Table 2

Outcomes in the SCS group compared with BMT group at 6 months, ITT analysis

Baseline6 months
OutcomesSCS group (N = 22)BMT group (N = 14)SCS group (N = 19)BMT group (N = 14)
HbA1c (mmol/mol)66.9 ± 22.168.6 ± 29.464.2 ± 15.172.1 ± 25.2
HbA1c (%)8.3 ± 2.08.4 ± 2.710.9 ± 8.08.8 ± 2.3
NRS ≥50% pain reduction day (n/total n [%])9/22 (41)0/14 (0)***
NRS ≥50% pain reduction night (n/total n [%])8/22 (36)1/14 (7)**
PGIC for pain (n/total n [%])12/22 (55)0/14 (0)***
PGIC for sleep (n/total n [%])8/22 (36)0/14 (0)*
Treatment success (n/total n [%])13/22 (59)1/14 (7)**
mBPI-DPN
 PSI7.1 ± 1.56.3 ± 1.84.0 ± 2.86.5 ± 2.1***
 PII6.0 ± 1.95.3 ± 2.03.5 ± 2.65.5 ± 1.5**
NPS
 Deep pain8.2 ± 1.57.6 ± 1.56.3 ± 2.97.4 ± 1.8
 Surface pain6.0 ± 3.36.5 ± 2.43.6 ± 3.46.4 ± 2.1**
 Intensity8.0 ± 1.57.6 ± 1.54.3 ± 3.07.3 ± 2.0***
 Unpleasantness7.9 ± 1.87.6 ± 1.75.4 ± 2.87.5 ± 1.6**
 Coldness4.2 ± 3.64.9 ± 4.02.2 ± 2.75.6 ± 3.1*
 Hotness6.9 ± 2.76.7 ± 3.52.9 ± 3.36.3 ± 2.5**
 Dullness7.6 ± 2.17.7 ± 2.44.6 ± 3.57.6 ± 1.7***
 Sharpness7.9 ± 1.97.3 ± 2.45.0 ± 3.37.7 ± 1.7**
 Sensitivity7.6 ± 2.56.5 ± 2.45.0 ± 3.47.1 ± 2.2*
 Itching3.9 ± 3.13.6 ± 3.31.6 ± 2.64.2 ± 3.2*
EQ-5D§
 Utility scores0.25 ± 0.310.33 ± 0.320.50 ± 0.330.33 ± 0.29
 Current health53.9 ± 18.554.6 ± 16.757.6 ± 24.356.5 ± 14.2
MOS SF-36
 MCS44.7 ± 13.545.3 ± 11.849.3 ± 11.546.7 ± 12.0
 PCS27.9 ± 7.531.7 ± 7.932.3 ± 10.530.5 ± 7.4
MOS-SS
 SPI-956.1 ± 15.653.0 ± 17.240.3 ± 19.652.9 ± 16.5
 Quantity of sleep (h)5.1 ± 1.96.1 ± 2.46.6 ± 1.85.4 ± 2.4
 Optimal sleep (n [%])6 (27)0 (0)5/22 (23)3/14 (21)
BDI#13.2 ± 7.313.7 ± 6.413.0 ± 9.814.4 ± 6.3
  • Plus-minus values are means ± SD.

  • †The modified Brief Pain Inventory- Diabetic Peripheral Neuropathy (mBPI-DPN) assesses the severity of pain and its impact on daily functioning and forms two composite scores: the PSI and the PII. Zero means “no pain’” or “does not interfere” and 10 “pain as bad as you can imagine” or “completely interferes.”

  • ‡The Neuropathic Pain Scale (NPS) includes two items that assess the global dimensions of pain intensity and unpleasantness and eight items that assess the specific qualities of neuropathic pain, in which 0 is “no pain or not” and 10 is “the most sensation imaginable.”

  • §EQ-5D is a health status measure with respect to mobility, self-care, usual activities, pain or discomfort, and anxiety or depression (no problems, some problems, and extreme problems). A utility score of 1 represents “perfect health,” 0 represents “death,” and <0 “worse than death.” Self-rated current health status was assessed using a vertical, visual analog scale on which 0 indicates worst possible health and 100 indicates perfect health.

  • ‖MOS SF-36 measures PCS and MCS and is converted to a 0–100 scale, with higher scores indicating higher levels of functioning or well-being.

  • ¶The Medical Outcomes Study Sleep Scale (MOS-SS) measures sleep quality and quantity. Sleep Problems summary 9 (SPI-9) scores range from 0 to 100 and higher scores indicate worse outcomes.

  • #Severity of depression was measured by the BDI, and higher total scores indicate more severe depressive symptoms.

  • *P < 0.05 for the between-group difference in the ITT analysis.

  • **P < 0.01 for the between-group difference in the ITT analysis.

  • ***P < 0.001 for the between-group difference in the ITT analysis.