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Neurostimulation

Spinal Cord Stimulation for Chronic Pain

N/A
Recruiting
Led By Scott Lempka, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic intractable pain of the trunk and/or limbs
Candidates who are 18 years or older and can speak, read, and understand English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (at randomization) and at the end of each seven-day treatment
Awards & highlights

Study Summary

This trial will study how well different types of electrical spinal cord stimulation work to relieve pain in people who already have it as part of their standard care.

Who is the study for?
This trial is for adults with chronic pain in the trunk or limbs who are already using spinal cord stimulation (SCS) as part of their treatment. Participants must be over 18, speak English, and follow study procedures. They should agree to COVID-19 precautions and not have used nail enhancements recently. Pregnant women and those with recent or current COVID-19 are excluded.Check my eligibility
What is being tested?
The study is testing how different forms of SCS affect pain relief in patients with conditions like Complex Regional Pain Syndrome and neuropathic pain. It involves regular evaluations to understand the impact of SCS on chronic pain management.See study design
What are the potential side effects?
While specific side effects aren't listed here, SCS can sometimes cause discomfort at the implant site, unwanted changes in nerve activity, infection risk from surgery, or equipment malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have ongoing severe pain in my trunk or limbs.
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I am 18 or older and can speak, read, and understand English.
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I am receiving spinal cord stimulation for chronic pain management.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (at randomization) and at the end of each seven-day treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (at randomization) and at the end of each seven-day treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SCS-induced changes in temporal summation (TS)

Trial Design

6Treatment groups
Experimental Treatment
Group I: kHz / Sham / Burst / TonicExperimental Treatment1 Intervention
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Group II: kHz / Burst / Sham / TonicExperimental Treatment1 Intervention
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Group III: Sham / kHz / Burst / TonicExperimental Treatment1 Intervention
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Group IV: Sham / Burst / kHz / TonicExperimental Treatment1 Intervention
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Group V: Burst / kHz / Sham / TonicExperimental Treatment1 Intervention
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Group VI: Burst / Sham / kHz / TonicExperimental Treatment1 Intervention
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal cord stimulation
2022
N/A
~30

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,794 Previous Clinical Trials
6,373,891 Total Patients Enrolled
31 Trials studying Chronic Pain
3,781 Patients Enrolled for Chronic Pain
National Center for Complementary and Integrative Health (NCCIH)NIH
831 Previous Clinical Trials
668,908 Total Patients Enrolled
45 Trials studying Chronic Pain
17,953 Patients Enrolled for Chronic Pain
Scott Lempka, PhDPrincipal Investigator - University of Michigan
University of Michigan
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Chronic Pain
20 Patients Enrolled for Chronic Pain

Media Library

Spinal Cord Stimulation (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04732325 — N/A
Chronic Pain Research Study Groups: kHz / Sham / Burst / Tonic, Burst / kHz / Sham / Tonic, Sham / kHz / Burst / Tonic, Burst / Sham / kHz / Tonic, kHz / Burst / Sham / Tonic, Sham / Burst / kHz / Tonic
Chronic Pain Clinical Trial 2023: Spinal Cord Stimulation Highlights & Side Effects. Trial Name: NCT04732325 — N/A
Spinal Cord Stimulation (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04732325 — N/A

Frequently Asked Questions

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

What is the upper bound of participants in this experiment?

"Affirmative. Clinicaltrials.gov exhibits evidence that this trial, originally posted on the 11th of September 2021, is still in need of volunteers. A single location requires 25 participants to complete its experiment."

Answered by AI

Does this clinical experiment still have vacancies for participants?

"Affirmative. According to clinicaltrials.gov, this experiment is presently recruiting volunteers; it was initially posted on September 11th 2021 and has been modified most recently on October 5th 2022. Approximately 25 patients need to be enrolled from 1 trial centre ."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain
Scott Lempka 2021. "Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04732325.
~7 spots leftby Apr 2025
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