Table. Baseline Characteristics for All Randomized Patients.
| Characteristic | No. (%) | Standardized differencea | |
|---|---|---|---|
| CMM (n = 103) | 10-kHz SCS plus CMM (n = 113) | ||
| Age, y | |||
| Mean (SD) | 60.8 (9.9) | 60.7 (11.4) | 0.01 |
| Median (IQR) | 62.0 (55.0-67.5) | 61.0 (55.0-70.0) | |
| Sex | |||
| Male | 66 (64.1) | 70 (61.9) | 0.04 |
| Female | 37 (35.9) | 43 (38.1) | |
| Race | |||
| White | 85 (82.5) | 87 (77.0) | 0.14 |
| Black or African American | 13 (12.6) | 18 (15.9) | |
| Native Hawaiian or other Pacific Islander | 1 (1.0) | 3 (2.7) | |
| American Indian or Alaska Native | 0 | 2 (1.8) | |
| Asian | 1 (1.0) | 1 (0.9) | |
| Other | 3 (2.9) | 2 (1.8) | |
| Diabetes | |||
| Type 1 | 3 (2.9) | 8 (7.1) | 0.19 |
| Type 2 | 100 (97.1) | 105 (92.9) | |
| Duration, y | |||
| Diabetes | |||
| Mean (SD) | 12.2 (8.5) | 12.9 (8.5) | 0.09 |
| Median (IQR) | 10.4 (6.3-15.2) | 12.0 (6.4-18.6) | |
| Peripheral neuropathy | |||
| Mean (SD) | 7.1 (5.1) | 7.4 (5.7) | 0.06 |
| Median (IQR) | 5.4 (2.9-10.0) | 5.7 (3.1-10.1) | |
| Lower limb pain VAS | |||
| Mean (SD), cm | 7.1 (1.6) | 7.5 (1.6) | 0.22 |
| Median (IQR), cm | 7.2 (6.2-8.2) | 7.5 (6.6-8.6) | |
| <7.5 cm | 57 (55.3) | 54 (47.8) | 0.15 |
| ≥7.5 cm | 46 (44.7) | 59 (52.2) | |
| HbA1c | |||
| Mean (SD), % | 7.4 (1.2) | 7.3 (1.1) | 0.11 |
| Median (IQR), % | 7.3 (6.6-8.2) | 7.3 (6.3-8.2) | |
| <7.0% | 40 (38.8) | 46 (40.7) | 0.04 |
| ≥7.0% | 63 (61.2) | 67 (59.3) | |
| BMIb | |||
| Mean (SD) | 33.9 (5.2) | 33.6 (5.4) | 0.06 |
| Median (IQR) | 34.3 (30.9-37.1) | 33.6 (29.8-36.3) | |
| Severity of neuropathic pain | |||
| DN4 | |||
| Mean (SD) | 6.5 (1.9) | 6.6 (1.7) | 0.12 |
| Median (IQR) | 6 (5-8) | 7 (5-8) | |
| <3 | 3 (2.9) | 1 (0.9) | 0.15 |
| ≥3 | 99 (97.1) | 112 (99.1) | |
| mNSS | |||
| Mean (SD) | 6.9 (1.1) | 6.8 (1.3) | 0.05 |
| Median (IQR) | 7 (6-8) | 7 (6-8) | |
| Mild (3-4) | 2 (2.0) | 2 (1.8) | NA |
| Moderate (5-6) | 33 (32.4) | 46 (40.7) | |
| Severe (7-9) | 67 (65.7) | 65 (57.5) | |
| Pain medications | |||
| Anticonvulsants | |||
| Gabapentin | 50 (48.5) | 63 (55.8) | 0.14 |
| Pregabalin | 29 (28.2) | 25 (22.1) | 0.14 |
| Antidepressants | |||
| SNRIs | 29 (28.2) | 25 (22.1) | 0.14 |
| TCAs | 14 (13.6) | 10 (8.8) | 0.15 |
| Opioids | 44 (42.7) | 50 (44.2) | 0.03 |
| Topicals | 9 (8.7) | 11 (9.7) | 0.03 |
| Diabetes medications | |||
| Insulin | 47 (45.6) | 51 (45.1) | 0.01 |
| Oral and noninsulin injectable medications | 84 (81.6) | 88 (77.9) | 0.09 |
Abbreviations: BMI, body mass index; CMM, conventional medical management; DN4, Douleur Neuropathique; HbA1c, hemoglobin A1c; IQR, interquartile range; mNSS, modified Neuropathy Symptom Score; NA, not applicable; SCS, spinal cord stimulation; SNRI, serotonin-norepinephrine reuptake inhibitor; TCA, tricyclic antidepressant; VAS, visual analogue scale.
Possible imbalances in baseline characteristics were evaluated with a standardized difference effect size index (Cohen d). Index scores less than 0.20 suggest the groups are well matched, whereas scores of 0.20 or greater indicate small differences, of 0.50 or greater indicate medium differences, and of 0.80 or greater indicate large differences between the groups.
Calculated as weight in kilograms divided by height in meters squared.