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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
22 years of age or older
Be older than 18 years old
Must not have
If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing different types of stimulations to see what works best for pain relief with the least side effects.
Who is the study for?
This trial is for adults over 22 with limb or back pain, who have had a Medtronic rechargeable neurostimulation system implanted for at least one month. Participants must understand English, be able to follow the study's procedures and document their experience. Pregnant women or those not using birth control are excluded.
What is being tested?
The SCS Research Study is examining how different spinal cord stimulation settings affect pain relief in patients with chronic limb and back pain. It focuses on personalizing treatment by assessing outcomes specific to each participant.
What are the potential side effects?
While the summary doesn't specify side effects, spinal cord stimulation can typically cause discomfort at the site of implantation, unwanted tingling sensations due to stimulation, and potential infection risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or willing to use birth control if I can have children.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 16 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Numeric pain rating scale
Side effects data
From 2019 Phase 4 trial • 30 Patients • NCT0328441110%
Device stimulation issue
3%
Inadequate analgesia
3%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spinal Cord Stimulation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Spinal Cord StimulationExperimental Treatment1 Intervention
Each subject will be programmed to different settings.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal Cord Stimulation
2020
Completed Phase 4
~420
Find a Location
Who is running the clinical trial?
MedtronicNeuroLead Sponsor
71 Previous Clinical Trials
20,775 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are willing and able to comply with all study procedures, including diary completion, and visits.You have a non-rechargeable neurostimulator, and it's impossible to predict how long the battery will last.You have a device implanted in your body that is being used for a purpose that hasn't been approved by the authorities.I have had a Medtronic rechargeable neurostimulator for over a month, and it's expected to last at least 5 more months.You are already participating or planning to participate in another study that could affect the results of this study.You have a serious mental illness that is not currently being treated.I am not pregnant or willing to use birth control if I can have children.I can tell the difference between my usual pain and other types of pain.I am 22 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Spinal Cord Stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Limb Pain Patient Testimony for trial: Trial Name: NCT03763708 — N/A
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