Keywords
orthopedic procedures - pain - neuralgia - lidocaine - massage
Introduction
Chronic postoperative pain, defined as persistent pain at surgical incision sites
for 3 months after the procedure, is a frequent complaint in orthopedic practice.[1] Virtually 50% of patients undergoing orthopedic surgery are affected by this syndrome.
Arthrodesis, knee arthroplasty, and osteosynthesis for leg fractures are the surgeries
with the highest risk of development of chronic postoperative pain. However, any orthopedic
surgery may result in this condition;[2] its treatment constitutes a challenge for the surgeon, since it requires knowledge
on the several pain mechanisms and pharmacological options available. Most patients
end up not receiving adequate treatment and present with chronic pain, which directly
affects the doctor-patient relationship, leading to dissatisfaction, lower adherence
to complementary therapies, and worse clinical outcomes and parameters.
Several pharmacological modalities have been proposed as alternatives for chronic
postoperative pain treatment, including tricyclic antidepressants, selective serotonin
reuptake inhibitors, gabapentin, pregabalin, and opioids.[3] A recently introduced 5% lidocaine patch acts as a mechanical barrier and pharmacologically
inhibits sodium channels. Its use is associated with a medium- to long-term desensitization
of pain receptors. Lidocaine patches are considered a first-line medication in patients
with neuropathic pain or post-herpetic neuralgia (PHN), and it was superior to pregabalin
in these subjects.[3]
[4]
[5]
Nonpharmacological measures have also been successful in the treatment of chronic
scar tissue pain, especially manual massage, performed by the patient using circular
movements over the scar area for 10 minutes, 2 or 3 times a day.[6] A recent literature review reported the positive effect of massage on surgical scars
in 90% of the patients treated for 30 to 180 days.[7] The present study aims to evaluate the use of a lidocaine patch to treat localized
neuropathic pain in scar tissue of patients submitted to orthopedic procedures in
comparison with therapeutic massage over surgical incisions; in addition, the social
impact of the treatment was assessed through satisfaction scales and functional classifications.
Material and methods
This is a prospective, randomized clinical trial with 37 patients who underwent orthopedic
surgery from January 2015 to February 2017 after approval by the Ethics Committee
under the number CAAE 64900217000005488. Patients aged between 13 and 70 years old,
submitted to foot and ankle orthopedic surgeries and presenting with neuropathic pain
or hypersensitivity at the surgical incision site for at least 90 days after the procedure
were included. Patients outside this age range, presenting allergy to lidocaine, skin
conditions and/or lesions, altered bone consolidation (delayed consolidation or pseudarthrosis),
or incision site infection, in addition to those who abandoned outpatient follow-up,
were excluded. Patients were selected and evaluated from April to August 2017. All
individuals were included after signing the informed consent form and then were randomly
allocated into two groups: (a) use of a 5% lidocaine patch (700 mg) for 12 hours per
day; (b) manual massage with circular compression over the entire length of the scar
for 10 minutes, twice a day. The patients were assessed for pain using the visual
analog scale (VAS), the personal satisfaction index (excellent = 1, good = 2, regular = 3,
or poor = 4) and the quality of life questionnaire SF-36 (Appendix 1) in 4 moments: at the beginning of the treatment, and after 30, 60, and 90 days.
There was no loss to follow-up or treatment abandonment. All patients were instructed
to use paracetamol, 750 mg, as a rescue medication; alternatively, the patient could
use dipyrone, 1 g, in case of atopy with paracetamol. The use of analgesic agents
was not considered an exclusion criterion for the study.
The effects of the treatment were analyzed by comparing mean values in each group.
Tests were performed with analysis of variance (ANOVA) models with repeated measures
and group and moment as factors, and/or combining unpaired and paired Student t-tests
or their nonparametric equivalents if the model assumptions were not satisfied. The
significance level was set at 5% when using the statistical model; otherwise, it was
adjusted by the general Bonferroni correction. All statistical analyzes were performed
using the statistical software R 3.4.1 (R Foundation, Vienna, Austria) and NCSS 8.0
(Teikoku Seiyaku Co., Ltd 567 Sanbonmatsu, Higashikagawa, Kagawa – Japão Embalado
por: Grünenthal GmbH Zieglerstraße 6 - Aachen - Alemanha).
The present study was registered at International Standard Randomised Controlled Trial
Number (ISRCTN) under ID ISRCTN59332544.
Results
Pain assessment using the visual analog scale
In total, 148 pain assessments using the VAS were recorded in 37 patients at 4 moments:
pretreatment visit (t0), and visits at 30 (t1), 60 (t2), and 90 (t3) days after treatment.
Pain variations were determined by subtracting the baseline score from the value obtained
at each subsequent visit. An analysis at the t0 visit was carried out to verify whether
Toperma and Massage treatment groups were comparable with each other regarding the
pain measured by the VAS. A Student t-test was performed and found no significant
evidence that the groups had different mean pain scores (p = 0.697).
Both groups reported a reduction in pain over time. This decrease was statistically
relevant at the first visit (p < 0.05). Both groups showed statistically similar results ([Figure 1]). An ANOVA model with repeated measures was used to test differences between groups
and over time. The mean pain variations at each visit were distinct from each other
(p < 0.001), but with no significant difference between treatment groups (p = 0.158); however, there seems to be a trend that each group presents a different
pain reduction pattern from the other, since an interaction effect with a borderline
p-value (p = 0.060) was observed ([Figure 2]).
Fig. 1 Mean pain profiles according to the visual analog scale (VAS) for each group at each
visit (t0, t1, t2, and t3).
Fig. 2 Mean pain reduction profiles according to the visual analog scale (VAS) for each
group at each visit (t0, t1, t2, and t3).
None of the analyzed variables showed that the groups were not comparable at baseline.
These data were verified using Student t-tests and Mann-Whitney tests, which revealed
p-values > 0.098. Three comparative tests for outcome variations at t1, t2 and t3
were performed separately to determine group and time effects, showing a global significance
level of 5%.
Mann-Whitney nonparametric tests analyzed the group effect over mean satisfaction
values and showed a difference between the median values of the groups at t3 (Toperma
versus Massage at t1, p = 0.677; at t2, p = 0.064; and at t3, p = 0.009). Since there was a difference between groups, the time effect was analyzed
using the Wilcoxon nonparametric test within each group. For the Toperma group, the
difference between visits (p = 0.001 for t1 versus t2; p < 0.001 for t1 versus t3; p = 0.048 for t2 versus t3) was determined, concluding that satisfaction variation
in t1 was different when compared with t2 and t3; however, these 2 last visits were
not different from each other. For the Massage group, the difference between visits
(p = 0.049 for t1 versus t2; p = 0.027 for t1 versus t3; p = 0.347 for t2 versus t3) was analyzed, revealing the lack of evidence for a time
effect in satisfaction variation ([Figure 3]).
Fig. 3 Mean personal patient satisfaction profiles for each group at each visit (t0, t1,
t2, and t3).
For functional capacity variation, nonparametric Mann-Whitney tests determined the
group effect, revealing no differences between the median values of the groups during
visits (p = 0.110 for t1; p = 0.269 for t2; p = 0.480 for t3). Since there was no difference between groups, the time effect on
the total sample was analyzed. Differences between visits were determined using the
Wilcoxon nonparametric test (p < 0.001 for t1 versus t2; p < 0.001 for t1 versus t3; p = 0.003 for t2 versus t3) and concluded that functional capacity variation is different
between visits ([Table 1]).
Table 1
|
Group
|
t0
|
t1
|
t2
|
t3
|
|
Toperma
|
|
|
|
|
|
n
|
20
|
20
|
20
|
20
|
|
Mean (SD)
|
61.0 (12.8)
|
65.5 (12.2)
|
74.8 (12.4)
|
76.8 (12.1)
|
|
95%CI
|
[55.4; 66.6]
|
[60.1; 70.9]
|
[69.3; 80.2]
|
[71.5; 82.0]
|
|
Median [Q1; Q3]
|
62.5 [55.0; 70.0]
|
70.0 [60.0; 70.0]
|
75.0 [60.0; 85.0]
|
80.0 [71.3; 85.0]
|
|
Minimum; Maximum values
|
35.0; 90.0
|
30.0; 90.0
|
55.0; 95.0
|
55.0; 95.0
|
|
Massage
|
|
|
|
|
|
n
|
17
|
17
|
17
|
17
|
|
Mean (SD)
|
58.5 (9.8)
|
50.6 (18.8)
|
66.5 (8.8)
|
69.7 (9.9)
|
|
95%CI
|
[53.9; 63.2]
|
[41.7; 59.5]
|
[62.3; 70.7]
|
[65.0; 74.4]
|
|
Median [Q1, Q3]
|
60.0 [55.0; 65.0]
|
55.0 [30.0; 70.0]
|
60.0 [60.0; 70.0]
|
70.0 [60.0; 80.0]
|
|
Minimum; Maximum values
|
25.0; 70.0
|
30.0; 80.0
|
55.0; 85.0
|
55.0; 85.0
|
|
Group
|
Group
|
Group
|
Group
|
|
|
Toperma
|
|
|
|
|
|
n
|
20
|
20
|
20
|
|
|
Mean (SD)
|
4.5 (13.4)
|
13.8 (15.5)
|
15.8 (15.0)
|
|
|
95%CI
|
[- 1.4; 10.4]
|
[6.9; 20.6]
|
[9.2; 22.3]
|
|
|
Median [Q1; Q3]
|
2.5 [0.0; 10.0]
|
5.0 [5.0; 16.3]
|
12.5 [5.0; 21.3]
|
|
|
Minimum; Maximum values
|
- 35.0; 30.0
|
- 5.0; 50.0
|
- 5.0; 50.0
|
|
|
Massage
|
|
|
|
|
|
n
|
17
|
17
|
17
|
|
|
Mean (SD)
|
- 7.9 (19.0)
|
7.9 (10.2)
|
11.2 (11.1)
|
|
|
95%CI
|
[-17.0; 1.1]
|
[3.1; 12.8]
|
[5.9; 16.5]
|
|
|
Median [Q1, Q3]
|
0.0 [-30.0; 5.0]
|
5.0 [0.0; 15.0]
|
15.0 [0.0; 20.0]
|
|
|
Minimum; Maximum values
|
-35.0; 25.0
|
-5.0; 30.0
|
-5.0; 30.0
|
|
Nonparametric Mann-Whitney tests determined the group effect over the mean values
of physical aspects, revealing a difference between medians from t1 and t3 visits
(p = 0.007 for t1; p = 0.066 for t2; and p = 0.016 for t3). The Wilcoxon test analyzed the time effect separately on each group.
For the Toperma group, there was no difference in physical aspects between visits
(p = 0.778 for t1 versus t2; p = 0.027 for t1 versus t3; p = 0.021 for t2 versus t3); the Massage group, however, presented a difference when
t1 was compared with the 2 other visits (p = 0.006 for t1 versus t2; p = 0.003 for t1 versus t3; p = 0.588 for t2 versus t3) ([Table 2]).
Table 2
|
Group
|
t0
|
t1
|
t2
|
t3
|
|
Toperma
|
|
|
|
|
|
n
|
20
|
20
|
20
|
20
|
|
Mean (SD)
|
35.0 (38.4)
|
63.8 (32.9)
|
65.0 (30.8)
|
73.8 (27.5)
|
|
95%CI
|
[18.2; 51.8]
|
[49.3; 78.2]
|
[51.5; 78.5]
|
[61.7; 85.8]
|
|
Median [Q1; Q3]
|
25.0 [0.0; 56.3]
|
50.0 [25.0; 100.0]
|
62.5 [50.0; 100.0]
|
75.0 [50.0; 100.0]
|
|
Minimum; Maximum values
|
0.0; 100.0
|
25.0; 100.0
|
0.0; 100.0
|
25.0; 100.0
|
|
Massage
|
|
|
|
|
|
n
|
17
|
17
|
17
|
17
|
|
Mean (SD)
|
52.9 (29.2)
|
51.5 (28.6)
|
69.1 (20.8)
|
70.6 (20.2)
|
|
95%CI
|
[39.1; 66.8]
|
[37.9; 65.1]
|
[59.2; 79.0]
|
[61.0; 80.2]
|
|
Median [Q1, Q3]
|
50.0 [25.0; 75.0]
|
50.0 [25.0; 75.0]
|
75.0 [50.0; 75.0]
|
75.0 [50.0; 75.0]
|
|
Minimum; Maximum values
|
0.0; 100.0
|
25.0; 100.0
|
25.0; 100.0
|
25.0; 100.0
|
|
Group
|
t1
|
t2
|
t3
|
|
|
Toperma
|
|
|
|
|
|
n
|
20
|
20
|
20
|
|
|
Mean (SD)
|
28.8 (24.7)
|
30.0 (23.8)
|
38.8 (26.3)
|
|
|
95%CI
|
[17.9; 39.6]
|
[19.6; 40.4]
|
[27.2; 50.3]
|
|
|
Median [Q1; Q3]
|
25.0 [18.8; 50.0]
|
25.0 [0.0; 50.0]
|
50.0 [25.0; 50.0]
|
|
|
Minimum; Maximum values
|
- 25.0; 75.0
|
0.0; 75.0
|
0.0; 75.0
|
|
|
Massage
|
|
|
|
|
|
n
|
17
|
17
|
17
|
|
|
Mean (SD)
|
- 1.5 (35.9)
|
16.2 (21.5)
|
17.6 (23.0)
|
|
|
95% CI
|
[- 18.5; 15.6]
|
[5.9; 26.4]
|
[6.7; 28.6]
|
|
|
Median [Q1, Q3]
|
0.0 [- 25.0; 25.0]
|
0.0 [0.0; 25.0]
|
0.0 [0.0; 25.0]
|
|
|
Minimum; Maximum values
|
- 50.0; 75.0
|
0.0; 75.0
|
0.0; 75.0
|
|
Nonparametric Mann-Whitney tests analyzed the group effect over mean pain variations
and detected no differences between the median values of the groups (p = 0.554 for t1; p = 0.734 for t2; and p = 0.091 for t3). At the SF-36 questionnaire, pain variations were different among
visits (p < 0.001 for t1 versus t2; p < 0.001 for t1 versus t3; p < 0.001 for t2 versus t3).
The group effect over the general health condition was determined with nonparametric
Mann-Whitney tests, revealing the following p-values: p = 0.347 for t1; p = 0.621 for t2; and p = 0.666 for t3. With the lack of difference between groups, differences between visits
were confirmed using the Wilcoxon test, obtaining the following p-values: p < 0.001 for t1 versus t2; p < 0.001 for t1 versus t3; p < 0.001 for t2 versus t3 ([Table 3]).
Table 3
|
Group
|
t0
|
t1
|
t2
|
t3
|
|
Toperma
|
|
|
|
|
|
n
|
20
|
20
|
20
|
20
|
|
Mean (SD)
|
61.3 (19.3)
|
64.5 (16.4)
|
74.1 (10.2)
|
77.6 (9.6)
|
|
95%CI
|
[52.8; 69.7]
|
[57.3; 71.6]
|
[69.6; 78.5]
|
[73.4; 81.8]
|
|
Median [Q1; Q3]
|
62.0 [42.0; 77.0]
|
67.0 [54.5; 77.0]
|
77.0 [67.0; 80.0]
|
78.5 [74.5; 80.5]
|
|
Minimum; Maximum values
|
32.0; 95.0
|
37.0; 100.0
|
57.0; 100.0
|
62.0; 100.0
|
|
Massage
|
|
|
|
|
|
n
|
17
|
17
|
17
|
17
|
|
Mean (SD)
|
59.6 (21.8)
|
66.9 (12.7)
|
71.2 (10.2)
|
75.1 (9.0)
|
|
95%CI
|
[49.2; 70.0]
|
[60.8; 72.9]
|
[66.4; 76.1]
|
[70.8; 79.4]
|
|
Median [Q1, Q3]
|
62.0 [50.0; 77.0]
|
67.0 [52.0; 77.0]
|
77.0 [62.0; 77.0]
|
80.0 [62.0; 80.0]
|
|
Minimum; Maximum values
|
27.0; 82.0
|
52.0; 82.0
|
57.0; 85.0
|
62.0; 85.0
|
|
Group
|
t1
|
t2
|
t3
|
|
|
Toperma
|
|
|
|
|
|
n
|
20
|
20
|
20
|
|
|
Mean (SD)
|
3.2 (11.4)
|
12.8 (11.2)
|
16.4 (12.6)
|
|
|
95%CI
|
[- 1.8; 8.2]
|
[7.9; 17.7]
|
[10.8; 21.9]
|
|
|
Median [Q1; Q3]
|
0.0 [- 1.3; 5.0]
|
9.0 [4.5; 25.0]
|
15.5 [5.0; 27.8]
|
|
|
Minimum; Maximum values
|
- 13.0; 30.0
|
0.0; 30.0
|
0.0; 35.0
|
|
|
Massage
|
|
|
|
|
|
n
|
17
|
17
|
17
|
|
|
Mean (SD)
|
7.3 (11.0)
|
11.6 (14.7)
|
15.5 (14.2)
|
|
|
95%CI
|
[2.1; 12.5]
|
[4.6; 18.7]
|
[8.7; 22.2]
|
|
|
Median [Q1, Q3]
|
0.0 [0.0; 17.0]
|
5.0 [0.0; 27.0]
|
7.0 [3.0; 27.0]
|
|
|
Minimum; Maximum values
|
- 3.0; 25.0
|
0.0; 35.0
|
0.0; 35.0
|
|
For vitality, the group effect was analyzed with Mann-Whitney nonparametric tests,
which revealed the following p-values: p = 0.173 for t1; p = 0.652 for t2; and p > 0.999 for t3. With no difference between groups, differences between visits were
detected by the Wilcoxon test, with the following p-values: p < 0.001 for t1 versus t2; p < 0.001 for t1 versus t3; p < 0.001 for t2 versus t3 ([Table 4]).
Table 4
|
Group
|
t0
|
t1
|
t2
|
t3
|
|
Toperma
|
|
|
|
|
|
n
|
20
|
20
|
20
|
20
|
|
Mean (SD)
|
60.0 (28.4)
|
63.3 (23.9)
|
71.8 (16.9)
|
74.5 (17.8)
|
|
95%CI
|
[47.5; 72.5]
|
[52.8; 73.7]
|
[64.4; 79.1]
|
[66.7; 82.3]
|
|
Median [Q1; Q3]
|
62.5 [40.0; 77.5]
|
67.5 [48.8; 80.0]
|
77.5 [57.5; 86.3]
|
80.0 [61.3; 90.0]
|
|
Minimum; Maximum values
|
10.0; 95.0
|
20.0; 95.0
|
45.0; 95.0
|
45.0; 100.0
|
|
Massage
|
|
|
|
|
|
n
|
17
|
17
|
17
|
17
|
|
Mean (SD)
|
56.8 (16.5)
|
65.3 (9.8)
|
67.9 (8.5)
|
70.0 (7.3)
|
|
95%CI
|
[48.9; 64.6]
|
[60.7; 69.9]
|
[63.9; 72.0]
|
[66.5; 73.5]
|
|
Median [Q1, Q3]
|
55.0 [40.0; 75.0]
|
65.0 [55.0; 70.0]
|
65.0 [65.0; 75.0]
|
65.0 [65.0; 75.0]
|
|
Minimum; Maximum values
|
30.0; 80.0
|
50.0; 85.0
|
55.0; 85.0
|
65.0; 85.0
|
|
Group
|
t1
|
t2
|
t3
|
|
|
Toperma
|
|
|
|
|
|
n
|
20
|
20
|
20
|
|
|
Mean (SD)
|
3.3 (7.7)
|
11.8 (16.7)
|
14.5 (17.2)
|
|
|
95%CI
|
[- 0.1; 6.6]
|
[4.4; 19.1]
|
[7.0; 22.0]
|
|
|
Median [Q1; Q3]
|
2.5 [-1.3; 10.0]
|
5.0 [0.0; 21.3]
|
10.0 [3.8; 26.3]
|
|
|
Minimum; Maximum values
|
- 10.0; 20.0
|
- 10.0; 40.0
|
- 10.0; 45.0
|
|
|
Massage
|
|
|
|
|
|
n
|
17
|
17
|
17
|
|
|
Mean (SD)
|
8.5 (11.8)
|
11.2 (13.1)
|
13.2 (13.8)
|
|
|
95%CI
|
[2.9; 14.2]
|
[5.0; 17.4]
|
[6.7; 19.8]
|
|
|
Median [Q1, Q3]
|
5.0 [0.0; 20.0]
|
10.0 [5.0; 25.0]
|
10.0 [5.0; 25.0]
|
|
|
Minimum; Maximum values
|
- 10.0; 25.0
|
- 10.0; 40.0
|
- 10.0; 45.0
|
|
The group effect over social aspects variations was defined using nonparametric Mann-Whitney
tests, which showed the following p-values for Toperma versus Massage: p = 0.371 for t1; p = 0.411 for t2; and p = 0.318 for t3. With no difference between groups, differences between visits were
confirmed with the Wilcoxon test, which revealed the following p-values: p = 0.003 for t1 versus t2; p = 0.060 for t1 versus t3; p = 0.047 for t2 versus t3 ([Table 5])
Table 5
|
Group
|
T0
|
t1
|
t2
|
t3
|
|
Toperma
|
|
|
|
|
|
n
|
20
|
20
|
20
|
20
|
|
Mean (SD)
|
70.6 (21.9)
|
76.3 (21.8)
|
80.6 (18.8)
|
78.8 (19.1)
|
|
95%CI
|
[61.0; 80.2]
|
[66.7; 85.8]
|
[72.4; 88.9]
|
[70.4; 87.1]
|
|
Median [Q1; Q3]
|
75.0 [50.0; 87.5]
|
75.0 [62.5; 100.0]
|
81.3 [75.0; 100.0]
|
75.0 [71.9; 100.0]
|
|
Minimum; Maximum values
|
25.0; 100.0
|
37.5; 100.0
|
50.0; 100.0
|
50.0; 100.0
|
|
Massage
|
|
|
|
|
|
n
|
17
|
17
|
17
|
17
|
|
Mean (SD)
|
61.5 (24.5)
|
75.0 (11.7)
|
76.5 (12.4)
|
75.7 (12.1)
|
|
95%CI
|
[49.8; 73.1]
|
[69.4; 80.6]
|
[70.6; 82.4]
|
[70.0; 81.5]
|
|
Median [Q1, Q3]
|
50.0 [40.0; 75.0]
|
75.0 [75.0; 75.0]
|
75.0 [75.0; 75.0]
|
75.0 [75.0; 75.0]
|
|
Minimum; Maximum values
|
25.0; 100.0
|
50.0; 100.0
|
50.0; 100.0
|
50.0; 100.0
|
|
Group
|
t1
|
t2
|
t3
|
|
|
Toperma
|
|
|
|
|
|
n
|
20
|
20
|
20
|
|
|
Mean (SD)
|
5.6 (16.0)
|
10.0 (16.0)
|
8.1 (14.8)
|
|
|
95%CI
|
[- 1.4; 12.6]
|
[3.0; 17.0]
|
[1.6; 14.6]
|
|
|
Median [Q1; Q3]
|
0.0 [0.0; 12.5]
|
6.3 [0.0; 15.6]
|
0.0 [0.0; 15.6]
|
|
|
Minimum; Maximum values
|
- 25.0; 37.5
|
- 12.5; 50.0
|
- 12.5; 37.5
|
|
|
Massage
|
|
|
|
|
|
n
|
17
|
17
|
17
|
|
|
Mean (SD)
|
13.5 (20.6)
|
15.0 (20.0)
|
14.3 (20.3)
|
|
|
95%CI
|
[3.7; 23.3]
|
[5.5; 24.5]
|
[4.6; 23.9]
|
|
|
Median [Q1, Q3]
|
0.0 [0.0; 35.0]
|
12.5 [0.0; 35.0]
|
12.5 [0.0; 35.0]
|
|
|
Minimum; Maximum values
|
- 25.0; 50.0
|
- 25.0; 50.0
|
- 25.0; 50.0
|
|
Nonparametric Mann-Whitney tests analyzed the group effect over mean emotional aspects,
resulting in the following p-values: p = 0.091 for t1; p = 0.057 for t2; and p = 0.018 for t3. With no difference between groups, differences between visits were
confirmed with the Wilcoxon test, which showed the following p-values: p = 0.033 for t1 versus t2; p = 0.001 for t1 versus t3; p = 0.252 for t2 versus t3.
The group effect over mental health variation was defined by nonparametric Mann-Whitney
tests, with the following p-values: p = 0.250 for t1; p = 0.763 for t2; and p = 0.740 for t3). With no difference between groups, differences between visits were
confirmed using the Wilcoxon test, obtaining the following p-values: p < 0.001 for t1 versus t2; p < 0.001 for t1 versus t3; p = 0.018 for t2 versus t3. Thus, the variation in the mental health assessment in
t1 is statistically different when compared with other visits ([Table 6]).
Table 6
|
Group
|
t0
|
t1
|
t2
|
t3
|
|
Toperma
|
|
|
|
|
|
n
|
20
|
20
|
20
|
20
|
|
Mean (SD)
|
67.0 (26.1)
|
68.0 (25.7)
|
77.6 (17.4)
|
80.6 (16.2)
|
|
95%CI
|
[55.5; 78.5]
|
[56.7; 79.3]
|
[70.0; 85.2]
|
[73.5; 87.7]
|
|
Median [Q1; Q3]
|
56.0 [55.0; 100.0]
|
64.0 [52.0; 100.0]
|
72.0 [63.0; 100.0]
|
80.0 [69.0; 100.0]
|
|
Minimum; Maximum values
|
28.0; 100.0
|
32.0; 100.0
|
56.0; 100.0
|
56.0; 100.0
|
|
Massage
|
|
|
|
|
|
n
|
17
|
17
|
17
|
17
|
|
Mean (SD)
|
64.9 (20.9)
|
69.4 (16.2)
|
76.2 (11.9)
|
76.9 (11.9)
|
|
95%CI
|
[55.0; 74.9]
|
[61.7; 77.1]
|
[70.6; 81.9]
|
[71.3; 82.6]
|
|
Median [Q1, Q3]
|
64.0 [48.0; 80.0]
|
64.0 [56.0; 80.0]
|
76.0 [64.0; 80.0]
|
76.0 [64.0; 80.0]
|
|
Minimum; Maximum values
|
40.0; 100.0
|
52.0; 100.0
|
64.0; 100.0
|
64.0; 100.0
|
|
Group
|
t1
|
t2
|
t3
|
|
|
Toperma
|
|
|
|
|
|
n
|
20
|
20
|
20
|
|
|
Mean (SD)
|
1.0 (6.9)
|
10.6 (12.2)
|
13.6 (13.6)
|
|
|
95%CI
|
[- 2.0; 4.0]
|
[5.3; 15.9]
|
[7.7; 19.5]
|
|
|
Median [Q1; Q3]
|
0.0 [0.0; 5.0]
|
8.0 [0.0; 18.0]
|
14.0 [0.0; 24.0]
|
|
|
Minimum; Maximum values
|
- 16.0; 8.0
|
0.0; 32.0
|
0.0; 32.0
|
|
|
Massage
|
|
|
|
|
|
n
|
17
|
17
|
17
|
|
|
Mean (SD)
|
4.5 (5.8)
|
11.3 (10.6)
|
12.0 (11.7)
|
|
|
95%CI
|
[1.7; 7.2]
|
[6.3; 16.3]
|
[6.4; 17.6]
|
|
|
Median [Q1, Q3]
|
0.0 [0.0; 12.0]
|
12.0 [0.0; 24.0]
|
12.0 [0.0; 24.0]
|
|
|
Minimum; Maximum values
|
- 4.0; 12.0
|
0.0; 24.0
|
- 4.0; 32.0
|
|
Discussion
Chronic postoperative neuropathic pain is a challenge for orthopedic surgeons, affecting
up to 50% of patients.[2] Although the therapeutic arsenal is extensive, encouraging results are scarce. New
therapeutic modalities, including a 5% lidocaine patch, have been tested for neuropathic
pain such as PHN.[3]
[4]
[5] The 5% lidocaine patch has a dual action, providing a mechanical barrier effect
and inactivating sodium channels. Compared with other drugs used for neuropathic pain
treatment, its main advantage is the lack of systemic effects, with reports of only
local skin reactions or application site pain. Therapeutic massage has been described
in several studies as a treatment method for postoperative scar tissue pain, with
variable outcomes.[6]
[7]
The present study analyzed and compared effects from these two therapeutic modalities
in randomized groups of patients undergoing foot and ankle surgery who continuously
presented with surgical scar tissue pain after a minimum of 3 months. Patients were
analyzed for pain (measured with the VAS), degree of personal satisfaction, and components
from the SF-36 questionnaire.
Both groups showed a pattern of pain improvement over the 3 months of treatment, with
equivalent outcomes in 90 days. However, the group treated with lidocaine showed a
greater pain reduction over time. The analysis of the variation curve ([Figure 2]) suggests that, with a longer application time, the patch becomes superior to therapeutic
massage. Outcomes in 90 days are consistent with the literature. There are no comparable
studies on lidocaine patches.
In the SF-36 questionnaire, no parameter showed a statistically significant difference
between groups, which revealed a similar improvement in pain in both groups. Regarding
functional capacity, physical aspects, vitality, emotional aspects, social aspects,
general health conditions, and mental health, there was no significant evidence to
affirm that any of the two treatment modalities had a positive or negative influence;
in addition, no difference between groups was detected.
A major advantage of the patch is the degree of personal satisfaction of the patient,
with greater, statistically significant improvement. This effect is believed to be
due to the easy application and to the psychological effect of drug therapy in comparison
with a nondrug treatment. When analyzing the variation of personal satisfaction ([Figure 3]), there was a tendency for better results over time favoring the patch.
Satisfaction, determined with a simple scale, is an important standard of assessment,
since neuropathic pain is a common reason for reports of unsuccess despite the excellent
surgical result. Our study demonstrates that the patch increases the satisfaction
of the patients with the surgical result, favoring the doctor-patient relationship.
Despite its cost, the patch has the benefits of easy adherence and a need for a lower
degree of knowledge to comply with the treatment compared with the massage, which
requires good understanding and practice.
Although this is a randomized clinical trial, our study evaluated a small number of
patients (n = 37) during a 90-day follow-up period. Our findings suggest that the treatments
would differ with longer monitoring, with better results for the patch. Due to these
limitations, it is difficult to transport these data to a general population. New
studies with a longer evaluation period are required to confirm the applicability
of the patch as a treatment method for surgical scar-related neuropathic pain, as
well as to verify whether these effects are permanent or temporary.
Conclusion
The present study shows that the lidocaine patch and manual desensitization with massage
are two effective treatment methods for pain reduction, with similar outcomes. The
lidocaine patch was also associated with an improved satisfaction with the surgical
result. Further studies are required to evaluate the applicability of these methods,
as well as to verify the duration of the analgesic effects.
Appendix 1 Brazilian Version of the Quality-of-Life Questionnaire – SF-36
Appendix 1 Brazilian Version of the Quality-of-Life Questionnaire – SF-36
1- In general, would you say your health is:
|
Excellent
|
Very Good
|
Good
|
Fair
|
Poor
|
|
1
|
2
|
3
|
4
|
5
|
2- Compared with one year ago, how would you rate your health in general now?
|
Much better
|
Somewhat better
|
About the same
|
Somewhat worse
|
Much worse
|
|
1
|
2
|
3
|
4
|
5
|
3- The following items are about activities you might do during a typical day. Does
your health now limit you in these activities? If so, how much?
|
Activities
|
Yes, it limits a lot
|
Yes, it limits a little
|
No, it does not limit at all
|
|
a) Vigorous activities, such as running, lifting heavy objects, participating in strenuous
sports.
|
1
|
2
|
3
|
|
b) Moderate activities, such as moving a table, using vacuum cleaner, playing ball,
sweeping the floor.
|
1
|
2
|
3
|
|
c) Lifting or carrying groceries
|
1
|
2
|
3
|
|
d) Climbing several flights of stairs
|
1
|
2
|
3
|
|
e) Climbing one flight of stairs
|
1
|
2
|
3
|
|
f) Bending, kneeling, or stooping
|
1
|
2
|
3
|
|
g) Walking more than a kilometer
|
1
|
2
|
3
|
|
h) Walking several blocks
|
1
|
2
|
3
|
|
i) Walking one block
|
1
|
2
|
3
|
|
j) Bathing or dressing yourself
|
1
|
2
|
3
|
4- During the past 4 weeks, have you had any of the following problems with your work
or other regular daily activities as a result of your physical health?
|
Yes
|
No
|
|
a) Cut down the amount of time you spent on work or other activities?
|
1
|
2
|
|
b) Accomplished less than you would like?
|
1
|
2
|
|
c) Were limited in the kind of work or other activities.
|
1
|
2
|
|
d) Had difficulty performing the work or other activities (for example, it took extra
effort)
|
1
|
2
|
5- During the past 4 weeks, have you had any of the following problems with your work
or other regular daily activities as a result of any emotional problems (such as feeling
depressed or anxious)?
|
Yes
|
No
|
|
a) Cut down the amount of time you spent on work or other activities?
|
1
|
2
|
|
b) Accomplished less than you would like?
|
1
|
2
|
|
c) Didn't do work or other activities as carefully as usual.
|
1
|
2
|
6- During the past 4 weeks, how your physical health or emotional problems interfered
with your normal social activities with family, friends, or groups?
|
Not at all
|
Slightly
|
Moderately
|
Severe
|
Very severely
|
|
1
|
2
|
3
|
4
|
5
|
7- How much bodily pain have you had during the past 4 weeks?
|
None
|
Very Mild
|
Mild
|
Moderate
|
Severe
|
Very severe
|
|
1
|
2
|
3
|
4
|
5
|
6
|
8- During the past 4 weeks, how much did pain interfere with your normal work (including
housework)?
|
Not at all
|
Slightly
|
Moderately
|
Severe
|
Very severe
|
|
1
|
2
|
3
|
4
|
5
|
9- These questions are about how you feel and how things have been with you during
the last 4 weeks. For each question, please give the answer that comes closest to
the way you have been feeling.
|
All of the time
|
Most of the time
|
A good bit of the time
|
Some of the time
|
A little bit of the time
|
None of the time
|
|
a) Did you feel full of pep?
|
1
|
2
|
3
|
4
|
5
|
6
|
|
b) Have you been a very nervous person?
|
1
|
2
|
3
|
4
|
5
|
6
|
|
c) Have you felt so down in the dumps that nothing could cheer you up?
|
1
|
2
|
3
|
4
|
5
|
6
|
|
d) Have you felt calm and peaceful?
|
1
|
2
|
3
|
4
|
5
|
6
|
|
e) Did you have a lot of energy?
|
1
|
2
|
3
|
4
|
5
|
6
|
|
f) Have you felt downhearted and blue?
|
1
|
2
|
3
|
4
|
5
|
6
|
|
g) Did you feel worn out?
|
1
|
2
|
3
|
4
|
5
|
6
|
|
h) Have you been a happy person?
|
1
|
2
|
3
|
4
|
5
|
6
|
|
i) Did you feel tired?
|
1
|
2
|
3
|
4
|
5
|
6
|
10- During the past 4 weeks, how much of the time has your physical health or emotional
problems interfered with your social activities (like visiting with friends, relatives,
etc.)?
|
All of the time
|
Most of the time
|
A good bit of the time
|
Some of the time
|
A little bit of the time
|
|
1
|
2
|
3
|
4
|
5
|
11- How true or false is each of the following statements for you?
|
Definitely true
|
Mostly true
|
I do not know
|
Mostly false
|
Definitely false
|
|
a) I seem to get sick a little easier than other people
|
1
|
2
|
3
|
4
|
5
|
|
b) I am as healthy as anybody I know
|
1
|
2
|
3
|
4
|
5
|
|
c) I expect my health to get worse
|
1
|
2
|
3
|
4
|
5
|
|
d) My health is excellent
|
1
|
2
|
3
|
4
|
5
|
QUALITY-OF-LIFE SCORING CALCULATION
QUALITY-OF-LIFE SCORING CALCULATION
Phase 1: Data ponderation
|
Question
|
Score
|
|
01
|
If the answer was
1
2
3
4
5
|
Score
5.0
4.4
3.4
2.0
1.0
|
|
02
|
Keep the same value
|
|
03
|
All values are added
|
|
04
|
All values are added
|
|
05
|
All values are added
|
|
06
|
If the answer was
1
2
3
4
5
|
Score
5
4
3
2
1
|
|
07
|
If the answer was
1
2
3
4
5
6
|
Score
6.0
5.4
4.2
3.1
2.0
1.0
|
|
08
|
The answer to question 8 is based on the score from question 7
If 7 = 1 and if 8 = 1, the score is (6)
If 7 = 2 to 6 and 8 = 1, the score is (5)
If 7 = 2 to 6 and if 8 = 2, the score is (4)
If 7 = 2 to 6 and if 8 = 3, the score is (3)
If 7 = 2 to 6 and if 8 = 4, the score is (2)
If 7 = 2 to 6 and if 8 = 3, the score is (1)
If question 7 was not answered, question 8 score will be the following:
If the answer was (1), the score will be (6)
If the answer was (2), the score will be (4.75)
If the answer was (3), the score will be (3.5)
If the answer was (4), the score will be (2.25)
If the answer was (5), the score will be (1.0)
|
|
09
|
For this question, the score for items a, d, e, and h should follow these guidelines:
If the answer was 1, the score will be (6)
If the answer was 2, the score will be (5)
If the answer was 3, the score will be (4)
If the answer was 4, the score will be (3)
If the answer was 5, the score will be (2)
If the answer was 6, the score will be (1)
For the remaining items (b, c, f, g, and i), the score should be the same
|
|
10
|
Consider the same score.
|
|
11
|
For this question, items should be added; however, items b and d should follow these
guidelines:
If the answer was 1, the score will be (5)
If the answer was 2, the score will be (4)
If the answer was 3, the score will be (3)
If the answer was 4, the score will be (2)
If the answer was 5, the score will be (1)
|
Domain:
To do so, apply the following formula to calculate each domain:
Domain:
For this formula, the lower limit and score range are fixed and stipulated at the
following table.
|
Domain
|
Score at corresponding questions
|
Lower limit
|
Score range
|
|
Functional capacity
|
03
|
10
|
20
|
|
Limitation due to physical aspects
|
04
|
4
|
4
|
|
Pain
|
07 + 08
|
2
|
10
|
|
General health condition
|
01 + 11
|
5
|
20
|
|
Vitality
|
09 (only for items a + e + g + i)
|
4
|
20
|
|
Social aspects
|
06 + 10
|
2
|
8
|
|
Limitation due to emotional aspects
|
05
|
3
|
3
|
|
Mental health
|
09 (only for items b + c + d + f + h)
|
5
|
25
|
