Spinal Cord Stimulation for Back Pain

Center for Interventional Pain and Spine, Lancaster, PA
Back Pain+1 More ConditionsSpinal Cord Stimulation - Device
All Sexes
What conditions do you have?

Study Summary

This trial is testing different types of stimulations to see what works best for pain relief with the least side effects.

Eligible Conditions
  • Back Pain
  • Limb Pain

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Up to 16 months

Up to 16 months
Numeric pain rating scale

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Side Effects for

Spinal Cord Stimulation
10%Device stimulation issue
3%Inadequate analgesia
3%Back pain
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT03284411) in the Spinal Cord Stimulation ARM group. Side effects include: Device stimulation issue with 10%, Inadequate analgesia with 3%, Back pain with 3%.

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1 Treatment Group

Spinal Cord Stimulation
1 of 1

Experimental Treatment

360 Total Participants · 1 Treatment Group

Primary Treatment: Spinal Cord Stimulation · No Placebo Group · Phase 4

Spinal Cord Stimulation
Experimental Group · 1 Intervention: Spinal Cord Stimulation · Intervention Types: Device
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal Cord Stimulation
Completed Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 16 months

Who is running the clinical trial?

MedtronicNeuroLead Sponsor
69 Previous Clinical Trials
20,399 Total Patients Enrolled
3 Trials studying Back Pain
401 Patients Enrolled for Back Pain

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can tell the difference between the pain that the SCS implant is meant to help with and other types of pain.

Who else is applying?

What state do they live in?
North Carolina50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Center for Pain and Supportive Care50.0%
Carolinas Research Institute50.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%

Frequently Asked Questions

Has the FDA sanctioned Spinal Cord Stimulation as a therapeutic option?

"Clinical data has been collected over many years, indicating Spinal Cord Stimulation is a safe procedure. Consequently, it was given the highest rating of 3 on our scale." - Anonymous Online Contributor

Unverified Answer

How many volunteers are participating in the experiment?

"Indeed, the information provided on clinicaltrials.gov demonstrates that this medical experiment is currently searching for participants. This trial was first published in December 2018 and last updated June 2022; it requires 360 subjects across 10 different sites." - Anonymous Online Contributor

Unverified Answer

Are there current openings for this research endeavor?

"That is accurate. According to the details on clinicaltrials.gov, this study was initially posted in December 2018 and recently updated in June 2022. The trial currently seeks 360 participants spread across 10 medical sites." - Anonymous Online Contributor

Unverified Answer

Where is the oversight of this trial administered?

"Ten medical facilities have been selected to participate in this trial, among which are Twin Cities Pain Clinic situated in Edina, University of California San Diego Altman Clinical and Translational Research Institute located in La Jolla, Centre for Interventional Pain and Spine based out of Lancaster. Furthermore, there are several other research sites participating." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.