
• comprehend English

Exclusion Criteria:

• <18 or >50 years of age
• chronic pain at another site or associated with a painful condition
• pregnant or within 3 months post-partum
• implanted drug delivery system
• heart stents or metal implants such as pacemakers, automatic defibrillator, aneurysm clips, vena cave slips, or skull plates
• history of myocardial infarction or ischemic heart disease within the past six months
• history of epilepsy
• skin conditions such as open sores that would prevent proper application of electrodes