Spinal Cord Stimulation (SCS) Dosing Study

• Sponsor: MedtronicNeuro (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03284411
• Collaborator: (none)
• Enrollment: 30
• Locations: 10
• Arm: 1
• Actual Duration (Months): 16.4
• Patients Per Site: 3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Back Pain; Leg Pain	Device: Spinal Cord Stimulation	Phase 4

Detailed Description

This feasibility study assessed the following outcomes:

• Patient satisfaction

• VAS pain scores

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Spinal Cord Stimulation (SCS) Dosing Study
• Actual Study Start Date: Nov 1, 2017
• Actual Primary Completion Date: Mar 15, 2019
• Actual Study Completion Date: Mar 15, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Pain Doctors	Chandler	Arizona	United States	85224
2	Georgia Pain and Wellness Center	Lawrenceville	Georgia	United States	30046
3	Global Scientific Innovations	Evansville	Indiana	United States	47714
4	Goodman Campbell Brain and Spine	Indianapolis	Indiana	United States	46202
5	Kentuckiana Pain Specialists	Louisville	Kentucky	United States	40241
6	Drez One, LLC	Somerset	Kentucky	United States	42503
7	Regional Brain & Spine	Cape Girardeau	Missouri	United States	63701
8	Precision Spine Care	Tyler	Texas	United States	75701
9	Northwest Pain Care, Inc.	Spokane	Washington	United States	99201
10	University of Wisconsin	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• MedtronicNeuro

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Aug 22, 2017
• Statistical Analysis Plan - Dec 14, 2017

More Information

Publications

None provided.

• Responsible Party: MedtronicNeuro
• ClinicalTrials.gov Identifier: NCT03284411
• Other Study ID Numbers: MDT17046
• First Posted: Sep 15, 2017
• Last Update Posted: Apr 15, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Back Pain

Study Results

Participant Flow

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of their perception threshold amplitude). Spinal Cord Stimulation: Programming
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of their perception threshold). Spinal Cord Stimulation: Programming
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.1 (11.9)
Sex: Female, Male (Count of Participants)
Female	23 76.7%
Male	7 23.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	30 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	SCS Therapy Satisfaction
Description	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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of perception threshold). Spinal Cord Stimulation: Programming
Measure Participants	30
Baseline	6 20%
80% perception threshold	2 6.7%
60% perception threshold	1 3.3%
40% perception threshold	0 0%
20% perception threshold	21 70%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Each subject was programmed to 4 different amplitude settings (80, 60, 40, 20 percent of perception threshold). Spinal Cord Stimulation: Programming
Measure Participants	30
Baseline	5 16.7%
80% perception threshold	3 10%
60% perception threshold	1 3.3%
40% perception threshold	2 6.7%
20% perception threshold	19 63.3%

Adverse Events

Time Frame	Adverse events were collected from enrollment to study discontinuation with an average of 2.2 months
Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Each subject was programmed to 4 different amplitude settings (80, 60, 40, and 20 percent of their perception threshold) Spinal Cord Stimulation: Programming
All Cause Mortality
	Spinal Cord Stimulation
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	Spinal Cord Stimulation
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Spinal Cord Stimulation
	Affected / at Risk (%)	# Events
Total	5/30 (16.7%)
General disorders
Inadequate analgesia	1/30 (3.3%)	1
Musculoskeletal and connective tissue disorders
Back pain	1/30 (3.3%)	1
Product Issues
Device stimulation issue	3/30 (10%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.