Trial of Scrambler Therapy or Sham Treatment for 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Pilot Randomized Trial of Scrambler Therapy or Sham Treatment for Persistent Nonspecific Low Back Pain|
- Worst Low Back Pain Score [ Time Frame: baseline to 3 weeks post-treatment ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2013|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Scrambler therapy
Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
Other Name: Calmare
Sham Comparator: Sham Scrambler treatment
Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days
Other Name: Calmare
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01896687
|United States, Virginia|
|Virginia Commonwealth University School of Nursing|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Angela Starkweather, PhD, ACNP-BC||Virginia Commonwealth University School of Nursing|