What side effects are associated with this type of intervention?

Common treatments for chronic pain similar to DRG stimulation, such as spinal cord stimulation and nerve blocks, can have several side effects. These may include infection at the implantation site, bleeding, nerve damage, and hardware complications like lead migration or device malfunction. Patients may also experience temporary pain at the implantation site, and in rare cases, neurological complications such as paraparesis. It is important to discuss these potential risks with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for chronic pain, including spinal cord stimulation (SCS), which is similar to DRG stimulation. SCS involves the implantation of a device that sends electrical impulses to the spinal cord to modulate pain signals. Other related neuromodulation techniques include transcutaneous electrical nerve stimulation (TENS) and Scrambler therapy, both of which have shown efficacy in managing chronic pain. Additionally, pharmacologic treatments such as antidepressants (e.g., duloxetine, venlafaxine) and anticonvulsants (e.g., pregabalin, gabapentin) have been approved for chronic pain conditions like neuropathic pain and fibromyalgia.

What other types of research exist?

Promising novel alternatives to DRG stimulation for chronic pain patients include: 1) High-frequency (10-kHz) Spinal Cord Stimulation (SCS), which has shown significant pain relief in clinical trials. 2) Transcutaneous Electrical Nerve Stimulation (TENS), which provides symptomatic relief by modifying pain perception. 3) External Trigeminal Neurostimulation (eTNS), which has been effective in acute migraine therapy and may have applications in chronic pain. 4) Single-pulse Transcranial Magnetic Stimulation (sTMS), which has shown efficacy in reducing headache days and may be beneficial for chronic pain management. 5) Noninvasive Vagus Nerve Stimulation (nVNS), which has shown promise in reducing headache burden and may be explored for chronic pain.

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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

Must not have

Active infection

AGE > 80

Timeline

Screening 3 weeks

Treatment Varies

Follow Up surgery to 3, 6, and 12 months post-op

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to reduce chronic back and leg pain by using a small device that sends electrical signals to specific nerves in the spine. The device is placed during a specific type of back surgery. It aims to block pain signals from reaching the brain, helping patients who haven't found relief from other treatments. This method has been used for a long time to treat chronic pain by sending electrical signals to the spine to block pain signals from reaching the brain.

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.

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.

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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an infection.

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I am over 80 years old.

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I have cancer.

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I have osteoporosis.

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I have had spinal fusion surgery at or near the affected area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ surgery to 3, 6, and 12 months post-op

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Effectiveness Endpoint: Change in back and leg pain Visual Analog Score (VAS) scores

Secondary study objectives

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 study objectives

Amount of device migration

Costs and cost-effectiveness of the intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DRG Neurostimulation with Spinal FusionExperimental Treatment1 Intervention

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Chronic pain treatments often target the modulation of pain signals within the nervous system. For example, DRG (Dorsal Root Ganglion) stimulation works by delivering electrical impulses to the DRG, which can alter pain signal transmission and reduce pain perception. This is crucial for chronic pain patients as it directly addresses the abnormal pain signaling pathways that contribute to persistent pain. Other common treatments include spinal cord stimulation, which also modulates pain signals but at the spinal cord level, and pharmacologic treatments like antidepressants and anticonvulsants that alter neurotransmitter levels to reduce pain. These mechanisms are important because they offer targeted approaches to managing chronic pain, potentially improving quality of life for patients by reducing pain intensity and improving function.