Spinal Cord Stimulation (SCS) Dosing Study

Phase 4

Completed

• Conditions: Back Pain; Leg Pain
• Interventions: Device: Spinal Cord Stimulation

• Registration Number: NCT03284411
• Lead Sponsor: MedtronicNeuro

Brief Summary

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

Detailed Description

This feasibility study assessed the following outcomes:

* Patient satisfaction

* VAS pain scores

Study Timeline

• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-15
• Study Start: 2017-11-01
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Results First Submitted: 2020-03-03
• Results First Submitted QC: 2020-03-03
• Results First Posted: 2020-03-18
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulation	Spinal Cord Stimulation	Each subject was programmed to 4 different amplitude settings: 80%, 60%, 40% and 20% of perception threshold amplitude

Primary Outcome Measures

Name	Time	Method
SCS Therapy Satisfaction	8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)	8 weeks	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.

Trial Locations

Locations (10)

Goodman Campbell Brain and Spine; 🇺🇸 Indianapolis, Indiana, United States

Drez One, LLC; 🇺🇸 Somerset, Kentucky, United States

Kentuckiana Pain Specialists; 🇺🇸 Louisville, Kentucky, United States

Georgia Pain and Wellness Center; 🇺🇸 Lawrenceville, Georgia, United States

Arizona Pain Doctors; 🇺🇸 Chandler, Arizona, United States

Global Scientific Innovations; 🇺🇸 Evansville, Indiana, United States

Regional Brain & Spine; 🇺🇸 Cape Girardeau, Missouri, United States

Precision Spine Care; 🇺🇸 Tyler, Texas, United States

Northwest Pain Care, Inc.; 🇺🇸 Spokane, Washington, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States