Trial of Scrambler Therapy or Sham Treatment for Low Back Pain

Overview

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 Title of Study: “A Pilot Randomized Trial of Scrambler Therapy or Sham Treatment for Persistent Nonspecific Low Back Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2013

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.

Interventions

  • Device: Scrambler
    • Electrotherapy

Arms, Groups and Cohorts

  • Experimental: Scrambler therapy
    • Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
  • Sham Comparator: Sham Scrambler treatment
    • Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days

Clinical Trial Outcome Measures

Primary Measures

  • Worst Low Back Pain Score
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Virginia Commonwealth University
  • Collaborator
    • National Institute of Nursing Research (NINR)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Angela Starkweather, PhD, ACNP-BC, Principal Investigator, Virginia Commonwealth University School of Nursing

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