Neurostimulation + Spinal Fusion for Chronic Pain

Recruiting at 1 trial location

Overseen By Gabi Molnar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SynerFuse, Inc

Must not be taking: Narcotics

Disqualifiers: Pregnant, Cancer, Osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Immediate (surgical procedure)

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with persistent back or leg pain unresponsive to regular treatments. It combines DRG neurostimulation, which uses small electrical pulses to manage pain, with spinal fusion surgery to stabilize the spine. This trial targets those experiencing severe back and leg nerve pain, who have not found relief with other therapies for at least three months, and require spinal fusion surgery. Participants should not have undergone previous spinal fusion surgeries at the affected area and should not have conditions like cancer or osteoporosis. The main goal is to determine if this combination treatment is safe and well-tolerated. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for managing chronic pain.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using narcotics at a high dose (100 MME or more per day), you may not be eligible to participate.

What prior data suggests that DRG Neurostimulation with Spinal Fusion is safe for chronic pain patients?

Research has shown that DRG (dorsal root ganglion) neurostimulation is generally safe for treating chronic pain and often helps reduce pain for various conditions. However, the device may need removal over time.

For spinal fusion, the results are less clear. Some reports suggest limited evidence of its effectiveness for chronic lower back pain, though they do not indicate major safety concerns.

In summary, DRG neurostimulation is usually well-tolerated, though device removal can be an issue. Spinal fusion appears safe, but its effectiveness remains debated. Prospective participants should discuss potential risks and benefits with their doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of DRG Neurostimulation with Spinal Fusion for chronic pain because it offers a novel approach that could enhance pain relief beyond traditional methods. Unlike standard treatments like medications and standalone spinal fusion surgery, this approach integrates the precision of DRG Neurostimulation, which targets specific nerve clusters, potentially offering more effective and localized pain management. This dual-action technique might provide a significant improvement in quality of life for those with chronic pain by addressing the pain at its source and stabilizing the spine simultaneously.

What evidence suggests that DRG Neurostimulation with Spinal Fusion could be effective for chronic pain?

Research has shown that stimulating the dorsal root ganglion (DRG) effectively relieves chronic pain. Studies have found that DRG stimulation often surpasses standard spinal cord stimulation (SCS), with patients experiencing fewer changes in sensation during movement. One study found that DRG stimulation provided superior pain relief compared to SCS, particularly for conditions like complex regional pain syndrome (CRPS-I) and low back pain. This trial will evaluate the combination of DRG neurostimulation with spinal fusion, which could offer a promising option for managing chronic back or leg pain. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to comply with study-related requirements

It has been over 6 months since my last spine surgery.

I have had severe lower back or leg pain for over 3 months that hasn't improved with basic treatments.

Exclusion Criteria

Allergies to system components

I currently have an infection.

You might need to have an MRI in the future.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo DRG neurostimulation and spinal fusion procedure

Immediate (surgical procedure)

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and effectiveness of the treatment

12 months

Multiple visits at 3, 6, and 12 months post-op

Long-term follow-up

Participants' use of analgesics, disability, neurological status, quality of life, and device migration are assessed

12 months

What Are the Treatments Tested in This Trial?

Interventions

• DRG Neurostimulation
• Spinal Fusion

Trial Overview 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.

How Is the Trial Designed?

Group I: DRG Neurostimulation with Spinal Fusion Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

SynerFuse, Inc

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

In a study of 66 participants with chronic pain, dorsal root ganglion (DRG) stimulation led to a significant reduction in pain levels, with average pain ratings dropping from 8.0 cm to 4.1 cm after 12 months, and 49% of subjects experiencing at least a 50% reduction in pain.

The treatment also improved functional capacity, mood, and quality of life, with a high success rate of permanent implants (86.2%) and a low incidence of complications such as infections or lead migrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Dorsal Root Ganglion Stimulation in a Prospective Dutch Cohort. Huygen, FJPM., Liem, L., Nijhuis, H., et al.[2022]

Dorsal root ganglion (DRG) stimulation is an emerging treatment for neuropathic pain, but complications during the placement of the device can occur, as illustrated by a case where a catheter fragment was retained in the spinal canal.

The patient required a laminectomy to remove the retained catheter, highlighting the need for further investigation into the safety and long-term complications associated with DRG stimulation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retained catheter during placement of dorsal root ganglion stimulator: a case report. Kohli, G., Amin, S., Herschman, Y., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7079258/

Effectiveness and Safety of Dorsal Root Ganglion ... Our pooled analysis showed high responder rates and effectiveness of DRG neurostimulation for various pain etiologies, mainly CRPS‐I, causalgia, and low back ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S109471592100012X

Three-Year Outcomes After Dorsal Root Ganglion ... Specifically, the pivotal ACCURATE trial showed DRG stimulation to be superior to SCS in alleviating pain and revealed the specificity, positional stability, ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/papr.70010

Comparative efficacy of closed‐loop spinal cord stimulation ... To compare the efficacy of closed-loop spinal cord stimulation (CL-SCS) and dorsal root ganglion (DRG) stimulation in managing chronic cancer-related pain.

4. rapm.bmj.com rapm.bmj.com/content/early/2024/09/10/rapm-2024-105719

Long-term explantation risk in patients with chronic ... Although SCS and DRG stimulation are well-established and safe treatments for chronic pain, the long-term explantation risk remains high.

5. journals.lww.com journals.lww.com/pain/fulltext/2017/04000/dorsal_root_ganglion_stimulation_yielded_higher.14.aspx

Dorsal root ganglion stimulation yielded higher treatment... The results show that DRG stimulation provided a higher rate of treatment success with less postural variation in paresthesia intensity compared to SCS.

6. janesthanalgcritcare.biomedcentral.com janesthanalgcritcare.biomedcentral.com/articles/10.1186/s44158-024-00219-6

addressing persistent doubts in spinal cord stimulation Moreover, there is limited evidence supporting the effectiveness of spinal fusion or disc replacement surgeries in managing chronic lower back ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7065079/

Safety Analysis of Dorsal Root Ganglion Stimulation in the ... Stimulation of the dorsal root ganglion (DRG) in the treatment of chronic, intractable pain has shown excellent clinical results in multiple published studies, ...