Tapentadol extended release for the management of chronic neck pain

Figures & data

Table 1 Demographic data at baseline (week 0)

	Mean/n	SD/%
Age (years), mean and SD	56.4	12.1
Age-group, n and %
<65 years	42	77.8
≥65 years	12	22.2
Sex, n and %
Male	19	35.2
Female	35	64.8
Body weight (kg), mean and SD	72.6	13.8
BMI (kg/m^2), mean and SD	26.1	4.3
Neck disease, n and %
Spondyloarthrosis	34	63
Cervical stenosis	6	11.1
Discal herniation	18	33.3
Failed surgery	2	3.7
Spondylodiscitis	0
Other	3	5.6
Duration of pain, n and %
3–6 months	26	48.1
>6 months	21	38.9
Missing	7	13
DN4, n and %
<4	14	25.9
≥4	40	74.1
Previous treatment, n and %
Pharmacotherapy	35	64.8
Surgery	2	3.7
Physiotherapy	18	33.3

Abbreviations: SD, standard deviation; BMI, body mass index; DN, neuropathic pain.

Figure 1 Mean and SD pain intensity (11-point NRS) over time (observed-case analysis) at rest and on movement.

Abbreviations: SD, standard deviation; NRS, numeric rating scale.

Figure 2 Percentage of patients with neuropathic pain 4 score ≥4 from baseline to week 12 (final evaluation).

Figure 3 Neck Disability Index (NDI; mean and SD) from baseline to week 12 (final evaluation).

Notes: 55.6% (SD 18.6) at baseline; 44.4% (SD 24.1) at week 1; 38.2% (SD 25.9) at week 2; 31.1% (SD 25.2) at week 4; 25.1% (SD 23.2) at week 8; 19.7% (SD 20.9) at week 12.
Abbreviation: SD, standard deviation.

Figure 4 Percentage of neck ROM variation from baseline to week 12 (final evaluation).

Abbreviation: ROM, range of motion.

Figure 5 SF-36 physical and mental health and total score from baseline to week 12 (final evaluation).

Note: **P<0.01 baseline–final improvement, paired t-test.
Abbreviation: SF-36, Short Form (36) Health Survey.

Figure 6 SF-36 scores from baseline to week 12 (final evaluation).

Note: **P<0.01 baseline–final improvement, paired t-test.
Abbreviation: SF-36, Short Form (36) Health Survey.

Table 2 Neck ROM at weeks 0 and 12

Neck ROM (normal values)	Week 0		Week 12		Pre/postvariation	P-value
	Mean (SD)	%	Mean (SD)	%	%
Flexion (0°–45°)	31.9 (10)	70.9	37.9 (9.3)	84.2	13.3	<0.01
Extension (0°–45°)	24.8 (11)	55.1	37 (9.4)	82.2	27.1	<0.01
Right lateral flexion (0°–45°)	20.4 (9.7)	45.3	36 (6.7)	80	34.7	<0.01
Left lateral flexion (0°–45°)	19.9 (9.2)	44.2	35.8 (6.7)	79.6	35.5	<0.01
Right rotation (0°–80°)	44.7 (17.8)	55.9	64.1 (11.1)	80.1	24.3	<0.01
Left rotation (0°–80°)	46.3 (17.3)	57.9	64.5 (10.5)	80.6	22.7	<0.01

Abbreviations: ROM, range of motion; SD, standard deviation.

Table 3 Opioid-related symptoms at various time points

Opioid-related symptoms, n (%)	Week 0	Week 1	Week 2	Week 4	Week 8	Week 12
Patients, n	54	53	51	48	45	44
Nausea, n (%)	2 (3.7)	4 (7.5)	4 (7.8)	1 (2.1)	0	0
Vomiting, n (%)	0	2 (3.8)	1 (2)	0	0	0
Constipation, n (%)	3 (5.6)	3 (5.7)	3 (5.9)	3 (6.2)	4 (8.9)	4 (9.1)
Dry mouth, n (%)	0	0	0	0	0	0
Dizziness, n (%)	1 (1.8)	5 (9.4)	7 (13.7)	2 (4.2)	3 (6.7)	1 (2.3)
Drowsiness, n (%)	0	4 (7.5)	4 (7.8)	1 (2.1)	1 (2.2)	0
Headache, n (%)	0	0	1 (2)	0	0	0
Sweating, n (%)	0	0	0	0	0	0
Other symptoms, n (%)	0	0	0	0	0	0

Table 4 Frequency of use (%) of other drugs at various time points

Drugs, n (%)	Week 0	Week 1	Week 2	Week 4	Week 8	Week 12
Patients, n	54	53	51	48	45	44
NSAIDs, n (%)	12 (22.2)	1 (1.9)	1 (2)	0	0	0
APAP, n (%)	11 (20.4)	3 (5.7)	2 (3.9)	3 (6.2)	3 (6.7)	2 (4.5)
Antidepressants, n (%)	3 (5.6)	4 (7.5)	3 (5.9)	3 (6.2)	3 (6.7)	3 (6.8)
Anticonvulsants, n (%)	7 (13)	6 (11.3)	6 (11.8)	5 (10.4)	5 (11.1)	5 (11.4)
Corticosteroids, n (%)	3 (5.6)	1 (1.9)	0	0	0	0
Topical drugs, n (%)	2 (3.7)	2 (3.8)	2 (3.9)	3 (6.2)	3 (6.7)	3 (6.8)
Step II opioids, n (%)	6 (11.1)	0	0	0	0	0
Antiemetics, n (%)	0	3 (5.7)	2 (3.9)	0	1 (2.2)	0
Laxatives, n (%)	1 (1.8)	1 (1.9)	1 (2)	3 (6.2)	3 (6.7)	3 (6.8)

Abbreviations: NSAIDs, nonsteroidal anti-inflammatory drugs; APAP, acetaminophen.