Trial of Scrambler Therapy or Sham Treatment for Low Back Pain
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ClinicalTrials.gov Identifier: NCT01896687 |
Recruitment Status :
Completed
First Posted : July 11, 2013
Results First Posted : September 15, 2014
Last Update Posted : June 14, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Low Back Pain | Device: Scrambler | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Randomized Trial of Scrambler Therapy or Sham Treatment for Persistent Nonspecific Low Back Pain |
Study Start Date : | March 2013 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Scrambler therapy
Scrambler therapy applied to region of low back pain for 30 minutes x 10 days
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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 |
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896687
United States, Virginia | |
Virginia Commonwealth University School of Nursing | |
Richmond, Virginia, United States, 23298 |
Principal Investigator: | Angela Starkweather, PhD, ACNP-BC | Virginia Commonwealth University School of Nursing |
Responsible Party: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT01896687 |
Other Study ID Numbers: |
HM20002340 SCRA-LBP ( Other Identifier: VCU ) |
First Posted: | July 11, 2013 Key Record Dates |
Results First Posted: | September 15, 2014 |
Last Update Posted: | June 14, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
nonspecific low back pain chronic low back pain |
Back Pain Low Back Pain Pain Neurologic Manifestations |