Introduction
Methods
Subjects
Study assessments
Registration, protocol approvals, and subject consents
Statistical analysis
Results
Sociodemographic and clinical characteristics by baseline pain status
Total (N = 1,037) | No/mild pain (n = 304) | Moderate/severe pain (n = 733) |
p value | |
---|---|---|---|---|
Age (years) | ||||
Mean ± SD | 58.0 ± 14.7 | 60.9 ± 14.5 | 56.8 ± 14.7 | <0.0001 |
Data not available | 0 | 0 | 0 | |
Gender | ||||
Female | 772 (74.4) | 226 (74.3) | 546 (74.5) | 0.9608 |
Data not available | 0 | 0 | 0 | |
Race/ethnicity | ||||
White | 959 (92.5) | 285 (93.8) | 674 (92.0) | 0.2832 |
Non-Whitea
| 78 (7.5) | 19 (6.3) | 59 (8.0) | |
Data not available | 0 | 0 | 0 | |
BMI (kg/m2) | ||||
Mean ± SD | 26.6 ± 5.4 | 26.4 ± 5.2 | 26.7 ± 5.5 | 0.3531 |
Data not available | 74 | 24 | 50 | |
Educational level | ||||
Less than a high school diploma | 41 (4.0) | 9 (3.0) | 32 (4.4) | 0.0005 |
High school graduate/some college | 518 (50.0) | 130 (42.8) | 388 (52.9) | |
Associate/Bachelor’s degree | 314 (30.3) | 112 (36.8) | 202 (27.6) | |
Advanced degree (Masters, Doctoral, Professional) | 147 (14.2) | 50 (16.4) | 97 (13.2) | |
Other | 17 (1.6) | 3 (1.0) | 14 (1.9) | |
Data not available | 0 | 0 | 0 | |
Employment status | ||||
Retired | 339 (32.7) | 116 (38.2) | 223 (30.4) | <0.0001 |
Employed full time | 308 (29.7) | 99 (32.6) | 209 (28.5) | |
Employed part time | 67 (6.5) | 28 (9.2) | 39 (5.3) | |
Disabled | 123 (11.9) | 15 (4.9) | 108 (14.7) | |
Self-employed | 61 (5.9) | 19 (6.2) | 42 (5.7) | |
Otherb
| 139 (13.4) | 27 (8.9) | 112 (15.3) | |
Data not available | 0 | 0 | 0 | |
Work stopped due to CDc, n (%) | 107 (38.5) | 15 (20.5) | 92 (44.9) | 0.0002 |
Employment status affected by CDd
| ||||
No | 327 (74.0) | 134 (89.3) | 193 (66.1) | <0.0001 |
Yes | ||||
Different job with less responsibility/pay | 28 (6.3) | 5 (3.3) | 23 (7.9) | |
Loss of employment | 4 (0.9) | 0 (0.0) | 4 (1.4) | |
Reduced hours or responsibility | 83 (18.8) | 11 (7.3) | 72 (24.7) | |
Severity | ||||
Mild | 344 (33.2) | 111 (36.5) | 233 (31.8) | 0.0376 |
Moderate | 546 (52.7) | 161 (53.0) | 385 (52.6) | |
Severe | 146 (14.1) | 32 (10.5) | 114 (15.6) | |
Data not available | 1 | 0 | 1 | |
CD type | ||||
Anterocollis | 59 (5.7) | 13 (4.3) | 46 (6.3) | 0.0150 |
Laterocollis | 402 (38.8) | 103 (33.9) | 299 (40.8) | |
Retrocollis | 55 (5.3) | 12 (3.9) | 43 (5.9) | |
Torticollis | 493 (47.6) | 164 (53.9) | 329 (44.9) | |
Other | 27 (2.6) | 12 (3.9) | 15 (2.0) | |
Data not available | 1 | 0 | 1 | |
Age at symptom onset, years | ||||
Mean ± SD | 49.0 ± 16.7 | 50.1 ± 17.4 | 48.6 ± 16.4 | 0.1879 |
Data not available | 0 | 0 | 0 | |
Time from CD onset to diagnosis (years) | ||||
Mean ± SD | 5.0 ± 8.1 | 5.6 ± 7.1 | 4.7 ± 8.5 | 0.0704 |
Data not available | 0 | 0 | 0 | |
Time from CD diagnosis to treatment (years) | ||||
Mean ± SD | 1.2 ± 4.5 | 1.6 ± 6.0 | 1.0 ± 3.7 | 0.0840 |
Data not available | 0 | 0 | 0 | |
Previously received BoNT treatment | ||||
n (%) | 378 (36.5) | 107 (35.2) | 271 (37.0) | 0.5890 |
Data not available | 0 | 0 | 0 | |
Concomitant medicationse
| ||||
Vitamins and combinations | 373 (36.0) | 108 (35.5) | 265 (36.2) | 0.8482 |
Analgesics, miscellaneous | 230 (22.2) | 34 (11.2) | 196 (26.7) | <0.0001 |
Antilipidemic agents, HMG-CoA reductase inhibitors | 168 (16.2) | 68 (22.4) | 100 (13.6) | 0.0005 |
Antidepressants, selective serotonin reuptake inhibitors | 162 (15.6) | 47 (15.5) | 115 (15.7) | 0.9265 |
β-Adrenergic blocking agents | 154 (14.9) | 68 (22.4) | 86 (11.7) | <0.0001 |
Thyroid preparations | 139 (13.4) | 41 (13.5) | 98 (13.4) | 0.9598 |
Antianxiety agents, benzodiazepines and combinations | 131 (12.6) | 28 (9.2) | 103 (14.1) | 0.0327 |
Antidepressants, miscellaneous | 123 (11.9) | 21 (6.9) | 102 (13.9) | 0.0015 |
Proton pump inhibitors | 119 (11.5) | 43 (14.1) | 76 (10.4) | 0.0824 |
Data not available | 0 | 0 | 0 |
Odds ratio | 95 % CI |
p value | |
---|---|---|---|
Employment status | |||
Employed part time | |||
Moderate/severe pain | 0.7 | 0.4–1.3 | 0.2881 |
Male | 0.3 | 0.1–0.7 | 0.0060 |
Self-employed | |||
Moderate/severe pain | 1.3 | 0.7–2.3 | 0.4429 |
Male | 1.2 | 0.6–2.2 | 0.6108 |
Retired | |||
Moderate/severe pain | 1.6 | 1.0–2.6 | 0.0533 |
Male | 1.0 | 0.6–1.6 | 0.9333 |
Disabled | |||
Moderate/severe pain | 3.9 | 2.2–7.2 | <0.0001 |
Male | 1.5 | 1.0–2.5 | 0.0799 |
Othera
| |||
Moderate/severe pain | 2.2 | 1.3–3.6 | 0.0028 |
Male | 0.6 | 0.3–1.0 | 0.0328 |
Work stopped due to CDb
| |||
Moderate/severe pain | 2.2 | 1.2–4.5 | 0.0193 |
Male | 1.2 | 0.7–2.2 | 0.4599 |
Employment status affected by CDc
| |||
Moderate/severe pain | 4.5 | 2.6–8.3 | <0.0001 |
Male | 1.1 | 0.6–1.8 | 0.8413 |
Clinical measures of pain
Total (N = 1,036)a
| Mild (n = 344) | Moderate (n = 546) | Severe (n = 146) |
p value | |
---|---|---|---|---|---|
PNRS | |||||
n
| 1,036 | 344 | 546 | 146 | |
Mean ± SD | 5.1 ± 3.0 | 4.7 ± 2.9 | 5.2 ± 3.0 | 5.9 ± 2.9 | 0.0004 |
Data not available | 0 | 0 | 0 | 0 | |
TWSTRS Pain subscale | |||||
n
| 1,034 | 344 | 544 | 146 | |
Mean ± SD | 10.5 ± 5.1 | 10.0 ± 5.2 | 10.5 ± 5.0 | 11.6 ± 5.1 | 0.0058 |
Data not available | 2 | 0 | 2 | 0 | |
CDIP-58 Pain and Discomfort subscale | |||||
n
| 1,027 | 344 | 538 | 145 | |
Mean ± SD | 70.6 ± 22.8 | 69.7 ± 22.5 | 70.2 ± 23.3 | 74.6 ± 21.3 | 0.0545 |
Data not available | 9 | 0 | 8 | 1 |
Total (N = 1,037) | No/mild pain (n = 304) | Moderate/severe pain (n = 733) |
p value | |
---|---|---|---|---|
TWSTRS | ||||
Severity | 17.3 ± 5.3 | 16.2 ± 5.6 | 17.7 ± 5.1 | <0.0001 |
Disability | 11.1 ± 6.4 | 7.5 ± 5.6 | 12.7 ± 6.1 | <0.0001 |
Pain | 10.5 ± 5.1 | 5.1 ± 4.2 | 12.7 ± 3.5 | <0.0001 |
Total | 38.9 ± 13.1 | 28.7 ± 11.3 | 43.1 ± 11.4 | <0.0001 |
Data not available | 3 | 0 | 3 |
Pain and severity relationship with CD impact
OnabotulinumtoxinA treatment utilization
No/mild pain | Moderate/severe pain |
p value | No/mild pain + naïve | Moderate/severe pain + naïve |
p value | No/mild pain + non-naïve | Moderate/severe pain + non-naïve |
p value | |
---|---|---|---|---|---|---|---|---|---|
Total dose, U (N = 973)a
| |||||||||
Subjects, n
| 292 | 681 | 192 | 419 | 100 | 262 | |||
Mean ± SD | 158.0 ± 67.1 | 177.3 ± 82.9 | 0.0001 | 136.6 ± 56.6 | 151.6 ± 64.9 | 0.0216 | 198.9 ± 67.0 | 218.3 ± 91.7 | 0.0216 |
Min, max | 15.0, 400.0 | 15.0, 500.0 | 15.0, 346.0 | 15.0, 407.0 | 45.0, 400.0 | 40.0, 500.0 | |||
Median | 150.0 | 166.0 | 127.5 | 150.0 | 200.0 | 200.0 | |||
Regression-adjusted mean | – | – | 135.5 | 152.1 | 201.0 | 217.5 | |||
Total number of muscles (N = 1,036)b
| |||||||||
Subjects, n
| 303 | 733 | 196 | 462 | 107 | 271 | |||
Mean ± SD | 3.7 ± 1.2 | 4.1 ± 1.4 | <0.0001 | 3.5 ± 1.2 | 4.0 ± 1.3 | <0.0001 | 4.0 ± 1.2 | 4.2 ± 1.4 | 0.7402 |
Min, max | 1.0, 7.0 | 1.0, 11.0 | 1.0, 7.0 | 1.0, 10.0 | 1.0, 7.0 | 1.0, 11.0 | |||
Median | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | |||
Regression-adjusted mean | – | – | 3.6 | 4.0 | 3.9 | 4.2 |
Estimate | 95 % CI |
p value | |
---|---|---|---|
Dose, Ua
| |||
Moderate/severe pain | 13.90 | 3.14, 24.66 | 0.0114 |
Age (years) | −0.48 | −0.81, −0.14 | 0.0051 |
Male | 14.56 | 3.36, 25.75 | 0.0109 |
TWSTRS Severity Score | 2.33 | 1.41, 3.25 | <0.0001 |
Muscles injected, n
b
| |||
Moderate/severe pain | 0.31 | 0.13, 0.49 | 0.0008 |
Age (years) | −0.01 | −0.01, −0.00 | 0.0051 |
Male | −0.25 | −0.44, −0.06 | 0.0089 |
TWSTRS Severity Score | 0.03 | 0.01, 0.04 | 0.0004 |