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Table 1 Prior randomized controlled trial data for painful diabetic neuropathy

From: High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN)

Treatment

Number

Average baseline pain

Average pain post-treatment

Responder rate

Length of follow-up

Reference

Pregabalin

76

6.5

4.0

40%

8 wks

[14]

82

6.2

3.6

48%

5 wks

[15]

82

6.7

4.3

39%

6 wks

[16]

82

6.3

3.5

49%

13 wks

[17]

101

6.7

3.7

46%

12 wks

[18]

134

6.9

4.3

38%

12 wks

[19]

66

6.5

4.8

21%

13 wks

[20]

96

NR

NR

47%

16 wks

[21]

123

7.1

2.0

NR

12 wks

[22]

Duloxetine

113

5.9

2.7

52%

12 wks

[23]

116

5.5

3.0

50%

12 wks

[24]

112

6.2

3.4

53%

12 wks

[25]

106

5.5

2.8

57%

12 wks

[26]

32

NR

NR

59%

8 wks

[27]

138

7.1

4.0

42%

12 wks

[19]

57

6.6

3.8

NR

8 wks

[28]

67

NR

NR

28%

16 wks

[21]

Tapentadol

199

NR

NR

38%

15 wks

[29]

12

6.5

3.9

NR

4 wks

[30]

168

7.3

4.4

40%

15 wks

[31]

Low-frequency SCS

40

7.3

3.1

60%

6 mos

[32]

22

7.3

4.0

47%

24 mos

[33]

  1. Prior randomized controlled trial data for treatment of painful diabetic neuropathy with reported average pain scores (visual analog scale or numerical rating scale) and responder rates (reduction in pain of at least 50%). Abbreviations: mos months, NR not reported, SCS spinal cord stimulation, wks weeks