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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether electrical stimulation can enhance the effectiveness of nerve blocks for individuals undergoing upper limb surgery. Nerve blocks commonly control pain during and after surgery, and the study aims to determine if adding electrical stimulation during the procedure offers benefits beyond locating the correct nerve. Participants will receive a nerve block either with or without electrical stimulation using the B Braun HNS 12 nerve stimulator to compare results. The trial seeks individuals scheduled for arm surgery who will receive a nerve block as part of their procedure. As an unphased trial, it offers participants the chance to contribute to innovative pain management research.

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 prior data suggests that the B Braun HNS 12 nerve stimulator is safe for use in nerve blocks?

Research shows that peripheral nerve stimulation (PNS) is generally safe for treating long-term pain. It is less invasive than surgery, making it easier on the body. Specifically, the B Braun HNS 12 nerve stimulator is well-tolerated by patients. Studies indicate it includes safety features like alarms and resistance monitoring to protect patients.

Reports of PNS used for 60 days have shown it to be safe and effective for conditions like Complex Regional Pain Syndrome (CRPS). This suggests that the B Braun HNS 12 nerve stimulator is likely a safe option for nerve blocks, with few reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Complex Regional Pain Syndrome (CRPS) involve medications like anti-inflammatories, nerve blocks, or physical therapy to manage symptoms. However, the B Braun HNS 12 nerve stimulator offers a new approach. Unlike traditional methods, this device uses peripheral nerve stimulation, which can enhance the effects of a brachial plexus block by maintaining a gentle twitch during anesthesia administration. Researchers are excited about this technique because it could potentially offer more precise pain management and reduce the need for higher doses of medication, leading to fewer side effects and improved quality of life for patients.

What evidence suggests that the B Braun HNS 12 nerve stimulator is effective for improving nerve block quality in Complex Regional Pain Syndrome?

This trial will compare the use of the B Braun HNS 12 nerve stimulator during nerve blocks with a sham comparator. Research has shown that using the B Braun HNS 12 nerve stimulator during nerve blocks can improve pain management. In a study of similar techniques, 47.5% of patients reported good pain relief, and 7.5% experienced excellent pain relief. This suggests that the device might enhance the effectiveness of nerve blocks by accurately targeting nerves. The stimulator is also designed to improve the overall experience of nerve blocks, potentially relieving pain for patients with conditions like complex regional pain syndrome. Although direct data on this specific device for this condition is limited, positive results from related studies suggest it could be beneficial. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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

Poorly controlled psychiatric condition

Incarceration

I take more than 30 mg of pain medication daily.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Patients will receive a brachial plexus catheter with ultrasound guidance as per standard of care, with additional use of the B. Braun HNS 12 nerve stimulator during the loading dose of local anesthesia to maintain a gentle twitch.

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

Patients will receive the brachial plexus catheter in the same way the first arm would, and the B Braun nerve stimulator will be placed in the same way, but the ground electrode will not be connected to the patient.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

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]

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]

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 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]

Citations

1. bbraunusa.com bbraunusa.com/en/products/b4/stimuplex-hns-12nervestimulator4892098.html

Stimuplex® HNS 12 Nerve Stimulator (4892098) Stimuplex® HNS12 with SENSe is a peripheral nerve stimulator for single and continuous nerve block and was rated the best overall stimulator in a clinical ...

2. bbraun.no bbraun.no/content/dam/catalog/bbraun/bbraunProductCatalog/S/AEM2015/no-no/b98/stimuplex-hns-12brosjyre.pdf

Stimuplex® HNS 12 with SENSe To achieve the best stimulation and most effective blockade we recommend the use of Stimuplex® HNS 12 with our well-proven range of stimulation needles ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8440061/

Long-Term Outcome of Spinal Cord Stimulation in Complex ... CRPS patients: 5% no pain relief, 40% poor pain relief, 47.5% good pain relief, and 7.5% excellent pain relief. 64% of all patients received a ...

4. journals.lww.com journals.lww.com/anar/fulltext/2022/16010/a_prospective_observational_study_of_the_efficacy.27.aspx

A Prospective Observational Study of the Efficacy of... This study aimed to use a peripheral nerve stimulator and a landmark-based technique to give interscalene block (ISB) and superficial cervical plexus block ( ...

5. nysora.com nysora.com/topics/equipment/electrical-nerve-stimulators-localization-peripheral-nerves/

Electrical Nerve Stimulators and Localization of Peripheral ... Electrical nerve stimulation in regional anesthesia is a method of using a low-intensity (up to 5 mA) and short-duration (0.05 to 1 ms) electrical stimulus.

6. withpower.com withpower.com/trial/phase-syndrome-pain-9-2024-33eaf

Peripheral Neurostimulation for Complex Regional Pain Syndrome 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10953611/

Sustained Relief of Complex Regional Pain Syndrome (CRPS ... These three cases suggest that 60-day PNS is a safe and efficacious treatment for CRPS. Keywords: chronic pain, 60-day pns, neurostimulation, ...

8. catalogs.bbraun.com catalogs.bbraun.com/en-01/p/PRID00001835/stimuplex-hns-12

Stimuplex® HNS 12 Nerve stimulator for peripheral nerve blocks. The enlarged full graphic LC-display gives you all necessary information at a glance.

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf5/K052313.pdf

510(k) SummarySocetG - accessdata.fda.gov The nerve stimulator Stimuplex®D HNS 12 is a battery powered peripheral nerve stimulator for localization of nerve fibers in the tissue.