title: Decreased low back pain intensity and differential gene expression following Calmare®: results from a double-blinded randomized sham-controlled study.
abstract: 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.
authors.affiliation: Associate Professor and Chair Department of Adult Health and Nursing Systems, Virginia Commonwealth University School of Nursing, 1100 East Leigh Street, P.O. Box 980567, Richmond, VA 23298-0567.
authors.forename: Angela R
authors.initials: AR
authors.lastname: Starkweather
authors.forename: Patrick
authors.initials: P
authors.lastname: Coyne
authors.forename: Debra E
authors.initials: DE
authors.lastname: Lyon
authors.forename: R K
authors.initials: RK
authors.lastname: Elswick
authors.forename: Kyungeh
authors.initials: K
authors.lastname: An
authors.forename: Jamie
authors.initials: J
authors.lastname: Sturgill
mesh_terms: D000293:Adolescent; D000328:Adult; D059350:Chronic Pain / Q000235:genetics* / Q000503:physiopathology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D015870:Gene Expression; D006801:Humans; D017116:Low Back Pain / Q000235:genetics* / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D059408:Pain Management; D010147:Pain Measurement; D017288:Pain Threshold; D012720:Severity of Illness Index; D004561:Transcutaneous Electric Nerve Stimulation / Q000295:instrumentation*; D016896:Treatment Outcome
keywords: Calmare®; chronic pain; gene expression; low back pain; scrambler