Spinal Cord Stimulation (SCS) Dosing Study

Back Pain Clinical Trial

Official title:

Spinal Cord Stimulation (SCS) Dosing Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284411
• Other study ID #: MDT17046
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2017
• Est. completion date: March 15, 2019

Study information

• Verified date: April 2020
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This feasibility study assessed the following outcomes:

• Patient satisfaction

• VAS pain scores

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Leg Pain

Intervention

Device:
• Spinal Cord Stimulation
Programming

Locations

Country	Name	City	State
United States	Regional Brain & Spine	Cape Girardeau	Missouri
United States	Arizona Pain Doctors	Chandler	Arizona
United States	Global Scientific Innovations	Evansville	Indiana
United States	Goodman Campbell Brain and Spine	Indianapolis	Indiana
United States	Georgia Pain and Wellness Center	Lawrenceville	Georgia
United States	Kentuckiana Pain Specialists	Louisville	Kentucky
United States	University of Wisconsin	Madison	Wisconsin
United States	Drez One, LLC	Somerset	Kentucky
United States	Northwest Pain Care, Inc.	Spokane	Washington
United States	Precision Spine Care	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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