Trial of Scrambler Therapy or Sham Treatment for Low Back Pain

Not Applicable

Completed

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Scrambler therapy	Scrambler	Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
Sham Scrambler treatment	Scrambler	Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days

Primary Outcome Measures

Name	Time	Method
Worst Low Back Pain Score	baseline to 3 weeks post-treatment	Low back pain will be measured by the Brief Pain Inventory (BPI). The BPI assesses the severity of pain, location of pain, pain medications, amount of pain relief in the past 24 hours and the past week, and the impact of pain on daily functions. For this study, the worst pain score will be used in the analysis. The worst pain score is rated from "0" meaning no pain to "10" meaning pain as bad as you can imagine.

Secondary Outcome Measures