NCT01896687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 15, 2014

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

May 13, 2013

Results QC Date

August 18, 2014

Last Update Submit

June 9, 2017

Conditions

Low Back Pain

Keywords

nonspecific low back painchronic low back pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline to 3 weeks post-treatment

Study Arms (2)

Scrambler therapy

EXPERIMENTAL

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

Device: Scrambler

Sham Scrambler treatment

SHAM COMPARATOR

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

Device: Scrambler

Interventions

ScramblerDEVICE

Electrotherapy

Also known as: Calmare
Scrambler therapySham Scrambler treatment

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • be 18-50 years of age
  • diagnosed with persistent nonspecific LBP
  • comprehend English

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University School of Nursing

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • 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.

    PMID: 25572279DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Angela Starkweather
Organization
Virginia Commonwealth University
astarkweathe@vcu.edu
8048283986

Study Officials

  • Angela Starkweather, PhD, ACNP-BC

    Virginia Commonwealth University School of Nursing

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2013

First Posted

July 11, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

June 14, 2017

Results First Posted

September 15, 2014

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)