Decreased low back pain intensity and differential gene expression following Calmare®: results from a double-blinded randomized sham-controlled study

Res Nurs Health. 2015 Feb;38(1):29-38. doi: 10.1002/nur.21632. Epub 2015 Jan 8.


In this double-blinded, randomized controlled trial we evaluated the effects of Calmare®, a non-invasive neurocutaneous electrical pain intervention, on lower back pain intensity as measured by the "worst" pain score and on pain interference using the Brief Pain Inventory-Short Form, on measures of pain sensitivity assessed by quantitative sensory testing, and on mRNA expression of pain sensitivity genes. Thirty participants were randomized to receive up to 10 sessions of Calmare® treatment (n = 15) or a sham treatment (n = 15) using the same device at a non-therapeutic threshold. At 3 weeks after conclusion of treatment, compared with the sham group, the Calmare® group reported a significant decrease in the "worst" pain and interference scores. There were also significant differences in pain sensitivity and differential mRNA expression of 17 pain genes, suggesting that Calmare® can be effective in reducing pain intensity and interference in individuals with persistent low back pain by altering the mechanisms of enhanced pain sensitivity. Further study of long-term pain outcomes, particularly functional status, analgesic use and health care utilization, is warranted.

Trial registration: NCT01896687.

Keywords: Calmare®; chronic pain; gene expression; low back pain; scrambler.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Adult
  • Chronic Pain / genetics*
  • Chronic Pain / physiopathology
  • Chronic Pain / therapy*
  • Double-Blind Method
  • Female
  • Gene Expression*
  • Humans
  • Low Back Pain / genetics*
  • Low Back Pain / physiopathology
  • Low Back Pain / therapy*
  • Male
  • Middle Aged
  • Pain Management
  • Pain Measurement
  • Pain Threshold
  • Severity of Illness Index
  • Transcutaneous Electric Nerve Stimulation / instrumentation*
  • Treatment Outcome

Associated data