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Trial of Scrambler Therapy or Sham Treatment for Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scrambler
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring nonspecific low back pain, chronic low back pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Scrambler therapy

Sham Scrambler treatment

Arm Description

Scrambler therapy applied to region of low back pain for 30 minutes x 10 days

Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days

Outcomes

Primary Outcome Measures

Worst Low Back Pain Score
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.

Secondary Outcome Measures

Full Information

First Posted
May 13, 2013
Last Updated
June 9, 2017
Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01896687
Brief Title
Trial of Scrambler Therapy or Sham Treatment for Low Back Pain
Official Title
A Pilot Randomized Trial of Scrambler Therapy or Sham Treatment for Persistent Nonspecific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
nonspecific low back pain, chronic low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scrambler therapy
Arm Type
Experimental
Arm Description
Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
Arm Title
Sham Scrambler treatment
Arm Type
Sham Comparator
Arm Description
Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days
Intervention Type
Device
Intervention Name(s)
Scrambler
Other Intervention Name(s)
Calmare
Intervention Description
Electrotherapy
Primary Outcome Measure Information:
Title
Worst Low Back Pain Score
Description
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.
Time Frame
baseline to 3 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Starkweather, PhD, ACNP-BC
Organizational Affiliation
Virginia Commonwealth University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University School of Nursing
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25572279
Citation
Starkweather AR, Coyne P, Lyon DE, Elswick RK Jr, An K, Sturgill J. Decreased low back pain intensity and differential gene expression following Calmare(R): results from a double-blinded randomized sham-controlled study. Res Nurs Health. 2015 Feb;38(1):29-38. doi: 10.1002/nur.21632. Epub 2015 Jan 8.
Results Reference
derived

Learn more about this trial

Trial of Scrambler Therapy or Sham Treatment for Low Back Pain

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