Acessibilidade / Reportar erro

Application of 5% Lidocaine Adhesive Patch in Painful Surgical Scars: Clinical Trial* * Study performed at the Orthopedics and Traumatology Service, Hospital Ipiranga, São Paulo, SP, Brazil.

Resumo

Objetivo

Avaliar o emplastro de lidocaína 5% como método de tratamento da dor neuropática após cirurgias ortopédicas em comparação com massagem terapêutica realizada sobre incisões.

Métodos

Trata-se de um ensaio clínico prospectivo, randomizado, com 37 pacientes submetidos a cirurgia ortopédica entre janeiro de 2015 e fevereiro de 2017. Foram incluídos pacientes com idade entre 13 e 70 anos que foram submetidos a cirurgia ortopédica no pé e tornozelo com dor neuropática ou hipersensibilidade na incisão cirúrgica por no mínimo 90 dias após o procedimento. Todos os indivíduos foram avaliados segundo a escala visual analógica (EVA) de dor e o questionário de qualidade de vida SF-36 no início do tratamento e após 30, 60 e 90 dias.

Resultados

Os dois grupos apresentaram melhora da dor; porém, o grupo que utilizou o emplastro apresentou maior redução com o passar do tempo. Em relação aos parâmetros do questionário SF-36, nenhum deles demonstrou diferença estatisticamente relevante. Em relação à capacidade funcional, aos aspectos físicos, à vitalidade, aos aspectos emocionais, aos aspectos sociais, ao estado geral de saúde e saúde mental, não houve evidências significativas. A grande vantagem do emplastro está no grau de satisfação pessoal dos pacientes, com relevância estatística, provavelmente pela facilidade de aplicação e pelo efeito psicológico de uma terapia medicamentosa.

Conclusão

O emplastro e a massagem são métodos de tratamento eficazes na redução da dor cicatricial, apresentando resultados semelhantes. O emplastro está associado à melhora do grau de satisfação dos pacientes. Nível de Evidência 1. Ensaio clínico prospectivo randomizado.

Keywords
orthopedic procedures; pain; neuralgia; lidocaine; massage

Resumo

Objetivo

Avaliar o emplastro de lidocaína 5% como método de tratamento da dor neuropática após cirurgias ortopédicas em comparação com massagem terapêutica realizada sobre incisões.

Métodos

Trata-se de um ensaio clínico prospectivo, randomizado, com 37 pacientes submetidos a cirurgia ortopédica entre janeiro de 2015 e fevereiro de 2017. Foram incluídos pacientes com idade entre 13 e 70 anos que foram submetidos a cirurgia ortopédica no pé e tornozelo com dor neuropática ou hipersensibilidade na incisão cirúrgica por no mínimo 90 dias após o procedimento. Todos os indivíduos foram avaliados segundo a escala visual analógica (EVA) de dor e o questionário de qualidade de vida SF-36 no início do tratamento e após 30, 60 e 90 dias.

Resultados

Os dois grupos apresentaram melhora da dor; porém, o grupo que utilizou o emplastro apresentou maior redução com o passar do tempo. Em relação aos parâmetros do questionário SF-36, nenhum deles demonstrou diferença estatisticamente relevante. Em relação à capacidade funcional, aos aspectos físicos, à vitalidade, aos aspectos emocionais, aos aspectos sociais, ao estado geral de saúde e saúde mental, não houve evidências signifìcativas. A grande vantagem do emplastro está no grau de satisfação pessoal dos pacientes, com relevância estatística, provavelmente pela facilidade de aplicação e pelo efeito psicológico de uma terapia medicamentosa.

Conclusão

O emplastro e a massagem são métodos de tratamento efìcazes na redução da dor cicatricial, apresentando resultados semelhantes. O emplastro está associado à melhora do grau de satisfação dos pacientes. Nível de Evidência 1. Ensaio clínico prospectivo randomizado.

Objective

The present paper aims to evaluate the use of a 5% lidocaine patch to treat neuropathic pain after orthopedic procedures in comparison with therapeutic massage over surgical incisions.

Methods

This is a prospective, randomized clinical trial with 37 patients who underwent orthopedic surgery from January 2015 to February 2017. The study included subjects aged 13 to 70 years old who underwent foot and ankle orthopedic surgery and presented neuropathic pain or hypersensitivity at the surgical incision site for at least 90 days after the procedure. All patients were assessed for pain (using the visual analog scale [VAS]) and quality of life (with the SF-36 questionnaire) at the beginning of the treatment and after 30, 60, and 90 days.

Results

Although the treatment improved pain in both groups, subjects using the lidocaine patch presented greater pain reduction over time. There were no statistically significant differences in the SF-36 questionnaire, with no significant evidence regarding functional capacity, physical aspects, vitality, emotional aspects, social aspects, general health condition, and mental health. The great advantage of the patch was the degree of personal satisfaction of the patients, with statistical relevance, probably due to the easy application and psychological effect of a drug therapy.

Conclusion

Lidocaine patches and massages are effective treatment methods for reducing scar tissue pain, with similar outcomes. The patches improved the degree of patient satisfaction. Level of Evidence 1. Prospective randomized clinical trial.

Palavras-chave
procedimentos ortopédicos; dor; neuralgia; lidocaína; massagem

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.11 de León-Casasola OA, Mayoral V. The topical 5% lidocaine medicated plaster in localized neuropathic pain: a reappraisal of the clinical evidence. J Pain Res 2016;9:67–79 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;22 Tornetta P 3rd, Court-Brown M, Heckman JD. Rockwood and Green’s fractures in adults. 8th ed. Philadelphia: Wolters Kluwer Health; 2015 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.33 Nayak S, Cunliffe M. Lidocaine 5% patch for localized chronic neuropathic pain in adolescents: report of five cases. Paediatr Anaesth 2008;18(06):554–558 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 pre-gabalin in these subjects.33 Nayak S, Cunliffe M. Lidocaine 5% patch for localized chronic neuropathic pain in adolescents: report of five cases. Paediatr Anaesth 2008;18(06):554–55855 Hadley GR, Gayle JA, Ripoll J, et al. Post-herpetic neuralgia: a review. Curr Pain Headache Rep 2016;20(03):17

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.66 Masanovic MG. [Physical therapy for scars]. Soins 2013;(772): 41–43 A recent literature review reported the positive effect of massage on surgical scars in 90% of the patients treated for 30 to 180 days.77 ShinTM, Bordeaux JS. The role of massage in scar management: a literature review. Dermatol Surg 2012;38(03):414–423 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 Appendix 1 Brazilian Version of the Quality-of-Life Questionnaire – SF-36 1- In general, would you say your health is: ExcellentVery GoodGoodFairPoor12345 2- Compared with one year ago, how would you rate your health in general now? Much betterSomewhat betterAbout the sameSomewhat worseMuch worse12345 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? ActivitiesYes, it limits a lotYes, it limits a littleNo, it does not limit at alla) Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports.123b) Moderate activities, such as moving a table, using vacuum cleaner, playing ball, sweeping the floor.123c) Lifting or carrying groceries123d) Climbing several flights of stairs123e) Climbing one flight of stairs123f) Bending, kneeling, or stooping123g) Walking more than a kilometer123h) Walking several blocks123i) Walking one block123j) Bathing or dressing yourself123 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? YesNoa) Cut down the amount of time you spent on work or other activities?12b) Accomplished less than you would like?12c) Were limited in the kind of work or other activities.12d) Had difficulty performing the work or other activities (for example, it took extra effort)12 5- During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities a result of any emotional problems (such as feeling depressed or anxious)? YesNoa) Cut down the amount of time you spent on work or other activities?12b) Accomplished less than you would like?12c) Didn’t do work or other activities as carefully as usual.12 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 allSlightlyModeratelySevereVery severely12345 7- How much bodily pain have you had during the past 4 weeks? NoneVery MildMildModerateSevereVery severe123456 8- During the past 4 weeks, how much did pain interfere with your normal work (including housework)? Not at allSlightlyModeratelySevereVery severe12345 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 timeMost of the timeA good bit of the timeSome of the timeA little bit of the timeNone of the timea) Did you feel full of pep?123456b) Have you been a very nervous person?123456c) Have you felt so down in the dumps that nothing could cheer you up?123456d) Have you felt calm and peaceful?123456e) Did you have a lot of energy?123456f) Have you felt downhearted and blue?123456g) Did you feel worn out?123456h) Have you been a happy person?123456i) Did you feel tired?123456 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 timeMost of the timeA good bit of the timeSome of the timeA little bit of the time12345 11- How true or false is each of the following statements for you? Definitely trueMostly trueI do not knowMostly falseDefinitely falsea) I seem to get sick a little easier than other people12345b) I am as healthy as anybody I know12345c) I expect my health to get worse12345d) My health is excellent12345 ) 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).

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).

Fig. 3
Mean personal patient satisfaction profiles for each group at each visit (t0, t1, t2, and t3).

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).

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).

Table 1
Summary measures for functional capacity in each group and each visit [t0, t1, t2 and t3] and variation among t1, t2, and t3 visits
Table 2
Summary measures for physical aspects in each group and each visit [t0, t1, t2 and t3] and variation among t1, t2, and t3 visits

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).

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).

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 followingp-values:p = 0.003 for t1 versus t2;p = 0.060 for t1 versus t3; p = 0.047 for t2 versus t3 (►Table 5)

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 fort2; 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 3
Summary measures for general health condition in each group and each visit [t0, t1, t2 and t3] and variation among t1, t2, and t3 visits
Table 4
Summary measures for vitality in each group and each visit [t0, t1, t2 and t3] and variation among t1, t2, and t3 visits
Table 5
Summary measures for social aspects in each group and each visit [t0, t1, t2 and t3] and variation among t1, t2, and t3 visits
Table 6
Summary measures for mental health in each group and each visit [t0, t1, t2 and t3] and variation among t1, t2, and t3 visits

Discussion

Chronic postoperative neuropathic pain is a challenge for orthopedic surgeons, affecting up to 50% of patients.22 Tornetta P 3rd, Court-Brown M, Heckman JD. Rockwood and Green’s fractures in adults. 8th ed. Philadelphia: Wolters Kluwer Health; 2015 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.33 Nayak S, Cunliffe M. Lidocaine 5% patch for localized chronic neuropathic pain in adolescents: report of five cases. Paediatr Anaesth 2008;18(06):554–55855 Hadley GR, Gayle JA, Ripoll J, et al. Post-herpetic neuralgia: a review. Curr Pain Headache Rep 2016;20(03):17 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.66 Masanovic MG. [Physical therapy for scars]. Soins 2013;(772): 41–43,77 ShinTM, Bordeaux JS. The role of massage in scar management: a literature review. Dermatol Surg 2012;38(03):414–423

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.

Authors’ Contribution

Each author contributed individually and significantly to the development of the present article. Macedo R. R. (00000002-2563-2085)*, Santos J. P. G. (0000-0002-1086-9872)*, Lobato E. S. (0000-0002-7181-6133)* and Mendes Júnior J. P. (0000-0003-1514-5029)* were the main collaborators for manuscript preparation. Santos J. P. G. (0000-0002-1086-9872)*, Lobato E. S. (0000-0002-7181-6133)* and Mendes Júnior J. P. (0000-0003-1514-5029)* performed the followup of the patients and collected clinical data. Santos J. P. G. (0000-0002-1086-9872)*, Lobato E. S. (0000-0002-7181-6133)* and Mendes Júnior J. P. (0000-0003-1514-5029)* evaluated the data for statistical analysis. Macedo R. R. (0000-0002-2563-2085)*, Santos J. P. G. (0000-0002-1086-9872)*, Lobato E. S. (0000-0002-7181-6133)* and Mendes Júnior J. P. (0000-0003-1514-5029)* conducted the literature review. Ikemoto R. Y. (0000-0001-7718-1186)* and Rodrigues L. M. R. (0000-0001-6891-5395)* reviewed the manuscript and contributed to the intellectual concept of the study. *ORCID (Open Researcher and Contributor ID).

  • 1
    de León-Casasola OA, Mayoral V. The topical 5% lidocaine medicated plaster in localized neuropathic pain: a reappraisal of the clinical evidence. J Pain Res 2016;9:67–79
  • 2
    Tornetta P 3rd, Court-Brown M, Heckman JD. Rockwood and Green’s fractures in adults. 8th ed. Philadelphia: Wolters Kluwer Health; 2015
  • 3
    Nayak S, Cunliffe M. Lidocaine 5% patch for localized chronic neuropathic pain in adolescents: report of five cases. Paediatr Anaesth 2008;18(06):554–558
  • 4
    Liedgens H, Obradovic M, Nuijten M. Health economic evidence of 5% lidocaine medicated plaster in post-herpetic neuralgia. Clinicoecon Outcomes Res 2013;5(01):597–609
  • 5
    Hadley GR, Gayle JA, Ripoll J, et al. Post-herpetic neuralgia: a review. Curr Pain Headache Rep 2016;20(03):17
  • 6
    Masanovic MG. [Physical therapy for scars]. Soins 2013;(772): 41–43
  • 7
    ShinTM, Bordeaux JS. The role of massage in scar management: a literature review. Dermatol Surg 2012;38(03):414–423

Appendix 1 Brazilian Version of the Quality-of-Life Questionnaire – SF-36

  • 1-

    In general, would you say your health is:

    ExcellentVery GoodGoodFairPoor12345

  • 2-

    Compared with one year ago, how would you rate your health in general now?

    Much betterSomewhat betterAbout the sameSomewhat worseMuch worse12345

  • 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?

    ActivitiesYes, it limits a lotYes, it limits a littleNo, it does not limit at alla) Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports.123b) Moderate activities, such as moving a table, using vacuum cleaner, playing ball, sweeping the floor.123c) Lifting or carrying groceries123d) Climbing several flights of stairs123e) Climbing one flight of stairs123f) Bending, kneeling, or stooping123g) Walking more than a kilometer123h) Walking several blocks123i) Walking one block123j) Bathing or dressing yourself123

  • 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?

    YesNoa) Cut down the amount of time you spent on work or other activities?12b) Accomplished less than you would like?12c) Were limited in the kind of work or other activities.12d) Had difficulty performing the work or other activities (for example, it took extra effort)12

  • 5-

    During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities a result of any emotional problems (such as feeling depressed or anxious)?

    YesNoa) Cut down the amount of time you spent on work or other activities?12b) Accomplished less than you would like?12c) Didn’t do work or other activities as carefully as usual.12

  • 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 allSlightlyModeratelySevereVery severely12345

  • 7-

    How much bodily pain have you had during the past 4 weeks?

    NoneVery MildMildModerateSevereVery severe123456

  • 8-

    During the past 4 weeks, how much did pain interfere with your normal work (including housework)?

    Not at allSlightlyModeratelySevereVery severe12345

  • 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 timeMost of the timeA good bit of the timeSome of the timeA little bit of the timeNone of the timea) Did you feel full of pep?123456b) Have you been a very nervous person?123456c) Have you felt so down in the dumps that nothing could cheer you up?123456d) Have you felt calm and peaceful?123456e) Did you have a lot of energy?123456f) Have you felt downhearted and blue?123456g) Did you feel worn out?123456h) Have you been a happy person?123456i) Did you feel tired?123456

  • 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 timeMost of the timeA good bit of the timeSome of the timeA little bit of the time12345

  • 11-

    How true or false is each of the following statements for you?

    Definitely trueMostly trueI do not knowMostly falseDefinitely falsea) I seem to get sick a little easier than other people12345b) I am as healthy as anybody I know12345c) I expect my health to get worse12345d) My health is excellent12345

QUALITY-OF-LIFE SCORING CALCULATION

Phase 1:
Data ponderation
Domain:
  • • Functional capacity

  • • Limitation due to physical aspects

  • • Pain

  • • General health condition

  • • Vitality

  • • Social aspects

  • • Emotional aspects

  • • Mental health

    To do so, apply the following formula to calculate each domain:

    Domain:

    Valor obtido nas questões correspondentes Limite inferior ×100Variação(Score Range)

    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

Publication Dates

  • Publication in this collection
    17 Dec 2021
  • Date of issue
    Nov-Dec 2021

History

  • Received
    05 Oct 2020
  • Accepted
    08 Mar 2021
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