Spinal Cord Stimulation (SCS) Dosing Study

Medtronic

Status and phase: Completed; Phase 4

Conditions: Back Pain; Leg Pain

Treatments: Device: Spinal Cord Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03284411

MDT17046

Details and patient eligibility

About

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

Full description

This feasibility study assessed the following outcomes:

• Patient satisfaction
• VAS pain scores

Enrollment: 30 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Spinal Cord Stimulation

Experimental group

Description:

Each subject was programmed to 4 different amplitude settings: 80%, 60%, 40% and 20% of perception threshold amplitude

Treatment:

Device: Spinal Cord Stimulation