Spinal Cord Stimulation (SCS) Dosing Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Spinal Cord Stimulation (SCS) Therapy Study

NCT02371122

Failed Back Surgery Syndrome Degenerative Disk Disease Epidural Fibrosis +2 more

WITHDRAWN NA

Spinal Cord Stimulation Research Study

NCT00768872

Chronic Low Back and Leg Pain

COMPLETED

Spinal Cord Stimulation Efficacy Measures

NCT00351208

Chronic Pain in the Trunk and Limbs

UNKNOWN PHASE1

Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial

NCT02988713

Chronic Pain

COMPLETED NA

Effect of Epidural Stimulation on Muscle Activation and Sensory Perception

NCT04157400

Chronic Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This feasibility study assessed the following outcomes:

* Patient satisfaction
* VAS pain scores

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Back Pain Leg Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Spinal Cord Stimulation

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

Group Type EXPERIMENTAL

Spinal Cord Stimulation

Intervention Type DEVICE

Programming

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spinal Cord Stimulation

Programming

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No