Trial of Scrambler Therapy or Sham Treatment for Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01896687
First received: May 13, 2013
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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:


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)


Enrollment: 30
Study Start Date: March 2013
Study Completion Date: August 2013
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896687

Locations
United States, Virginia
Virginia Commonwealth University School of Nursing
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Angela Starkweather, PhD, ACNP-BC Virginia Commonwealth University School of Nursing
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01896687     History of Changes
Other Study ID Numbers: SCRA-LBP
Study First Received: May 13, 2013
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014