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Transcutaneous Electrical Nerve Stimulation Device
1 for Lower Back Pain (E-STIM Trial)
N/A
Waitlist Available
Research Sponsored by Empi, A DJO Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be 18-65 years of age.
Subjects must report a low back pain score of 4 or greater on the 0-10 point Numerical Rating Scale (NRS) for average daily pain.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 4, 8 and 12 week follow-up
Awards & highlights
E-STIM Trial Summary
This trial will test if a special device can reduce chronic lower back pain.
Eligible Conditions
- Lower Back Pain
E-STIM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowE-STIM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 4, 8 and 12 week follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 4, 8 and 12 week follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relief of lower back pain as measured by a Numerical Rating Scale (NRS) of Average Daily Pain.
Secondary outcome measures
Adverse Event Assessment: assess the occurrence and severity of any adverse events.
Improvement of function as measured by the Roland and Morris Back Pain Disability Scale.
Improvement of quality of life as measured by the SF-12 Health Survey.
+1 moreE-STIM Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: 1Active Control1 Intervention
Subjects in this study arm will receive treatment (fully active) Empi Select TENS devices.
Group II: 2Placebo Group1 Intervention
Subjects in this study arm will receive control (not fully active) Empi Select TENS devices.
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Who is running the clinical trial?
Empi, A DJO CompanyLead Sponsor
2 Previous Clinical Trials
206 Total Patients Enrolled
AlquestIndustry Sponsor
2 Previous Clinical Trials
1,728 Total Patients Enrolled
Jim Pomonis, PhDStudy DirectorEmpi, A DJO Company
Frequently Asked Questions
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