Trial of Scrambler Therapy or Sham Treatment for Low Back Pain

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Scrambler therapy

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

Group Type EXPERIMENTAL

Scrambler

Intervention Type DEVICE

Electrotherapy

Sham Scrambler treatment

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

Group Type SHAM_COMPARATOR

Scrambler

Intervention Type DEVICE

Electrotherapy

Interventions

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Scrambler

Electrotherapy

Intervention Type DEVICE

Other Intervention Names

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Calmare

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No