Spinal Cord Stimulation (SCS) Dosing Study

This study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by SCS.

Study Overview

• Status: Completed
• Conditions: Back Pain; Leg Pain
• Intervention / Treatment: Device: Spinal Cord Stimulation

Detailed Description

This feasibility study assessed the following outcomes:

• Patient satisfaction
• VAS pain scores

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Pain Doctors
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • Georgia Pain and Wellness Center
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Global Scientific Innovations
    • Indianapolis, Indiana, United States, 46202
      • Goodman Campbell Brain and Spine
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Kentuckiana Pain Specialists
    • Somerset, Kentucky, United States, 42503
      • Drez One, LLC
  • Missouri
    • Cape Girardeau, Missouri, United States, 63701
      • Regional Brain & Spine
  • Texas
    • Tyler, Texas, United States, 75701
      • Precision Spine Care
  • Washington
    • Spokane, Washington, United States, 99201
      • Northwest Pain Care, Inc.
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Spinal Cord Stimulation; Each subject was programmed to 4 different amplitude settings: 80%, 60%, 40% and 20% of perception threshold amplitude	Device: Spinal Cord Stimulation; Programming

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCS Therapy Satisfaction	To characterize the effect of four different amplitude settings on baseline SCS therapy satisfaction. At each follow-up visit, the following question was asked to measure satisfaction: "Overall how satisfied or unsatisfied are you with this therapy?". The response choices were as follows: "very satisfied", "somewhat satisfied", "neutral", "somewhat unsatisfied", "very unsatisfied". Each subject was considered to have maintained their baseline SCS therapy satisfaction if they selected the response "very satisfied", "somewhat satisfied", or "neutral", otherwise they were considered dissatisfied with the therapy. The first visit in which each subject reported dissatisfaction of the therapy was recorded. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained each subject's therapy satisfaction. The frequency and percentage of subjects' that maintained baseline satisfaction were reported at each amplitude level.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)	To characterize the effect of four different amplitude settings on baseline pain relief. During each follow-up period the VAS pain score was recorded once a day, on a multi-day diary, where subjects rated their pain by making a vertical slash mark through the 0-10 cm line that best described their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS pain score represented worse pain. The average VAS pain scores from the last 3 days of the diary prior to the scheduled visit was used for analysis. Each subject was considered to have maintained their baseline pain if there was less than a 2 point increase in their average pain score at the follow-up period. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained the subject's pain relief. The frequency and percentage of subjects' that maintained their average baseline VAS pain score were reported at each amplitude level.	8 weeks

Collaborators and Investigators

• Sponsor: MedtronicNeuro

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ACTUAL): March 15, 2019
• Study Completion (ACTUAL): March 15, 2019

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (ACTUAL): September 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: MDT17046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes