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 |