Indirect Comparison of 10 kHz Spinal Cord Stimulation (SCS) versus Traditional Low-Frequency SCS for the Treatment of Painful Diabetic Neuropathy: A Systematic Review of Randomized Controlled Trials
Abstract
:1. Introduction
2. Materials and Methods
2.1. Eligibility
2.2. Search Strategy
2.3. Selection Process
2.4. Data Extraction and Outcomes
2.5. Study Risk of Bias Assessment
2.6. Measures of Treatment Effect
2.7. Statistical Analysis
2.7.1. Analysis Populations
2.7.2. Mean Pain Intensity Reduction
2.7.3. Responder Rate
2.7.4. Adverse Events
3. Results
3.1. Study Selection
3.2. Study Characteristics
3.3. Risk of Bias in Studies
3.4. Pain Intensity Outcomes
3.5. Responder Rate Outcomes
3.6. Treatment-Related Adverse Events
4. Discussion
4.1. Interpretation of Results
4.2. Treatment-Related Adverse Events
4.3. Strengths and Limitations of the Review
4.4. Implications for Practice, Policy, and Future Research
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Study | |||
---|---|---|---|
Characteristic | Petersen et al. [38] | Slangen et al. [39] | de Vos et al. [40] |
Centers (Countries) | 18 (USA) | 2 (NL) | 7 (NL, DK, BE, DE) |
SCS modality | 10 kHz SCS Paresthesia-free (Nevro) | LF-SCS Continuous paresthesia (Medtronic) | LF-SCS Continuous paresthesia (St. Jude Medical) |
Comparison | 10 kHz SCS + CMM vs. CMM | LF-SCS + CMM vs. CMM | LF-SCS + CMM vs. CMM |
Blinding | No | No | No |
Follow-up duration | 6 mo | 6 mo | 6 mo |
Indication, pain area | PDN, LL | PDN, LL | PDN, LE |
Pain rating scale | VAS (0–10 cm) | NRS (0–10 points) | VAS (0–100 points) |
Pain inclusion criteria | LL VAS ≥ 5 cm | LL NRS ≥ 5 points | LE VAS ≥ 50 points |
Pain exclusion criteria | UL VAS ≥ 3 cm | UL NRS > 3 points | UE Pain > 20 points |
Randomization ratio | 1:1 | 3:2 | 2:1 |
Mean age by group | 10 kHz SCS + CMM: 60.7 ± 11.4 y CMM: 60.8 ± 9.9 y | LF-SCS + CMM: 57.1 ± 12.4 y CMM: 56.5 ± 8.0 y | LF-SCS + CMM: 58 ± 11 y CMM: 61 ± 12 y |
Female/male proportion by group | 10 kHz SCS + CMM: 38%/62% CMM: 36%/64% | LF-SCS + CMM: 32%/68% CMM: 36%/64% | LF-SCS + CMM: 37.5%/62.5% CMM: 35%/65% |
Diabetes Type I/II proportion by group | 10 kHz SCS + CMM: 7%/93% CMM: 3%/97% | LF-SCS + CMM: 14%/86% CMM: 7%/93% | LF-SCS + CMM: 25%/75% CMM: 25%/75% |
Diabetes durationby group | 10 kHz SCS + CMM: 12.9 ± 8.5 y CMM: 12.2 ± 8.5 y | LF-SCS + CMM: 12.7 ± 10.1 y CMM: 12.6 ± 7.2 y | LF-SCS + CMM: 16 ± 11 y CMM: 17 ± 12 y |
Duration of pain or peripheral neuropathyby group | 10 kHz SCS + CMM: 7.4 ± 5.7 y ‡ CMM: 7.1 ± 5.1 y ‡ | LF-SCS + CMM: 6.0 ± 5.1 y † CMM: 4.9 ± 3.6 y † | LF-SCS + CMM: 7 ± 6 y † CMM: 7 ± 6 y † |
Duration of temporary stimulation trial | 5–7 d | 2 w | Up to 1 w |
n randomized by group | 10 kHz SCS + CMM: 113 CMM: 103 | LF-SCS + CMM: 22 CMM: 14 | LF-SCS + CMM: 40 CMM: 20 |
SCS group n trialed n with ≤50% pain relief n with ≥50% pain relief n implanted | 104 6 98 90 # | 22 * 4 17 17 | 40 3 37 37 |
SCS group Proportion with a successful trial | 94% | 77% | 92.5% |
SCS group Trial-to-permanent implant proportion | 87% | 77% | 92.5% |
LF-SCS Group | ||||
---|---|---|---|---|
Statistic | 10 kHz SCS [38] | Slangen LF-SCS ‡ [39] | de Vos LF-SCS [40] | Pooled LF-SCS † [39,40] |
mITT population ∫ | 104 | 22 | 40 | 62 |
Mean baseline pain score | 7.6 | 7.1 | 7.3 | 7.2 |
Mean reduction in pain score at 6 months (95% CI) * | −5.60 (−6.09, −5.11) | −2.73 (−4.02, −1.44) | −4.20 (−5.19, −3.21) | −3.42 (−3.95, −2.89) |
p-value § 10 kHz SCS vs. LF-SCS group | p < 0.0001 | p = 0.0060 | p < 0.0001 | |
Percentage reduction in pain relative to baseline | 73.7% | 38.7% | 57.5% | 47.5% |
LF-SCS Group | ||||
---|---|---|---|---|
Statistic | 10 kHz SCS [38] | Slangen LF-SCS [39] | de Vos LF-SCS [40] | Pooled LF-SCS [39,40] |
Number of responders * | 75 | 9 | 25 | 34 |
mITT population † | 104 | 22 | 40 | 62 |
Proportion of responders (%) ‡ | 72.12% | 40.91% | 62.50% | 54.84% |
RR (95% CI) 10 kHz SCS vs. LF-SCS group | 1.76 (1.05, 2.95) | 1.15 (0.88, 1.51) | 1.32 (1.02, 1.70) | |
p-value § | p = 0.016 | p = 0.1478 | p = 0.018 |
LF-SCS Group | ||||
---|---|---|---|---|
Statistic | 10 kHz SCS [38] | Slangen LF-SCS [39] | de Vos LF-SCS [40] | Pooled LF-SCS [39,40] |
Number of responders * | 75 | 9 | 25 | 34 |
Permanent implant Population † | 90 | 17 | 37 | 54 |
Proportion of responders (%) ‡ | 83.33% | 52.94% | 67.57% | 62.96% |
RR (95% CI) 10 kHz SCS vs. LF-SCS group | 1.57 (1.00, 2.49) | 1.23 (0.97, 1.57) | 1.32 (1.06, 1.66) | |
p-value § | p = 0.026 | p = 0.044 | p = 0.0072 |
Study | ||||||
---|---|---|---|---|---|---|
Petersen et al. [38] | Petersen et al. † [50] | Slangen et al. [39] | van Beek et al. § [41] | van Beek et al. §‡ [42] | de Vos et al. [40] | |
Follow-up Duration | 6 mo | 12 mo | 6 mo | 24 mo | 60 mo | 6 mo |
n | 90 implanted | 154 implanted * | 17 implanted | 17 implanted | 40 implanted | 37 implanted |
Postimplant infection n patients (%) | 3 (3.3%) | 8 (5.2%) | 6 w: 1 (5.9%) | 6 w: 1 (5.9%) | 6 w and 2 mo: 2 (5.0%) | 0 ⌃ |
Lead migration n patients (%) | 1 (1.1%) | 1 (0.6%) | - | - | - | 1 (2.7%) |
IPG site pain n patients | 1 (1.1%) | - | - | - | 10 (25.0%) | 2 (5.4%) |
Uncomfortable stimulation n patients (%) | 1 (1.1%) | - | - | - | 9 (22.5%) | - |
Lead revision n patients (%) | - | 1 (0.6%) | - | 4 (23.5%) | 4 (10.0%) | Due to lead migration: 1 (2.7%) Due to incomplete paresthesia overlap: 2 (5.4%) |
Lead replacement n patients (%) | - | - | - | - | 3 (7.5%) | - |
IPG revision n patients (%) | 2 (1.3%) | - | » | Due to prolonged pocket pain (20 mo): 1 (2.5%) | Due to IPG site pain: 2 (5.4%) | |
IPG explant due to AE n patients (%) | 2 (2.2%) | Due to infection: 5 (3.2%) | Due to postimplant infection: 1 (5.9%) | Due to postimplant infection: 1 (5.9%) | Due to infection: 2 (5.0%) Due to lack of efficacy: 6 (15.0%) | - |
IPG replacement n patients (%) | 0 ψ | 0 ψ | 0 ψ | 1 × replacement: 2 (11.8%) | 1 × replacement: 8 (20.0%) 2 × replacements: 5 (12.5%) | |
Other n patients (%) | Wound dehiscence: 2 (2.2%) Impaired healing: 1 (1.1%) Device extrusion: 1 (1.1%) Incision site pain: 1 (1.1%) Other: 7 (7.8%) ∫ | - | Dural puncture with subdural hematoma sequala, leading to death: 1 (5.9%) | - | - | Coagulopathy during implantation: 1 (2.7%) |
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Hoelzer, B.C.; Edgar, D.; Lu, S.-P.; Taylor, R.S. Indirect Comparison of 10 kHz Spinal Cord Stimulation (SCS) versus Traditional Low-Frequency SCS for the Treatment of Painful Diabetic Neuropathy: A Systematic Review of Randomized Controlled Trials. Biomedicines 2022, 10, 2630. https://doi.org/10.3390/biomedicines10102630
Hoelzer BC, Edgar D, Lu S-P, Taylor RS. Indirect Comparison of 10 kHz Spinal Cord Stimulation (SCS) versus Traditional Low-Frequency SCS for the Treatment of Painful Diabetic Neuropathy: A Systematic Review of Randomized Controlled Trials. Biomedicines. 2022; 10(10):2630. https://doi.org/10.3390/biomedicines10102630
Chicago/Turabian StyleHoelzer, Bryan C., Deborah Edgar, Shiao-Ping Lu, and Rod S. Taylor. 2022. "Indirect Comparison of 10 kHz Spinal Cord Stimulation (SCS) versus Traditional Low-Frequency SCS for the Treatment of Painful Diabetic Neuropathy: A Systematic Review of Randomized Controlled Trials" Biomedicines 10, no. 10: 2630. https://doi.org/10.3390/biomedicines10102630