Table 1:
Participant demographic information divided by study medication administration order.
| Placebo during first session (n=17) | Lidocaine during first session (n=17) | Total (n=34) | |
|---|---|---|---|
|
| |||
| Age, mean (SD) | 57.5 (11.9) | 55.6 (9.8) | 56.6 (10.8) |
|
| |||
| Sex, F/M (% female) | 9/8 (53) | 7/10 (41) | 16/18 (47) |
|
| |||
| Race | |||
| Black (%) | 3 (18) | 7 (41) | 10 (29) |
| White (%) | 14 (82) | 10 (59) | 24 (71) |
|
| |||
| Cumulative years with diabetes diagnosis, median (IQR) | 9 (5-17) | 10 (6-18) | 10 (5-17.5) |
|
| |||
| Hemoglobin A1c, mean (SD) | 8.9 (1.9) | 8.0 (2.0) | 8.4 (2.0) |
|
| |||
| Medical comorbidities (%) | |||
| Hypertension | 13 (76) | 12 (71) | 25 (74) |
| Hypercholesterolemia | 10 (59) | 8 (47) | 18 (53) |
| Cardiovascular disease | 6 (35) | 1 (6) | 7 (21) |
| Sleep apnea | 4 (24) | 1 (6) | 5 (15) |
| Asthma | 1 (6) | 2 (12) | 3 (9) |
| Arthritis | 2 (12) | 1 (6) | 3 (9) |
| Anxiety | 2 (12) | 0 (0) | 2 (6) |
| Depressive disorder | 3 (18) | 3 (18) | 6 (18) |
| History of cancer | 3 (18) | 1 (6) | 4 (12) |
|
| |||
| BMI in kg/m2, median (IQR) | 36.9 (29.9-39.2) | 33.0 (26.0-40.8) | 33.4 (28.4-39.7) |
|
| |||
| Baseline analgesic use (%) | |||
| Any analgesic use | 12 (71) | 10 (59) | 22 (65) |
| Strong opioids (e.g. oxycodone, hydrocodone) | 3 (18) | 1 (6) | 4 (12) |
| Weak opioids (e.g. tramadol, codeine) | 0 (0) | 3 (18) | 3 (9) |
| Non-steroidal anti-inflammatory drugs and/or acetaminophen | 8 (47) | 5 (29) | 13 (38) |
| Serotonin-norepinephrine reuptake inhibitors (e.g. duloxetine, venlafaxine) | 5 (29) | 1 (6) | 6 (18) |
| Tricyclic antidepressants (e.g. amitriptyline) | 2 (12) | 0 (0) | 2 (6) |
| Anticonvulsants (e.g. gabapentin) | 9 (53) | 8 (47) | 17 (50) |
| Topical agents (e.g. lidocaine patch, topical steroids) | 1 (6) | 1 (6) | 2 (6) |
| Antispasmodics (cyclobenzaprine) | 0 (0) | 2 (12) | 2 (6) |
|
| |||
| Duration of painful symptoms prior to study (%) | |||
| Six months up to one year | 3 (18) | 2 (12) | 5 (15) |
| More than one year up to two years | 4 (24) | 0 (0) | 4 (12) |
| More than two years up to five years | 5 (29) | 6 (35) | 11 (32) |
| Greater than five years | 5 (29) | 9 (53) | 14 (41) |
|
| |||
| Pain frequency (%) | |||
| Constant | 17 (100) | 15 (88) | 32 (94) |
| Constant with intermittent exacerbations | 0 (0) | 1 (6) | 1 (3) |
| Intermittent | 0 (0) | 1 (6) | 1 (3) |
|
| |||
| Average pain intensity over the previous week 0-10 NRS, median (IQR) | 6 (5-8) | 6.5 (5.5-7) | 6.2 (5-7.2) |
|
| |||
| Neuropathic Pain Symptom Inventory (NPSI) score, mean (SD) | |||
| Burning | 5.3 (2.4) | 5.5 (2.5) | 5.4 (2.4) |
| Pressing | 4.5 (1.9) | 4.3 (2.7) | 4.4 (2.3) |
| Paroxysmal | 5.1 (2.5) | 4.6 (3.1) | 4.9 (2.8) |
| Evoked | 4.7 (2.2) | 4.3 (2.6) | 4.5 (2.4) |
| Paresthesia/dysesthesia | 6.2 (2.8) | 6.1 (3.2) | 6.2 (2.9) |
| Total | 51 (15.6) | 48.4 (19.5) | 49.7 (17.4) |
|
| |||
| Brief Pain Inventory (BPI), mean (SD) | |||
| Pain severity score | 5.7 (1.4) | 5.6 (2.2) | 5.6 (1.8) |
| Pain interference score | 5.3 (1.8) | 5.7 (2.8) | 5.5 (2.3) |
|
| |||
| Hospital Anxiety and Depression Scale (HADS), mean (SD) | |||
| Depression | 5.8 (3.5) | 6.2 (4.6) | 6 (4) |
| Anxiety | 5.8 (3.8) | 7.4 (4) | 6.6 (4) |