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Trial of Scrambler Therapy or Sham Treatment for Low Back Pain

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ClinicalTrials.gov Identifier: NCT01896687
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : September 15, 2014
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: Scrambler Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Randomized Trial of Scrambler Therapy or Sham Treatment for Persistent Nonspecific Low Back Pain
Study Start Date : March 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Scrambler therapy
Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
 Device: Scrambler
Electrotherapy
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
 Device: Scrambler
Electrotherapy
Other Name: Calmare


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896687


Locations
United States, Virginia
Virginia Commonwealth University School of Nursing
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Angela Starkweather, PhD, ACNP-BC Virginia Commonwealth University School of Nursing
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01896687     History of Changes
Other Study ID Numbers: HM20002340
SCRA-LBP ( Other Identifier: VCU )
First Posted: July 11, 2013    Key Record Dates
Results First Posted: September 15, 2014
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Virginia Commonwealth University:
nonspecific low back pain
chronic low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms