Patients and Methods
Abbreviations and Acronyms:CMM (conventional medical management), DN4 (Douleur Neuropathique), DSPN (diabetic sensorimotor peripheral neuropathy), EQ-5D-5L (EuroQol 5-Dimension 5-Level questionnaire), HbA1c (hemoglobin A1c), HRQoL (health-related quality of life), IPG (implantable pulse generator), NNT (number needed to treat), PDN (painful diabetic neuropathy), RCT (randomized controlled trial), SCS (spinal cord stimulation), VAS (visual analog scale)
- Boulton A.J.
- Armstrong D.G.
- Albert S.F.
- et al.
- Rastogi A.
- Goyal G.
- Kesavan R.
- et al.
- Bril V.
- England J.
- Franklin G.M.
- et al.
Patients and Methods
Key Inclusion Criteria
Randomization and Follow-up
- Boulton A.J.
- Armstrong D.G.
- Albert S.F.
- et al.
- England J.D.
- Gronseth G.S.
- Franklin G.
- et al.
Conventional Medical Management
|Characteristic||10-kHz SCS+CMM n=104||CMM crossover to 10-kHz SCS n=77||CMM continuers n=18|
|Age (y), mean ± SD||60.5±11.3||60.3±10.1||62.4±10.3|
|Female, n (%)||38 (37%)||27 (35%)||6 (33%)|
|Male, n (%)||66 (63%)||50 (65%)||12 (67%)|
|White, n (%)||81 (77.9%)||66 (85.7%)||13 (72.2%)|
|Black or African American, n (%)||15 (14.4%)||8 (10.4%)||3 (16.7%)|
|Native Hawaiian or other Pacific Islander, n (%)||3 (2.9%)||1 (1.3%)||0|
|American Indian or Alaska Native, n (%)||2 (1.9%)||0||0|
|Asian, n (%)||1 (1.0%)||1 (1.3%)||0|
|Other, n (%)||2 (1.9%)||1 (1.3%)||2 (11.1%)|
|Type 1, n (%)||8 (8%)||3 (4%)||0|
|Type 2, n (%)||96 (92%)||74 (96%)||18 (100%)|
|Diabetes, mean ± SD||13.1±8.5||12.5±9.1||11.7±6.8|
|Peripheral neuropathy, mean ± SD||7.5±5.8||6.8±4.9||7.6±5.9|
|HbA1c, mean ± SD||7.3%±1.1%||7.5%±1.2%||7.2%±1.0%|
|<7.0%, n (%)||40 (38%)||30 (39%)||7 (39%)|
|<8.0%, n (%)||73 (70%)||53 (69%)||15 (83%)|
|BMI (kg/m2), mean ± SD||33.7±5.3||34.0±5.3||34.1±5.0|
|Lower limb pain VAS (cm), mean ± SD||7.6±1.6||7.2±1.6||6.1±1.3|
|<7.5 cm, n (%)||48 (46%)||38 (49%)||17 (94%)|
|≥7.5 cm, n (%)||56 (54%)||39 (51%)||1 (6%)|
|Severity of neuropathic pain|
|DN4, mean ± SD||6.6±1.7||6.4±2.0||6.6±1.9|
|<4, n (%)||2 (2%)||5 (7%)||1 (6%)|
|≥4, n (%)||102 (98%)||71 (93%)||17 (94%)|
Pain Relief and Neurologic Function
Crossover to 10-kHz SCS after 6 mos
|Baseline||6 mos||12 mos||Baseline||6 mos||12 mos|
|mean ± SD||7.5%±1.2%||7.6%±1.4%||7.3%±1.2%||7.5%±1.1%||7.6%±1.3%||7.6%±1.2%|
|Lower limb pain, n||84||58|
|10-cm pain VAS score (cm), mean ± SD||7.6±1.6||1.7±1.9||1.7±1.8||7.2±1.6||7.4±1.6||2.0±1.6|
|Percent change from baseline, mean ± SD||-||−76%±26%||−77%±25%||-||7%±32%||−70%±27%|
|Proportion of responders (%)||-||86%||86%||-||0||84%|
|Total score, mean ± SD||6.6±1.8||3.4±2.4||3.5±2.3||6.6±2.0||6.7±2.1||3.5±2.4|
|Proportion with score ≥4 (%)||97%||51%||51%||96%||92%||46%|
|Proportion with score <4 (%)||3%||49%||49%||4%||8%||54%|
|Continuous pain, mean ± SD||5.2±2.5||1.6±1.7||1.6±2.0||5.4±2.6||5.7±2.4||1.7±1.6|
|Intermittent pain, mean ± SD||5.4±2.5||1.7±2.1||1.5±1.9||5.6±2.2||6.0±2.5||1.4±1.6|
|Neuropathic pain, mean ± SD||5.5±2.0||1.9±1.6||1.9±1.7||5.4±2.1||5.7±2.1||1.9±1.5|
|Affective descriptors, mean ± SD||4.0±2.7||1.1±1.6||1.0±1.7||3.6±2.7||4.6±2.7||0.7±1.1|
|Total, mean ± SD||5.1±2.0||1.6±1.6||1.6±1.7||5.1±2.0||5.6±2.1||1.5±1.3|
|Neurological assessment, n||76||52|
|Proportion with overall improvement (%)||-||59%||68%||-||0%||62%|
|Proportion with sensory improvement (%)||-||56%||66%||-||4%||58%|
|Overall health VAS, mean ± SD||58.7±18.7||73.3±16.1||75.6±18.6||58.1±21.1||56.8±20.3||75.4±14.6|
|Index, mean ± SD||0.644±0.145||0.767±0.131||0.780±0.123||0.630±0.132||0.604±0.144||0.761±0.087|
|Satisfaction, mean ± SD||3.0±0.7||2.2±0.8||2.0±0.8||3.0±0.8||3.2±0.7||2.2±0.8|
|Impact, mean ± SD||2.5±0.7||1.9±0.7||1.8±0.6||2.7±0.7||2.7±0.6||1.9±0.5|
|Worry: social/vocational, mean ± SD||1.7±0.7||1.4±0.6||1.4±0.6||1.7±0.6||1.7±0.7||1.3±0.4|
|Worry: diabetes-related, mean ± SD||2.1±0.8||1.8±0.8||1.6±0.7||2.3±0.8||2.4±0.9||1.8±0.7|
|Total, mean ± SD||2.5±0.6||1.9±0.6||1.8±0.6||2.6±0.7||2.7±0.6||1.9±0.5|
|Better, great deal better (%)||-||72%||79%||-||0%||77%|
|Little, somewhat, moderately better (%)||-||27%||20%||-||5%||19%|
|No change, almost the same (%)||-||1%||1%||-||95%||4%|
|Better, great deal better (%)||-||67%||73%||-||0%||71%|
|Little, somewhat, moderately better (%)||-||32%||23%||-||7%||28%|
|No change, almost the same (%)||-||1%||5%||-||93%||2%|
Health-related Quality of Life
|PDN treatment||Number needed to treat|
The number needed to treat represents the number of patients that need to be treated with an intervention to achieve 1 more responder with at least 50% pain relief compared with the control intervention. Finnerup et al12 completed a systematic review and meta-analysis of randomized controlled trials for neuropathic pain medications vs placebo. The current study results were used to calculate the number needed to treat for 10-kHz SCS compared with continued conventional medical management.
|High-concentration (8%) capsaicin patches||10.6 (7.4-19)|
|Gabapentin, extended-release||8.3 (6.2-13.0)|
|Serotonin-norepinephrine reuptake inhibitors||6.4 (5.2-8.4)|
|Weak opioid agonists||4.7 (3.6-6.7)|
|Strong opioid agonists||4.3 (3.4-5.8)|
|Tricyclic antidepressants||3.6 (3.0-4.4)|
Potential Competing Interests
Supplemental Online Material
- Supplemental Data
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Grant Support: The work was supported by Nevro Corp .
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