Trial of Scrambler Therapy or Sham Treatment for Low Back Pain

June 9, 2017 updated by: Virginia Commonwealth University

A Pilot Randomized Trial of Scrambler Therapy or Sham Treatment for Persistent Nonspecific 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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Calmare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to 3 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Angela Starkweather, PhD, ACNP-BC, Virginia Commonwealth University School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (ESTIMATE)

July 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20002340
  • SCRA-LBP (OTHER: VCU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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