Exploring Potential Benefits of Spinal Cord Stimulation for Diabetic Peripheral Neuropathy Beyond Pain Management

Tariq AlFarra, DO1; Harman Chopra, MD2; Mustafa Broachwala, MD2; Oth Tran, MSc3; Yao Ding, PhD3; Sean Li4, MD;

Chris Gilligan, MD5; Timothy Deer, MD6

1Icahn School of Medicine at Mount Sinai, New York, NY; 2John Hopkins Hospital, Baltimore, MD; 3Boston Scientific Corporation, Minneapolis, MN; 4Premier Pain Centers, Shrewsbury, NJ; 5Robert Wood Johnson University Hospital, New Brunswick, NJ; 6Spine and Nerve Center of the Virginias, Charleston, WV, USA

Background

• Spinal cord stimulation (SCS) for pain relief and improved quality of life is well established in chronic low back pain populations.1-3

• While, several studies show pain relief in SCS for diabetic peripheral neuropathy (DPN)4there is a paucity of evidence surrounding correlation between SCS and other diabetic-related (DR) complications.

  Objective

• To examine DR complications among DPN patients with SCS implant versus those continuing conventional medical(CMM) management in the U.S. Medicare population.

  Methods

• Medicare Claims Standard Analytical Files (SAFs) were used to identify patients with chronic pain diagnoses implanted with SCS (first permanent SCS date = index date) or those without SCS (randomly assigned index date matching the distribution of the index dates of the SCS cohort) from 1/1/2017 to 3/31/2021.

• SCS cohort matched 1:3 to non-SCS cohort using propensity score matching based on age, gender, region, Charlson Comorbidity Index, pain type, number of treatments and healthcare visits due to pain.

• Compared DR complications and treatments within 2 years post-index among matched SCS vs non-SCS patients.

Summary of Results

• PDN patients treated with SCS had lower rates of diabetic foot ulcer (6.4% vs 8.9%, p<0.001), diabetic retinopathy (4.8% vs 6.9%, p<0.001), and diabetic nephropathy (6.8% vs 8.1%, p = 0.021) compared to matched non-SCS controls.

• Rate of intervention for foot ulcer (debridement or skin graft) and nephropathy (hemodialysis or renal transplantation) was lower in the SCS cohort (2.9% vs 4.1%, p=0.003; 0.6% vs 1.0%, p=0.050, respectively, shown in Table 2).

Conclusions

• This retrospective nationwide analysis found among chronic pain patients with DPN, SCS patients had lower rates of complications including foot ulcer, retinopathy, and nephropathy compared to non-SCS patients.

• Further studies***

References

1. Lamer TJ, et al. Spinal Stimulation for the Treatment of Intractable Spine and Limb Pain: A Systematic Review of RCTs and Meta-Analysis. Mayo Clin Proc. 2019;94(8):1475-1487.

2. Pollard EM, et al. The effect of spinal cord stimulation on pain medication reduction in intractable spine and limb pain: a systematic review of randomized controlled trials and meta- analysis. J Pain Res. 2019;12:1311-1324.

3. Farber SH, et al. Long-term Cost Utility of Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome. Pain Physician. 2017;20(6):E797-E805.

4. Petersen EA, et al. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy:

A Randomized Clinical Trial. JAMA Neurol. 2021;78(6):687- 698.

Table 2. Diabetic-Related Complications within 2 Years Post-Index

Matched Matched SCS Non-SCS

Control

P-value

Diabetic-related complications (N, %)

Diabetic foot ulcer Diabetic retinopathy Diabetic nephropathy Diabetic polyneuropathy Diabetic mononeuropathy

Diabetic-related complication surgical treatments (N, %)

Debridement or skin graft for foot ulcer
Hemodialysis or renal transplantation for nephropathy

N= 2,981

191 6.4% 144 4.8% 203 6.8%

1,347 45.2% 46 1.5%

86 2.9% 18 0.6%

N= 8,943

800 8.9% 613 6.9% 726 8.1%

3,891 43.5% 136 1.5%

366 4.1% 89 1.0%

183 2.0%

<0.0001 <0.0001 0.021 0.110 0.931

0.003 0.050

0.304

polyneuropathy 52 1.7%

SCS: spinal cord stimulation; The non-SCS controls were on conventional medical management