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Procedure

Spinal Cord Stimulation for Chronic Lower Back Pain

N/A

Recruiting

Led By Jeannie Bailey, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to get in and out of chair unassisted

Stable dose of their medications within 2 weeks of study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 hours

Awards & highlights

Study Summary

This trial will investigate whether transcutaneous spinal cord stimulation (tSCS) is a feasible and effective treatment for chronic low back pain (cLBP). If tSCS is found to be efficacious, it may be advantageous due to its non-invasive nature.

Who is the study for?

This trial is for individuals with chronic lower back pain who can get in and out of a chair on their own. They shouldn't have had any medication changes or started new ones within two weeks before joining the study. People with a BMI over 28, spinal hardware from past surgeries, epidural stimulation leads, other neuromuscular pain conditions, intolerance to electrical stimulation, or moderate/severe depression are excluded.Check my eligibility

What is being tested?

The trial is testing tSpinalStim (transcutaneous spinal cord stimulation) as a non-invasive treatment for chronic low back pain. It aims to see if this method can improve patient-reported outcomes like pain scores and objective measures such as sit-to-stand biomechanics without requiring surgical implantation.See study design

What are the potential side effects?

Potential side effects may include discomfort at the site of stimulation or skin irritation due to the transcutaneous device's electrodes. Since it's non-invasive, there are fewer risks compared to surgically implanted devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can get in and out of a chair without help.

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My medication doses have not changed in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Default Mode Network connectivity

Hip/Pelvis Max Flex/Ext angle

Hip/Pelvis Max velocity

+8 more

Secondary outcome measures

Erector Spinae activation (Root Mean Square)

Shank/Ankle Max Flex/Ext angle

Shank/Ankle Max velocity

Trial Design

1Treatment groups

Experimental Treatment

Group I: tSpinalStimExperimental Treatment1 Intervention

Individuals in this arm will receive spinal cord stimulation

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,505 Total Patients Enrolled

National Science Foundation Center for Disruptive Musculoskeletal InnovationsUNKNOWN

Jeannie Bailey, PhDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Transcutaneous Spinal Cord Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05265000 — N/A

Chronic Lower Back Pain Research Study Groups: tSpinalStim

Chronic Lower Back Pain Clinical Trial 2023: Transcutaneous Spinal Cord Stimulation Highlights & Side Effects. Trial Name: NCT05265000 — N/A

Transcutaneous Spinal Cord Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05265000 — N/A

Chronic Lower Back Pain Patient Testimony for trial: Trial Name: NCT05265000 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I qualified to participate in this experiment?

"This experiment is inviting 50 people aged between 21 and 85 with low back pain to participate. Other eligibility criteria includes the ability to independently rise from a chair, no recent changes in medication intake, as well having maintained a stable dose of medications for two weeks preceding enrolment."

Answered by AI

What is the current enrollment size of this research experiment?

"Affirmative. Clinicaltrials.gov furnishes information indicating that this clinical trial is actively searching for patients, having been originally posted on August 1st 2022 and last modified on November 17th 2022. The recruitment process seeks 50 participants from a single medical site."

Answered by AI

Does the age criterion for this research encompass individuals of fifty years and older?

"This trial requires applicants to be between 21 and 85 years old. In contrast, there are 11 research studies for minors and 264 investigations exclusively intended for elderly persons."

Answered by AI

Is there still availability for individuals to join this scientific investigation?

"Affirmative, the facts hosted on clinicaltrials.gov validate that this research is currently in its recruitment phase. The trial was published on 8/1/2022 and most recently modified 11/17/2022 with a sample size of 50 patients from 1 site."

Answered by AI

Who else is applying?

What state do they live in?

California

What site did they apply to?

San Francisco VA Medical Center

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

Have had back pain for almost 30 years... Chronic lower back pain has not responded to various treatments including PT, chiropractic, medication, epidural injections, stem cell and RF ablation.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain

2022. "Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05265000.

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