Spinal Cord Stimulation for Phantom Limb Pain

(PhantomLimb Trial)

Overseen By Sydney Bader

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lee Fisher, PhD

Must not be taking: Blood thinners

Disqualifiers: Pregnancy, Serious diseases, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 25

4 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

You must stop taking any medications that thin your blood to participate in the trial.

What data supports the idea that Spinal Cord Stimulation for Phantom Limb Pain is an effective treatment?

The available research shows that Spinal Cord Stimulation (SCS) can effectively reduce phantom limb pain. In one study, patients experienced a 50% reduction in pain on both sides after SCS treatment. Additionally, the use of pain medication decreased by at least 50%, and patients reported significant pain relief. Although there is limited recent literature specifically on SCS for phantom limb pain, these findings suggest that SCS can be a promising option for managing this condition. ^{1 2 3 4 5}

What safety data exists for spinal cord stimulation for phantom limb pain?

Spinal cord stimulation (SCS) is generally considered a safe treatment for various chronic pain conditions, including phantom limb pain. Studies have shown that SCS can improve pain relief, sleep, and function. However, the safety and efficacy of SCS can vary depending on the specific device used, and more research is needed to fully understand these differences. Complications can occur, especially in certain populations like the morbidly obese, but overall, SCS is a reversible and safe option for managing chronic pain. The safety of removing SCS paddle leads is not well-defined, indicating a need for further research in this area. ^{6 7 8 9 10}

Is the treatment Boston Scientific Stimulator Lead a promising treatment for phantom limb pain?

Yes, the Boston Scientific Stimulator Lead, also known as spinal cord stimulation, is a promising treatment for phantom limb pain. Research shows that it can provide significant pain relief when other treatments fail. It has been effective in many cases, with a majority of patients experiencing satisfactory pain relief. ^{2 5 9 11 12}

What is the purpose of this trial?

Individuals with upper-limb amputation usually have intact nerves within the residual limb, and studies have demonstrated that electrical stimulation of those nerves can produce sensations that appear to emanate from the amputated limb. In this study, investigators will examine the sensations that are produced by electrical stimulation of these nerves at the location where they exit the spinal cord. Stimulation of the spinal cord is commonly used to treat intractable back and limb pain, and the procedure includes a test phase in which electrodes are temporarily placed under the skin near the spinal cord and removed at the end of testing. Similarly, in this study, electrodes will be placed near the spinal cord in the upper back and neck, and stimulation will be applied over the course of multiple testing sessions, lasting less than 30 days. The electrodes will be removed at the last day of testing. During each testing session, electrical stimulation will be applied through the electrodes and a series of tests will be performed to determine the types of sensations produced by stimulation. In addition to producing meaningful sensations with electrical stimulation, this study will also test the effect of stimulation on phantom limb sensations and phantom limb pain.

Research Team

Lee Fisher, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults aged 18-70 who have had an upper-limb amputation at least a year ago and can visit the University of Pittsburgh twice weekly for about a month. Pregnant women, those planning to become pregnant, individuals with serious health conditions, or those on blood thinners cannot participate.

Inclusion Criteria

I have an amputation above the wrist.

It has been over a year since my amputation.

Be willing to travel to the University of Pittsburgh at least twice per week for 29 days

Exclusion Criteria

I am not taking blood thinners.

I do not have any serious illnesses that would prevent me from joining this study.

I am not pregnant and do not plan to become pregnant during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Electrode Placement

Electrodes are temporarily placed near the spinal cord under local anesthesia

1 day

1 visit (in-person)

Experimental Sessions

Participants undergo up to 20 experimental sessions to test sensations and effects of spinal cord stimulation

30 days

Up to 20 visits (in-person)

Electrode Removal

Stimulation electrodes are removed at the end of the final experimental session

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in phantom limb sensation and pain after electrode removal

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Boston Scientific Stimulator Lead

Trial Overview The study tests if electrical stimulation via electrodes placed near the spinal cord in the upper back and neck can produce sensations from the amputated limb and reduce phantom limb pain. The procedure involves multiple testing sessions over less than 30 days with temporary electrode placement.

Participant Groups

Group I: Boston Scientific cord stimulator lead Experimental Treatment 1 Intervention

A Boston Scientific Stimulator Lead (PMA P030017) will be placed in the cervical epidural space of ten upper-limb amputees and steered laterally towards the dorsal spinal roots under fluoroscopic guidance.

Boston Scientific Stimulator Lead is already approved in United States, European Union for the following indications:

Approved in United States as Boston Scientific Stimulator Lead for:

• Failed Back Surgery Syndrome (FBSS)
• Chronic Pain
• Complex Regional Pain Syndrome
• Intractable Angina
• Visceral Abdominal and Perineal Pain
• Pain in the Extremities from Nerve Damage

Approved in European Union as Boston Scientific Stimulator Lead for:

• Peripheral Ischemic Pain
• Failed Back Surgery Syndrome (FBSS)
• Chronic Pain
• Complex Regional Pain Syndrome

Who Is Running the Clinical Trial?

Lee Fisher, PhD

Lead Sponsor

Trials

4

Recruited

70+

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Findings from Research

Spinal cord stimulation (SCS) has been successfully used to treat phantom limb pain (PLP) and critical lower limb ischemia in three patients, resulting in a 50% reduction in pain for both limbs after treatment.

The therapy showed promising outcomes, including increased transcutaneous oxygen levels and a significant decrease in opioid use, suggesting SCS can be an effective option when traditional medical therapies fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation Therapy for the Treatment of Concomitant Phantom Limb Pain and Critical Limb Ischemia. De Caridi, G., Massara, M., Serra, R., et al.[2022]

In a study of four patients with intractable phantom limb pain, spinal cord stimulation (SCS) resulted in over 80% pain relief for three patients, demonstrating its potential efficacy as a treatment option.

While SCS was generally well-received, with most patients expressing satisfaction, there were complications such as allergic reactions and infections, highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of spinal cord stimulation in the treatment of phantom limb pain: case series and review of the literature. Viswanathan, A., Phan, PC., Burton, AW.[2022]

The ESTIMET trial is a multicenter, randomized study comparing the efficacy of monocolumn versus multicolumn spinal cord stimulation (SCS) in patients with failed back surgery syndrome (FBSS) and significant back pain, involving 115 patients across 14 centers in France.

The primary goal is to assess whether multicolumn SCS can achieve a greater than 50% reduction in low back pain severity at 6 months, addressing a common limitation of traditional SCS in managing back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study). Roulaud, M., Durand-Zaleski, I., Ingrand, P., et al.[2016]

A patient with debilitating bilateral phantom limb pain experienced complete pain relief after upgrading from a constant voltage spinal cord stimulator (SCS) to a constant current system, along with the addition of percutaneous leads.

This case suggests that modifying existing SCS systems by changing the generator type and adding leads can effectively address evolving pain patterns in patients with phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complete coverage of phantom limb and stump pain with constant current SCS system: a case report and review of the literature. Bunch, JR., Goldstein, HV., Hurley, RW.[2018]

In a study of five patients with chronic neuropathic pain, direct spinal-cord stimulation (SCS) paddle lead placement during the trial period resulted in significant and sustained pain relief, with preoperative visual analogue scale (VAS) scores improving from 9.4 to 1.4 after a mean follow-up of 23.6 months.

This technique not only avoided complications associated with lead migration and positional variations but also effectively addressed issues related to epidural scarring, suggesting it could be a reliable and cost-effective method for SCS lead placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paddle-Lead Spinal-Cord Stimulation Surgeries for Chronic Neuropathic Pain: A Single Surgeon Case-Series Outcome Analysis in Indian Population. Baruah, S., Banerjee, AD.[2023]

Spinal cord stimulation (SCS) is effective in improving pain relief, sleep quality, and functional activities in patients with chronic pain, as shown by a survey of 30 patients who reported positive outcomes after receiving different SCS devices.

While there were no significant differences in pain relief and sleep improvement among the three SCS device manufacturers (Medtronic, Advanced Bionics, and ANS), the Advanced Bionics group showed less functional improvement compared to the other two groups, suggesting that device technology may influence certain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. Haddadan, K., Krames, ES.[2022]

In a study of 35 patients who underwent spinal cord stimulator (SCS) paddle removal, the procedure was performed safely with a low complication rate, reporting only two cases of superficial infections that were easily treated with antibiotics.

The use of neuromonitoring and fluoroscopy during the procedure contributed to the minimal risk, demonstrating that SCS paddle removal can be effectively managed with careful surgical techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads. Topp, G., Harland, T., Spurgas, M., et al.[2022]

Paddle lead spinal cord stimulation (SCS) is a safe option for morbidly obese patients, with a low complication rate of 4% for infections and 13% for superficial wound dehiscence, and no neurological complications reported in a study of 67 patients.

Patients experienced a significant reduction in pain scores after the procedure, decreasing from an average of 7.9 preoperatively to 5.7 postoperatively, indicating that SCS can effectively alleviate chronic pain in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paddle Lead Spinal Cord Stimulation in the Morbidly Obese Patient Population: Outcomes and Complications in a Single-Surgeon Cohort. Bharthi, R., Rogowski, BC., Moran, M., et al.[2023]

A prospective study involving 45 patients with failed back surgery syndrome (FBSS) demonstrated that a hybrid spinal cord stimulation (SCS) lead effectively alleviated both low back and leg pain, with significant reductions in pain scores after six months.

The average visual analog scale (VAS) scores dropped from 8.0 for leg pain and 7.5 for low back pain at baseline to 3.2 and 3.5, respectively, indicating substantial pain relief and a decrease in pain medication usage, confirming the safety and efficacy of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation with hybrid lead relieves pain in low back and legs. de Vos, CC., Dijkstra, C., Lenders, MW., et al.[2022]

In a study of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

In a study involving 49 patients with resistant deafferentation pain, spinal cord stimulation (SCS) was effective, with 57% of those who received permanent implants reporting over 75% pain relief after an average follow-up of 5.5 years.

The procedure had a low incidence of side effects, with only two cases requiring replacement of the stimulator due to electrode dislodgement and wire extrusion, indicating a relatively safe profile for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation in deafferentation pain. Sánchez-Ledesma, MJ., García-March, G., Diaz-Cascajo, P., et al.[2018]

Spinal cord stimulation (SCS) may provide pain relief for phantom limb pain (PLP), but the evidence is mixed based on a systematic review of 12 studies.

Due to the small number of patients in each study, more research is necessary to confirm the effectiveness of SCS as a treatment for PLP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on the treatment of phantom limb pain with spinal cord stimulation. Aiyer, R., Barkin, RL., Bhatia, A., et al.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation Therapy for the Treatment of Concomitant Phantom Limb Pain and Critical Limb Ischemia. [2022]

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

Use of spinal cord stimulation in the treatment of phantom limb pain: case series and review of the literature. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study). [2016]

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

Complete coverage of phantom limb and stump pain with constant current SCS system: a case report and review of the literature. [2018]

5. India pubmed.ncbi.nlm.nih.gov

Paddle-Lead Spinal-Cord Stimulation Surgeries for Chronic Neuropathic Pain: A Single Surgeon Case-Series Outcome Analysis in Indian Population. [2023]

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

The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. [2022]

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

Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads. [2022]

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

Paddle Lead Spinal Cord Stimulation in the Morbidly Obese Patient Population: Outcomes and Complications in a Single-Surgeon Cohort. [2023]

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

Spinal cord stimulation with hybrid lead relieves pain in low back and legs. [2022]

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

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation in deafferentation pain. [2018]

12. England pubmed.ncbi.nlm.nih.gov

A systematic review on the treatment of phantom limb pain with spinal cord stimulation. [2018]