Trial of Scrambler Therapy or Sham Treatment for Low Back Pain - Full Text View

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: Parallel 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:

Worst Low Back Pain Score [ Time Frame: baseline to 3 weeks post-treatment ] [ Designated as safety issue: No ]
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.


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 50 Years (Adult)
Genders Eligible for Study:	Both
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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Starkweather AR, Coyne P, Lyon DE, Elswick RK Jr, An K, Sturgill J. Decreased low back pain intensity and differential gene expression following Calmare®: 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.


Responsible Party:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT01896687 History of Changes
Other Study ID Numbers:	SCRA-LBP
Study First Received:	May 13, 2013
Results First Received:	August 18, 2014
Last Updated:	July 19, 2016
Health Authority:	United States: Institutional Review Board
Individual Participant Data
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

ClinicalTrials.gov processed this record on September 30, 2016