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Trial of Scrambler Therapy or Sham Treatment for Low Back Pain
This study has been completed.
Sponsor:
Virginia Commonwealth University
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01896687
First received: May 13, 2013
Last updated: June 9, 2017
Last verified: June 2017
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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 Intervention Model: Parallel Assignment Masking: Participant, 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:
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 ]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) |
| Sexes Eligible for Study: | All |
| 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
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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
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
National Institute of Nursing Research (NINR)
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):
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT01896687 History of Changes |
| Other Study ID Numbers: |
HM20002340 SCRA-LBP ( Other Identifier: VCU ) |
| Study First Received: | May 13, 2013 |
| Results First Received: | August 18, 2014 |
| Last Updated: | June 9, 2017 |
| 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 June 23, 2017