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Spinal Cord Stimulation
Spinal Cord Stimulation Techniques for Chronic Pain
N/A
Waitlist Available
Led By Vafi Salmasi, MD.
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult English-speaking patient 18 years old or above
Persistent pain in lower back and/or leg for more than six months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24 and 36 months
Awards & highlights
Study Summary
This trial aims to compare the effectiveness of two different types of spinal cord stimulation in improving pain and function in patients with chronic back and/or leg pain.
Who is the study for?
This trial is for English-speaking adults over 18 with chronic lower back or leg pain lasting more than six months, who are recommended for spinal cord stimulation by Stanford's Pain Management Center. It excludes those who refuse to participate, have motor weakness in the lower body, or had a previous failed spinal cord stimulation trial.Check my eligibility
What is being tested?
The study compares two types of spinal cord stimulations: high frequency and burst waveforms. It aims to determine which is more effective for long-term pain relief and function improvement in patients with chronic pain using an innovative data system called CHOIR.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks of spinal cord stimulation can include infection at the implant site, bleeding, headache, allergic reaction to device materials, and temporary pain from the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and speak English.
Select...
I have had lower back or leg pain for over six months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12, 24 and 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 24 and 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pain intensity
Secondary outcome measures
Anxiety
Depression
Function
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: High frequency spinal cord stimulationExperimental Treatment1 Intervention
Implant of the device that can deliver high frequency waveform to spinal cord
Group II: Burst spinal cord stimulationExperimental Treatment1 Intervention
Implant of the device that can deliver burst waveform to spinal cord
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,387 Previous Clinical Trials
17,333,890 Total Patients Enrolled
36 Trials studying Chronic Pain
9,073 Patients Enrolled for Chronic Pain
Vafi Salmasi, MD.Principal Investigator - Stanford University
Stanford University
1 Previous Clinical Trials
320 Total Patients Enrolled
1 Trials studying Chronic Pain
320 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older and speak English.I have chosen not to participate in the trial.I have had lower back or leg pain for over six months.I am recommended for spinal cord stimulation based on a team's advice.I have tried spinal cord stimulation without success.You have weakness in your lower body as determined by the doctors who are treating your pain.
Research Study Groups:
This trial has the following groups:- Group 1: High frequency spinal cord stimulation
- Group 2: Burst 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.
Chronic Pain Patient Testimony for trial: Trial Name: NCT03681262 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is this clinical trial currently accommodating?
"Right, the clinicaltrial.gov website indicates that this medical experiment is currently enlisting individuals. Initially posted on August 1st 2019 and revised most recently on May 3rd 2022, 160 participants need to be enrolled from a single site."
Answered by AI
Is this research still accepting participants?
"As indicated on clinicaltrials.gov, this medical trial is presently recruiting participants. The research was first published on August 1st 2019 and the most recent update occurred on May 3rd 2022."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Stanford Pain Management Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Medication, five steroidal epidural injections and radio-frequency ablation have not offered pain relief for several chronic lower-back herniated discs, the most-acute being L5-S1.
PatientReceived 1 prior treatment
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