Trial of Scrambler Therapy or Sham Treatment for Low Back Pain

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Low Back Pain

Treatments

Device: Scrambler

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01896687

HM20002340

SCRA-LBP (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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