Trial of Scrambler Therapy or Sham Treatment for Low Back Pain
| Status: | Completed |
|---|---|
| Conditions: | Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 3/1/2014 |
| Start Date: | March 2013 |
| End Date: | August 2013 |
| Contact: | Angela Starkweather, PhD, ACNP-BC |
| Email: | astarkweathe@vcu.edu |
| Phone: | 8048283986 |
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.
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.
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 18-60 years of age
- diagnosed with persistent nonspecific LBP
- comprehend English
Exclusion Criteria:
- <18 or >60 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
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