Table 1 Baseline demographic and clinical characteristics of both groups.
Characteristics
|
Duloxetine group (n=37)
|
NSAIDs group (n=37)
|
F
|
P-value
|
Age (years), mean (SD)
|
57.16 (6.10)
|
57.81 (6.32)
|
|
0.66
|
Gender, M/F
|
22/15
|
19/18
|
0.64
|
0.32
|
Duration of symptoms (days), mean (SD)
|
53.97 (17.31)
|
54.27 (17.01)
|
|
0.94
|
Affected shoulder, n (%)
|
|
|
1.00
|
0.50
|
Dominant
|
25 (67.57%)
|
26 (70.27%)
|
|
|
Non-dominant
|
12 (32.43%)
|
11 (29.73%)
|
|
|
Baseline pain in activity (VAS 0-10) , mean (SD)
|
7.41 (0.69)
|
7.46 (0.69)
|
|
0.76
|
Notes: Data are given as mean (SD) or ratio.
Abbreviations: NSAIDs, nonsteroidal anti-inflammatory drugs; M, male; F, female; VAS, visual analog scale.
Table 2 The comparison of baseline clinical parameters of the groups.
Clinical parameters
|
Duloxetine group (n=37)
|
NSAIDs group (n=37)
|
P-value
|
VAS (0-10, activity)
|
7.41 ±0.69
|
7.46 ±0.69
|
0.76
|
ROM (degrees)
|
|
|
|
Flexion
|
123.27± 15.20
|
122.41 ± 14.88
|
0.81
|
Abduction
|
68.81 ± 9.49
|
68.19 ± 9.14
|
0.78
|
External rotation
|
64.30 ± 7.76
|
63.70 ± 7.37
|
0.74
|
SPADI scores
|
|
|
|
Pain scale
|
36.68 ± 3.64
|
36.59 ±3.66
|
0.92
|
Disability
|
59.38 ± 5.60
|
59.24 ± 5.64
|
0.92
|
Total
|
96.05 ± 9.05
|
95.84 ± 9.12
|
0.92
|
MPQSF scores
|
|
|
|
Sensory
|
22.41 ± 3.48
|
22.54 ± 3.56
|
0.87
|
Affective
|
7.05 ± 1.87
|
7.30 ± 1.78
|
0.57
|
PRI-total
|
29.46 ± 5.23
|
29.84 ± 5.01
|
0.75
|
VAS
|
7.41 ± 0.69
|
7.46 ± 0.69
|
0.76
|
PPI
|
3.62 ± 0.72
|
3.81 ± 0.78
|
0.28
|
Notes: The Mann-Whitney U test was used to compare the baseline clinical parameters of both groups. No significant differences between both groups with respect to baseline clinical parameters (all P> 0.05).Data are expressed as mean ± SD.
Abbreviations: VAS, visual analog scale; ROM, range of motion; SPADI, Shoulder Pain and Disability Index; MPQSF, McGill Pain Questionnaire Short Form; NSAIDs, nonsteroidal anti-inflammatory drugs.
Table 3 Comparison of change in outcome measures from baseline to end of treatment.
Change in outcome
|
Duloxetine group (n=37)
|
NSAIDs group (n=37)
|
P-value
|
DVAS (activity)
|
5.66 ± 1.02
|
4.80 ± 1.07
|
0.001
|
DROM (degrees)
|
|
|
|
Flexion
|
29.24 ± 12.28
|
25.19 ± 13.67
|
0.184
|
Abduction
|
53.89 ± 10.53
|
46.27 ± 12.31
|
0.006
|
External rotation
|
10.54 ± 4.27
|
7.84 ± 3.86
|
0.006
|
DSPADI scores
|
|
|
|
Pain scale
|
28.49 ± 5.18
|
24.97 ± 5.04
|
0.004
|
Disability
|
50.35 ± 5.54
|
46.43 ± 6.52
|
0.007
|
Total
|
79.11 ± 9.77
|
70.86 ± 9.80
|
0.001
|
DMPQSF scores
|
|
|
|
Sensory
|
19.24 ± 3.39
|
14.70 ± 3.08
|
< 0.001
|
Affective
|
5.92 ± 1.93
|
4.19 ± 1.45
|
< 0.001
|
PRI-total
|
25.27 ± 5.03
|
18.86 ± 3.99
|
< 0.001
|
VAS
|
5.66 ± 1.02
|
4.80 ± 1.07
|
0.001
|
PPI
|
2.65 ± 0.86
|
2.24 ± 0.68
|
0.028
|
Notes: When comparing the change in outcome measures between groups, the improvements in duloxetine group were found to be statistically higher in patients receiving NSAIDs at the end of treatments, only ROM of flexion improvement was not statistically significant compared to NSAIDs group (P=0.184). Data are expressed as mean ± SD.
Abbreviations: VAS, visual analog scale; ROM, range of motion; SPADI, Shoulder Pain and Disability Index; MPQSF, McGill Pain Questionnaire Short Form; NSAIDs, nonsteroidal anti-inflammatory drugs.
Table 4 Summary of treatments effects in both groups during the entire follow-up period.
|
Duloxetine group (n=37)
|
NSAIDs group (n=37)
|
|
Baseline
|
One-month follow-up
|
Three-months follow-up
|
Baseline
|
One-month follow-up
|
Three-months follow-up
|
VAS (0-10, activity)
|
7.41 ±0.69
|
0.99 ± 1.03 a
|
0.36 ± 0.93 b
|
7.46 ± 0.69
|
1.82 ± 1.37 c
|
1.34 ±1.39 d
|
ROM (degrees)
|
|
|
|
|
|
|
Flexion
|
123.27 ± 15.20
|
161.08 ± 10.95 a
|
162.68 ± 10.62 b
|
122.41 ± 14.88
|
158.76 ± 12.18 c
|
160.54 ± 11.92 d
|
Abduction
|
68.81 ± 9.49
|
142.78 ± 15.92 a
|
152.86 ± 14.94 b
|
68.19 ± 9.14
|
137.65 ± 22.92 c
|
149.11 ± 25.52 d
|
External rotation
|
64.30 ± 7.76
|
81.19 ± 6.72 a
|
83.14 ± 5.76 b
|
63.70 ± 7.37
|
79.76 ± 6.53 c
|
81.70 ± 5.92 d
|
SPADI scores
|
|
|
|
|
|
|
Pain scale
|
36.68 ± 3.64
|
6.29 ± 3.42 a
|
5.57 ± 3.09 b
|
36.59 ± 3.66
|
9.67 ± 5.42 c
|
8.52 ± 4.39 d
|
Disability
|
59.38 ± 5.60
|
8.18 ± 2.41 a
|
7.25 ± 2.62 b
|
59.24 ± 5.64
|
10.65 ± 5.87 c
|
9.13 ± 4.76 d
|
Total
|
96.05 ± 9.05
|
14.47 ± 5.62 a
|
12.82 ± 5.49 b
|
95.84 ± 9.12
|
20.32 ± 11.11 c
|
17.65 ± 8.97 d
|
MPQSF scores
|
|
|
|
|
|
|
Sensory
|
22.41 ± 3.48
|
2.65 ± 1.58 a
|
1.87 ± 0.92 b
|
22.54 ± 3.56
|
5.78 ± 2.16 c
|
4.62 ± 2.52 d
|
Affective
|
7.05 ± 1.87
|
1.04 ± 0.82 a
|
0.76 ± 0.45 b
|
7.30 ± 1.78
|
2.65 ± 1.52 c
|
1.57 ±1.49 d
|
PRI-total
|
29.46 ± 5.23
|
3.69 ± 2.32 a
|
2.63 ± 1.23 b
|
29.84 ±5.01
|
8.43 ± 5.45 c
|
6.19 ± 3.87 d
|
VAS
|
7.41 ±0.69
|
0.99 ± 1.03 a
|
0.36 ± 0.93 b
|
7.46 ± 0.69
|
1.82 ± 1.37 c
|
1.34 ±1.39 d
|
PPI
|
3.62 ± 0.72
|
0.82 ± 0.65 a
|
0.61 ± 0.48 b
|
3.81 ± 0.78
|
1.45 ± 0.83 c
|
1.21 ± 0.64 d
|
Notes: The Wilcoxon test was used to investigate the intra-groupdifferences.The SPADI consists two scales including shoulder pain (five items) and disability (eight items). Higher SPADI scores indicated higher degree of shoulder pain and disability.The MPQSF comprises five domains including sensory, affective, PRI-Total, VAS, and PPI. Responses are summed and then transformed onto a scale for each domain. Lower scores in each domain indicate improved health status. Data are expressed as mean ± SD.
a: One-month follow-up vs. baseline in duloxetine group. P< 0.001.
b: Three-months follow-up vs. baseline in duloxetine group. P< 0.001.
c: One-month follow-up vs. baseline in NSAIDs group. P< 0.001.
d: Three-months follow-up vs. baseline in NSAIDs group. P< 0.001.
Abbreviations: VAS, visual analog scale; ROM, range of motion; SPADI, Shoulder Pain and Disability Index; MPQSF, McGill Pain Questionnaire Short Form; NSAIDs, nonsteroidal anti-inflammatory drugs.
Table 5 Summary of side effects.
Side effects
|
Duloxetine (N= 37), n (%)
|
NSAIDs (N= 37), n (%)
|
P-value
|
Patients with ≥ 1 side effect
|
6 (16.22)
|
4 (10.81)
|
0.496
|
Nausea
|
4 (10.81)
|
3 (8.11)
|
0.691
|
Decreased appetite
|
3 (8.11)
|
1 (2.70)
|
0.304
|
Dizziness
|
2 (5.41)
|
0
|
0.152
|
Somnolence
|
1 (2.70)
|
1 (2.70)
|
1
|
Constipation
|
1 (2.70)
|
0
|
0.314
|
Others
|
0
|
0
|
-
|
Notes: Data are presented as the number (percentage) of patients. Data were analyzed using chi square test and fisher’s exact.
Abbreviation: NSAIDs, nonsteroidal anti-inflammatory drugs.