Trial of Scrambler Therapy or Sham Treatment for Low Back Pain

Study Overview
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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.

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.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Scrambler


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scrambler therapy<br>Scrambler therapy applied to region of low back pain for 30 minutes x 10 days | Device: Scrambler<br>* Electrotherapy<br>* Other names: Calmare;|
| Sham Comparator: Sham Scrambler treatment<br>Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days | Device: Scrambler<br>* Electrotherapy<br>* Other names: Calmare;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nonspecific low back pain, chronic low back pain