Trial of Scrambler Therapy or Sham Treatment for Low Back Pain

Low Back Pain Clinical Trial

Official title:

A Pilot Randomized Trial of Scrambler Therapy or Sham Treatment for Persistent Nonspecific Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896687
• Other study ID #: HM20002340
• Secondary ID: SCRA-LBP
• Status: Completed
• Phase: N/A
• First received: May 13, 2013
• Last updated: June 9, 2017
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: June 2017
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Scrambler
Electrotherapy

Locations

Country	Name	City	State
United States	Virginia Commonwealth University School of Nursing	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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