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Calmare Therapeutics Incorporated Message Board

  • favela808 favela808 Jul 15, 2013 11:40 AM Flag


    Trial of Scrambler Therapy or Sham Treatment for Low Back Pain
    This study is currently recruiting participants.
    Verified July 2013 by Virginia Commonwealth University
    Virginia Commonwealth University
    Information provided by (Responsible Party):
    Virginia Commonwealth University Identifier:
    First received: May 13, 2013
    Last updated: July 10, 2013
    Last verified: July 2013
    History of Changes
    Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
    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.

    Condition Intervention
    Low Back Pain
    Device: Scrambler

    Study Type: Interventional
    Study Design: Allocation: Randomized
    Endpoint Classification: Efficacy Study
    Intervention Model: Single Group 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

    Resource links provided by NLM:

    MedlinePlus related topics: Back Pain
    U.S. FDA Resources

    Further study details as provided by Virginia Commonwealth University:

    Primary Outcome Measures:
    change in low back pain [ Time Frame: baseline to 1 week post-treatment ] [ Designated as safety issue: No ]
    Low back pain will be measured by the brief pain inventory (BPI)

    Estimated Enrollment: 32
    Study Start Date: March 2013
    Estimated Study Completion Date: August 2013
    Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
    Arms Assigned Interventions
    Experimental: Scrambler therapy
    Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
    Device: Scrambler
    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 d

    Sentiment: Strong Buy

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