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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
Must not have
Patient refusal
Previous failed spinal cord stimulation trial with either high frequency or burst waveforms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24 and 36 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have chosen not to participate in the trial.
Select...
I have tried spinal cord stimulation without success.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in pain intensity
Secondary study objectives
Anxiety
Depression
Function
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
2,491 Previous Clinical Trials
17,519,093 Total Patients Enrolled
39 Trials studying Chronic Pain
9,789 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