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Neurostimulation

Neurostimulation + Spinal Fusion for Chronic Pain

N/A
Recruiting
Research Sponsored by SynerFuse, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with chronic, intractable pain of the lower back and/or leg refractory to conservative therapy for at least 3 months
Indicated for a single level or two level adjacent spinal fusion having back pain and radiculopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up surgery to 3, 6, and 12 months post-op
Awards & highlights

Study Summary

This trialstudies the safety of a neurostimulator during a spinal fusion procedure for chronic back and leg pain.

Who is the study for?
This trial is for adults over 21 with chronic lower back or leg pain that hasn't improved after at least 3 months of treatment, who now need spinal fusion surgery. Candidates should not have had previous spinal fusions at the same level, be pregnant, involved in other studies, require future MRIs, have osteoporosis or active infections.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of DRG stimulation combined with spinal fusion surgery in patients suffering from persistent back and/or leg pain. It involves placing a neurostimulator during the surgical procedure to manage pain.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include typical surgical complications like infection or bleeding as well as device-specific issues such as discomfort or malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had severe lower back or leg pain for over 3 months that hasn't improved with basic treatments.
Select...
I need spinal fusion surgery for 1 or 2 levels due to back pain and nerve pain.
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I am 21 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~surgery to 3, 6, and 12 months post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and surgery to 3, 6, and 12 months post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Endpoint: Change in back and leg pain Visual Analog Score (VAS) scores
Primary Safety Endpoint: Characterization of device-related adverse events
Secondary outcome measures
Change in disability measured by the Oswestry Disability Index (ODI).
Change in neurological status
Change in quality of life as measured by EQ-5D-5L.
+2 more
Other outcome measures
Amount of device migration
Costs and cost-effectiveness of the intervention

Trial Design

1Treatment groups
Experimental Treatment
Group I: DRG Neurostimulation with Spinal FusionExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

SynerFuse, IncLead Sponsor

Media Library

DRG Neurostimulation (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04054401 — N/A
Chronic Pain Research Study Groups: DRG Neurostimulation with Spinal Fusion
Chronic Pain Clinical Trial 2023: DRG Neurostimulation Highlights & Side Effects. Trial Name: NCT04054401 — N/A
DRG Neurostimulation (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04054401 — N/A

Frequently Asked Questions

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

Does this clinical trial include participants who are over sixty years of age?

"This research study seeks participants aged 21 to 80 years old."

Answered by AI

What is the current intake of participants for this clinical research initiative?

"Affirmative. According to clinicaltrials.gov, this trial which was inaugurated on 6th of January 2022 is actively enrolling participants. The investigators are seeking 20 study subjects from a single location."

Answered by AI

Is there an opportunity to enroll in this experiment at present?

"Affirmative. According to clinicaltrials.gov, this research initiative was first made available on June 1st 2022 and recently updated in January 9th 2023. The study is recruiting 20 participants from a single trial site."

Answered by AI

Who meets the prerequisites to be part of this investigation?

"Individuals aged 21 to 80 suffering from chronic pain are suitable for this trial. To be eligible, they must have been diagnosed with intractable lower back and/or leg discomfort refractory to conservative treatment over the span of three months; additionally, it needs to have been 6 months since their last spinal operation. Moreover, participants will need demonstrate a willingness sign informed consent documents as well as comply with all other study-related requirements."

Answered by AI

What is the central aim of this investigation?

"This clinical trial's primary endpoint, which will be assessed over a period of 3 months following baseline measurements, is the characterisation of device-related adverse events. Secondary objectives include evaluating changes in quality of life using EQ-5D-5L (with improvement being demonstrated by negative changes), disability determined via Oswestry Disability Index (which has 5 categories representing different levels of impairment) and PROMIS Scale v1.2 - Global Health (wherein higher scores indicate better health)."

Answered by AI

Who else is applying?

What site did they apply to?
South Bend Orthopaedics
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
2022. "SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04054401.
All > Chronic Pain
~3 spots leftby Oct 2024
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