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Table 5 Outcomes

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)

Outcome

Variables

Reference

Pain

 Pain assessment (VAS)

0–10 cm

[57]

 Responder rates

Percentage of subjects with ≥50% pain relief compared to baseline

NA

 Remitter rates

Percentage of subjects with ≤3.0 cm pain VAS for at least 6 months

[58]

 Douleur Neuropathique 4 (DN4)

0–10

[59]

 Modified Neuropathy Symptom Score (NSS)

0–9

[60]

 Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN)

Pain severity: 0–10

[61]

Pain-related interference: 0–10

 Short-Form McGill Pain Questionnaire (SF-MPQ-2)

Continuous pain: 0–10

[62]

Intermittent pain: 0–10

Neuropathic pain: 0–10

Affective descriptors: 0–10

Total: 0–10

Health-related quality of life

 Diabetes Quality of Life (DQOL)

Impact: 1–5

[63]

Satisfaction: 1–5

Diabetes worry: 1–5

Social worry: 1–5

Total: 1–5

 EuroQol Five Dimensions Questionnaire (EQ-5D-5L)

Index value (US): −0.109-1.0

[64]

Health VAS: 0–100

 Global Assessment of Functioning (GAF)

0–100

DSM-IV

 Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC)

No change, almost the same, a little bit better, somewhat better, moderately better, or a great deal better

NA

 Sleep (PSQ-3)

0–10 cm

[65]

 Subject satisfaction

Very dissatisfied, dissatisfied, not sure, satisfied, or very satisfied

NA

Medications – Analgesics and Diabetic Control

 Medication usage

Increased, no change, decreased, eliminated

NA

 Dosage

Average dose over time

NA

Function and Health

 Six-minute walk test

Total meters walked

[66]

Shortness of breath: 0–10

Fatigue: 0–10

 Body mass index

Underweight: <18.5 kg/m2

CDC

Normal: 18.5–24.9 kg/m2

Overweight: 25.0–29.9 kg/m2; obese: >30.0 kg/m2

  Hemoglobin A1c (HbA1c)

Normal: 4.0%–5.6%

ADA

Prediabetes: 5.7%–6.4%

Diabetes: ≥6.5%

 Wound healing, including ulcer surveillance

Change in greatest diameter over time

NA

 Health-care utilization

Type, reason, and tests/treatments received during physician, emergency department, and hospital visits

NA

 Work status

Current employment and reason for not working, if applicable

NA

Safety

 Neurological assessments: lower limb motor function, L1–S1 sensation to light touch, pinprick and Semmes–Weinstein 10-g monofilament sensory testing of the feet, patellar and Achilles reflexes, Babinski response

Clinically meaningful deficit, no change, or clinically meaningful improvement in motor, sensory, and reflexes, compared with baseline

NA

Adverse events

Grade I-IV

NA

  1. Abbreviations: ADA American Diabetes Association, CDC Centers for Disease Control and Prevention, DSM-IV Diagnostic and Statistical Manual of Mental Disorders - 4th edition, NA not applicable, VAS visual analog scale