Table 3.
Variable | Baseline | Missing | Two-year follow-up | Missing | Change | Missing | p value |
---|---|---|---|---|---|---|---|
PN outcomes | |||||||
IENFD distal leg (fibres/mm) | 8.5 ± 6.9 | 2 | 8.6 ± 6.0 | 3 | 0.1 ± 4.1 | 5 | 0.92 |
IENFD thigh (fibres/mm) | 15.0 ± 7.9 | 1 | 18.4 ± 7.5 | 1 | 3.4 ± 7.8 | 2 | <0.01 |
PN (Toronto Consensus Definition of probable neuropathy) | 13 (16.5) | 0 | 21 (27.0) | 0 |
Worsened: 8 (10.1) Stable: 71 (89.9) Improved: 0 (0.0) |
0 | <0.01a |
Nerve conduction study outcomesb | |||||||
Peroneal distal motor latency (ms) | 4.7 ± 0.9 | 0 | 4.7 ± 0.9 | 0 | −0.1 ± 0.8 | 0 | 0.50 |
Peroneal amplitude (μV) | 5.8 ± 2.8 | 0 | 5.3 ± 2.7 | 0 | −0.4 ± 2.3 | 0 | 0.13 |
Peroneal F wave index (ms) | 49.8 ± 6.3 | 1 | 49.9 ± 5.9 | 0 | −0.03 ± 4.2 | 1 | 0.95 |
Peroneal CV (m/s) | 45.5 ± 5.6 | 0 | 44.7 ± 6.2 | 0 | −0.7 ± 5.9 | 0 | 0.30 |
Sural peak latency (ms) | 3.9 ± 0.5 | 1 | 3.8 ± 0.5 | 0 | −0.1 ± 0.5 | 1 | 0.29 |
Sural amplitude (μV) | 10.9 ± 6.8 | 1 | 11.8 ± 6.8 | 0 | 0.7 ± 5.8 | 1 | 0.32 |
Tibial distal motor latency (ms) | 4.7 ± 0.9 | 0 | 5.1 ± 0.9 | 0 | 0.4 ± 1.0 | 0 | <0.01 |
Tibial amplitude (μV) | 8.8 ± 5.5 | 0 | 9.1 ± 5.2 | 0 | 0.4 ± 3.3 | 0 | 0.32 |
Tibial F wave index (ms) | 51.5 ± 6.1 | 0 | 50.5 ± 6.0 | 1 | −0.8 ± 3.7 | 1 | 0.08 |
QSTb | |||||||
QST cold | 10.2 ± 4.2 | 0 | 10.3 ± 3.5 | 0 | 0.2 ± 4.5 | 0 | 0.73 |
QST vibration | 16.1 ± 4.2 | 0 | 17.2 ± 3.3 | 0 | 1.1 ± 2.4 | 0 | <0.01 |
MNSI | |||||||
MNSI questionnaire | 3.1 ± 2.8 | 0 | 2.3 ± 2.5 | 0 | −0.8 ± 1.8 | 0 | <0.01 |
MNSI exam | 1.0 ± 1.4 | 0 | 1.0 ± 1.4 | 0 | −0.01 ± 1.1 | 0 | 0.96 |
MNSI index | 1.3 ± 1.1 | 0 | 1.1 ± 0.9 | 0 | −0.2 ± 0.9 | 0 | 0.03 |
Utah Early Neuropathy Scale (UENS) | 3.2 ± 5.3 | 0 | 3.8 ± 5.9 | 0 | 0.6 ± 3.7 | 0 | 0.08 |
Neurothesiometer testing | 10.5 ± 15.4 | 0 | 13.9 ± 23.6 | 0 | 3.4 ± 11.3 | 0 | 0.01 |
Monofilament test |
Worsened: 5 (6.3) Stable: 68 (86.1) Improved: 6 (7.6) |
0.81a | |||||
Normal | 68 (86.1) | 0 | 71 (89.9) | 0 | 0 | ||
Reduced | 8 (10.1) | 0 | 4 (5.1) | 0 | 0 | ||
Absent | 3 (3.8) | 0 | 4 (5.1) | 0 | 0 | ||
CAN outcomes | 0.89 | ||||||
E/I ratio | 1.2 ± 0.1 | 0 | 1.2 ± 0.1 | 7 | −0.01 ± 0.1 | 7 | |
CAN present (E/I ratio <1.09) | 20 (25.3) | 0 | 14 (17.7) | 7 |
Worsened: 5 (6.9) Stable: 58 (80.6) Improved: 9 (12.5) |
7 | 0.30a |
SAS score | 5.9 ± 5.6 | 1 | 6.2 ± 5.7 | 0 | 0.3 ± 5.3 | 1 | 0.58 |
RFA | 2.1 ± 3.6 | 0 | 6.0 ± 38.3 | 7 | 4.1 ± 38.5 | 7 | 0.37 |
LFA | 2.1 ± 2.5 | 0 | 1.5 ± 4.3 | 7 | −0.6 ± 5.0 | 7 | 0.34 |
LFA/RFA | 242.8 ± 2078.4 | 0 | 289.3 ± 2057.1 | 7 | 28.1 ± 3019.4 | 7 | 0.94 |
sdNN | 43.4 ± 23.4 | 0 | 49.5 ± 30.5 | 7 | 7.5 ± 30.4 | 7 | 0.04 |
pNN50 | 9.0 ± 12.0 | 0 | 14.1 ± 16.6 | 7 | 5.7 ± 14.4 | 7 | <0.01 |
rmsSD | 28.7 ± 21.0 | 0 | 36.4 ± 29.2 | 7 | 9.3 ± 29.3 | 7 | <0.01 |
Median heart rate | 73.2 ± 9.2 | 0 | 63.8 ± 8.7 | 7 | −9.6 ± 8.7 | 7 | <0.01 |
Retinopathy outcomes | |||||||
Mean deviation | −1.2 ± 4.3 | 1 | −1.6 ± 4.2 | 1 | −0.2 ± 3.0 | 2 | 0.52 |
Retinopathy | 4 (5.1) | 1 | 2 (2.5) | 3 |
Worsened: 1 (1.3) Stable: 71 (94.7) Improved: 3 (4.0) |
4 | 0.50a |
Pattern SD | 3.2 ± 1.1 | 1 | 3.1 ± 0.9 | 1 | −0.2 ± 0.9 | 2 | 0.09 |
Foveal sensitivity | 27.2 ± 5.3 | 1 | 27.0 ± 5.0 | 1 | −0.1 ± 4.5 | 2 | 0.91 |
CKD outcomes | |||||||
eGFR (ml/min per 1.73 m2) | 98.0 ± 18.5 | 0 | 94.6 ± 19.8 | 1 | −3.4 ± 10.0 | 1 | <0.01 |
CKD (KDIGO criteria) | 7 (8.9) | 0 | 11 (13.9) | 1 |
Worsened: 5 (6.4) Stable: 72 (92.3) Improved: 1 (1.3) |
1 | 0.13a |
Microalbumin/creatinine ratio (mg/g) | 0.2 ± 0.3 | 0 | 0.2 ± 0.7 | 0 | 0.05 ± 0.7 | 0 | 0.56 |
Patient-oriented outcomes | |||||||
McGill pain scale | |||||||
McGill VAS | 2.8 ± 2.8 | 0 | 1.8 ± 2.4 | 0 | −1.0 ± 2.6 | 0 | <0.01 |
McGill present pain intensity index |
Worsened: 8 (10.1) Stable: 55 (69.6) Improved: 16 (20.3) |
<0.01 | |||||
No pain | 53 (67.1) | 0 | 56 (70.9) | 0 | 0 | ||
Mild | 11 (13.9) | 0 | 12 (15.2) | 0 | 0 | ||
Discomforting | 11 (13.9) | 0 | 9 (11.4) | 0 | 0 | ||
Distressing | 3 (3.8) | 0 | 2 (2.5) | 0 | 0 | ||
Horrible | 1 (1.3) | 0 | 0 (0.0) | 0 | 0 | ||
Excruciating | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 | ||
McGill total | 5.5 ± 6.4 | 0 | 3.5 ± 4.8 | 0 | −2.0 ± 5.5 | 0 | <0.01 |
McGill sensory | 4.7 ± 5.4 | 0 | 3.0 ± 4.0 | 0 | −1.7 ± 4.4 | <0.01 | |
McGill affective | 1.1 ± 2.7 | 0 | 0.5 ± 1.1 | 0 | −0.6 ± 2.7 | 0.06 | |
Neuro-QOL | |||||||
Neuro-QOL total | 2.9 ± 2.0 | 1 | 2.3 ± 1.5 | 1 | −0.6 ± 1.9 | 2 | <0.01 |
Neuro-QOL pain | 2.7 ± 2.0 | 0 | 2.2 ± 1.9 | 0 | −0.5 ± 1.9 | 0 | 0.02 |
Neuro-QOL reduced sensation | 2.0 ± 2.0 | 0 | 1.9 ± 2.2 | 0 | −0.1 ± 1.5 | 0 | 0.49 |
Neuro-QOL sensory motor | 2.7 ± 2.6 | 0 | 2.1 ± 1.9 | 0 | −0.5 ± 2.4 | 0 | 0.05 |
Neuro-QOL social/emotional | 2.9 ± 2.8 | 1 | 2.3 ± 1.9 | 1 | −0.7 ± 2.8 | 2 | 0.02 |
Neuro-QOL activities of daily living | 3.4 ± 2.6 | 1 | 3.2 ± 1.9 | 1 | −0.1 ± 2.7 | 2 | 0.77 |
Neuro-QOL overall QOL | 2.6 ± 1.0 | 0 | 2.1 ± 0.9 | 0 | −0.5 ± 0.9 | 0 | <0.01 |
Neuro-QOL foot-specific QOL | 1.5 ± 1.0 | 0 | 1.2 ± 0.6 | 0 | −0.3 ± 1.0 | 0 | <0.01 |
Impact of Weight on Quality of Life (IWQOL-Lite) | 80.3 ± 24.2 | 5 | 48.7 ± 18.9 | 1 | −31.3 ± 24.1 | 6 | <0.01 |
EuroQOL EQ-5D-3L | |||||||
EQ-5D current health status VAS | 66.6 ± 20.8 | 1 | 79.0 ± 14.9 | 0 | 12.4 ± 20.5 | 1 | <0.01 |
EQ-5D mobility |
Worsened: 4 (5.1) Stable: 59 (74.7) Improved: 16 (20.3) |
0.03a | |||||
I have no problems walking about | 52 (65.8) | 0 | 64 (81.0) | 0 | 0 | ||
I have some problems walking about | 27 (34.2) | 0 | 15 (19.0) | 0 | 0 | ||
I am confined to bed | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 | ||
EQ-5D self-care |
Worsened: 1 (1.3) Stable: 72 (91.1) Improved: 6 (7.6) |
0.08a | |||||
I have no problems with self-care | 72 (91.1) | 0 | 77 (97.5) | 0 | 0 | ||
I have some problems washing or dressing myself | 7 (8.9) | 0 | 2 (2.5) | 0 | 0 | ||
I am unable to wash or dress myself | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 | ||
EQ-5D usual activities |
Worsened: 4 (5.1) Stable: 61 (77.2) Improved: 14 (17.7) |
1.00a | |||||
I have no problems performing my usual activities | 55 (69.6) | 0 | 64 (81.0) | 0 | 0 | ||
I have some problems performing my usual activities | 23 (29.1) | 0 | 15 (19.0) | 0 | 0 | ||
I am unable to perform my usual activities | 1 (1.3) | 0 | 0 (0.0) | 0 | 0 | ||
EQ-5D pain/discomfort |
Worsened: 5 (6.3) Stable: 51 (64.6) Improved: 23 (29.1) |
0.15a | |||||
I have no pain or discomfort | 32 (40.5) | 0 | 46 (58.2) | 0 | 0 | ||
I have moderate pain or discomfort | 41 (51.9) | 0 | 31 (39.2) | 0 | 0 | ||
I have extreme pain or discomfort | 6 (7.6) | 0 | 2 (2.5) | 0 | 0 | ||
EQ-5D anxiety/depression |
Worsened: 12 (15.2) Stable: 60 (75.9) Improved: 7 (8.9) |
0.78a | |||||
I am not anxious or depressed | 53 (67.1) | 0 | 47 (59.5) | 0 | 0 | ||
I am moderately anxious or depressed | 19 (24.1) | 0 | 26 (32.9) | 0 | 0 | ||
I am extremely anxious or depressed | 7 (8.9) | 0 | 6 (7.6) | 0 | 0 | ||
Depressive symptomology (IDS-SR) | 18.5 ± 10.9 | 0 | 15.7 ± 13.0 | 1 | −2.9 ± 10.3 | 1 | 0.01 |
Physical activity level |
Worsened: 16 (20.3) Stable: 31 (39.2) Improved: 32 (40.5) |
0.06a | |||||
No physical activity | 4 (5.1) | 0 | 1 (1.3) | 0 | 0 | ||
Only light physical activity in most weeks | 32 (40.5) | 0 | 31 (39.2) | 0 | 0 | ||
Vigorous physical activity for at least 20 min once or twice per week | 28 (35.4) | 0 | 16 (20.3) | 0 | 0 | ||
Vigorous physical activity for at least 20 min more than twice per week | 15 (19.0) | 0 | 31 (39.2) | 0 | 0 |
p values were calculated using a paired t test except where indicated by a superscript a, in which case they represent the result obtained using Wilcoxon signed-rank test
bSome participants also reported no response for nerve conduction study and QST measurements at baseline (V1) and follow-up (V2). No response was recorded for peroneal distal motor latency (V1: 3, V2: 3), amplitude (V1: 3, V2: 3), CV (V1: 3, V2: 3), and F wave index (V1: 5, V2: 2), sural peak latency (V1: 6, V2: 6), tibial distal motor latency (V1: 2, V2: 2) amplitude (V1: 2, V2: 2), and F wave index (V2: 1), QST cold (V1: 2, V2: 1) and vibration (V2: 1)