Peripheral Neurostimulation for Complex Regional Pain Syndrome

Overseen By Jean-Louis Horn, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Chronic pain, Psychiatric, Neuropathy, COPD, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

82 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a chronic pain condition requiring more than 30 milligrams of morphine equivalent daily, you may not be eligible to participate.

What data supports the effectiveness of the treatment B Braun HNS 12 nerve stimulator for Complex Regional Pain Syndrome?

Research shows that peripheral nerve stimulation, similar to the B Braun HNS 12 nerve stimulator, has been effective in reducing pain for patients with Complex Regional Pain Syndrome. In one study, 63% of patients experienced long-term pain relief, and another case showed significant pain reduction from a score of 8-10 to 1-2 out of 10 after treatment. ^{1 2 3 4 5}

Is peripheral nerve stimulation safe for humans?

Peripheral nerve stimulation (PNS) is generally considered safe for treating chronic pain, with studies showing it to be less invasive than surgery and having a high margin of safety. However, there can be hardware-related complications that may require revision. ^{1 6 7 8 9}

How does the B Braun HNS 12 nerve stimulator treatment differ from other treatments for complex regional pain syndrome?

The B Braun HNS 12 nerve stimulator is unique because it uses peripheral nerve stimulation (PNS), which involves placing electrodes on specific nerves to reduce pain. This method is minimally invasive and can provide long-term pain relief, making it different from other treatments that may not target specific nerves or offer sustained results. ^{1 2 3 4 10}

What is the purpose of this trial?

Peripheral nerve blocks are routinely used and highly successful for intra-operative anesthesia and post-operative pain management. Nerve blocks are guided using either neurostimulation as a means to localize the right nerve or by ultrasound guidance or combining the 2 methods. The purpose of this study is to assess whether electrical stimulation improves nerve block quality, beyond its simple purpose of nerve localization.

Eligibility Criteria

This trial is for individuals with Complex Regional Pain Syndrome who need nerve blocks for surgery or pain management. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed requirements.

Inclusion Criteria

I am scheduled for arm surgery with a specific nerve block.

Exclusion Criteria

I am under 18 years old.

Incarceration

My health is severely limited by my disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single shot brachial plexus block with or without peripheral nerve stimulation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including sensory/motor block duration and patient satisfaction

Up to 1 year

Treatment Details

Interventions

• B Braun HNS 12 nerve stimulator

Trial Overview The study tests if using the B Braun HNS 12 nerve stimulator improves the quality of nerve blocks compared to a sham (fake) control. It aims to determine whether electrical stimulation does more than just help find the right nerve during block placement.

Participant Groups

Group I: Ultrasound-guided brachial plexus block with peripheral nerve stimulation Experimental Treatment 1 Intervention

Patients will receive a single shot brachial plexus block with ultrasound guidance as per standard of care, with additional use of the B. Braun HNS 12 nerve stimulator for duration of block placement.

Group II: Ultrasound-guided brachial plexus block without peripheral nerve stimulation Placebo Group 1 Intervention

Patients will receive the single shot brachial plexus block in the same way the first arm would, and the B Braun nerve stimulator will be placed in the same way, but not turned on.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Peripheral nerve stimulation (PNS) is a safe and effective treatment for chronic pain, showing significant reductions in patient-reported pain scores from an average of around 7.4 to approximately 1.6 within the first month and sustained relief for up to 24 months across 57 patients.

Patients also experienced a notable decrease in their use of morphine, indicating that PNS not only alleviates pain but may also reduce reliance on opioid medications, with significant reductions observed at 6, 12, and 24 months post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Peripheral Nerve Stimulation with a High Frequency Electromagnetic Coupled (HF-EMC) Powered Implanted Receiver in Treating Different Pain Targets/Neuralgias. Abd-Elsayed, A., Moghim, R.[2023]

The distal to proximal neurostimulator lead revision technique is a safe and effective method for adjusting lead positions in patients with chronic pain, as demonstrated in a case series of 3 patients.

All patients experienced over 50% pain reduction at long-term follow-up, indicating that this technique can provide significant relief without the need for replacing the entire neurostimulator system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A technique of distal to proximal revision of peripheral neurostimulator leads: technical note. Mammis, A., Mogilner, AY.[2014]

The StimRouter® system is a minimally invasive, FDA-approved treatment for peripheral mononeuropathy that has shown a high margin of safety in multiple clinical trials, making it safer than other systems that require more invasive surgical procedures.

Clinical studies indicate that the StimRouter system effectively reduces pain and improves activity levels and quality of life for patients suffering from chronic peripheral mononeuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the StimRouter® peripheral neuromodulation system for chronic pain management. Regnier, SM., Chen, J., Gabriel, RA., et al.[2021]

Implanting the pulse generator (IPG) closer to the lead location, such as in the infraclavicular region, significantly reduces the incidence of adverse events (AEs) related to peripheral nerve stimulation (PNS) for chronic migraine management, indicating a safer surgical approach.

Increased experience of the implanter, measured by the number of prior PNS implants performed, is associated with a lower rate of stimulation- and hardware-related AEs, suggesting that skill and precision improve with practice, leading to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. Sharan, A., Huh, B., Narouze, S., et al.[2022]

A pilot study involving six patients demonstrated that a novel, wirelessly controlled microstimulator for tibial nerve stimulation significantly reduced pain levels in patients with peripheral neuropathic pain (PNP) and complex regional pain syndrome (CRPS) over a six-month period, with visual analog scale (VAS) scores dropping from an average of 7.5 preoperatively to 1.3 at six months (p=0.02).

The treatment was found to be safe and minimally invasive, with no complications reported, indicating that intermittent tibial nerve stimulation could be a feasible option for managing chronic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tibial nerve stimulation with a miniature, wireless stimulator in chronic peripheral neuropathic pain. Sokal, P., Harat, M., Zieliński, P., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term results of peripheral nerve stimulation for reflex sympathetic dystrophy. [2011]

2. England pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Stimulation of the Brachial Plexus for Chronic Refractory CRPS Pain of the Upper Limb: Description of a New Technique and Case Series. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Stimulation of Brachial Plexus Nerve Roots and Supra-Scapular Nerve for Chronic Refractory Neuropathic Pain of the Upper Limb. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[First Experiences with peripheral Nerve Stimulation using an implantable System as a Treatment Method for the Complex Regional Pain Syndrome CRPS 2]. [2022]

5. Scotland pubmed.ncbi.nlm.nih.gov

Peripheral median nerve stimulation for the treatment of iatrogenic complex regional pain syndrome (CRPS) type II after carpal tunnel surgery. [2009]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy of Peripheral Nerve Stimulation with a High Frequency Electromagnetic Coupled (HF-EMC) Powered Implanted Receiver in Treating Different Pain Targets/Neuralgias. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A technique of distal to proximal revision of peripheral neurostimulator leads: technical note. [2014]

8. England pubmed.ncbi.nlm.nih.gov

A review of the StimRouter® peripheral neuromodulation system for chronic pain management. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Tibial nerve stimulation with a miniature, wireless stimulator in chronic peripheral neuropathic pain. [2020]