Spinal Cord Stimulation (SCS) Dosing Study
Status: | Active, not recruiting |
---|---|
Conditions: | Back Pain, Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 22 - Any |
Updated: | 2/21/2019 |
Start Date: | November 1, 2017 |
End Date: | April 2019 |
This study will characterizes the effects of amplitude on subject satisfaction and pain
relief in subjects being treated by SCS.
relief in subjects being treated by SCS.
This feasibility study will assess the following outcomes:
- VAS pain scores
- Patient satisfaction
- VAS pain scores
- Patient satisfaction
Inclusion Criteria:
1. 22 years of age or older
2. Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month
3. Has approproate SCS settings
4. Willing and able to provide signed and dated informed consent
5. Capable of comprehending and consenting in English
6. Capable of getting into the supine and sitting positions
7. Willing and able to comply with all study procedures and visits
8. On stable (no change in dose, route, or frequency) prescribed pain medications
Exclusion Criteria:
1. Implanted with leads for peripheral nerve stimulation or an implantable intrathecal
drug delivery system
2. Had a pain-related surgery in the previous 1 month of enrollment or the intent to
undergo surgery during the period of the study
3. Implanted with quadripolar lead
4. Currently enrolled or planning to enroll in a potentially confounding clinical study
during the course of the study
5. Pregnant or is of child-bearing potential and unwilling to use a medically acceptable
form of birth control during the study
6. Has untreated major psychiatric comorbidity
7. Has serious drug-related behavioral issues
8. Has unresolved major issues of secondary gain
We found this trial at
10
sites
Indianapolis, Indiana 46202
Principal Investigator: Todd Schmidt, M.D.
Phone: 317-396-1254
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Cape Girardeau, Missouri 63701
Principal Investigator: Christopher Reis, D.O.
Phone: 573-332-7746
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725 South Dobson Road
Chandler, Arizona 85224
Chandler, Arizona 85224
Principal Investigator: Tristan Pico, M.D.
Phone: 602-795-8700
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Evansville, Indiana 47714
Principal Investigator: Mahendra Sanapati, M.D.
Phone: 812-437-7711
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Lawrenceville, Georgia 30046
Principal Investigator: Amit Patel, M.D.
Phone: 770-962-3642
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Louisville, Kentucky 40241
Principal Investigator: Ajith Nair
Phone: 502-995-4004
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Alaa Abd-Elsayed, M.D., M.P.H
Phone: 608-263-2704
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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75 Hail Knob Road
Somerset, Kentucky 42503
Somerset, Kentucky 42503
Principal Investigator: Amr O El-Naggar, M.D.
Phone: 606-263-2912
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Spokane, Washington 99201
Principal Investigator: John Hatheway, M.D.
Phone: 509-863-9789
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Tyler, Texas 75701
Principal Investigator: Aaron Calodney, M.D.
Phone: 903-531-0566
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