ABSTRACT
INTRODUCTION: Photobiomodulation (PBM) using low-level laser can affect tissue repair mechanisms and seems promising in reducing pain intensity. However, few studies support the effectiveness of PBM on postpartum period complications, such as nipple and/or perineal trauma and pain, probably due to the low doses used. The primary objective of this study is to analyse the effectiveness of PBM on pain intensity in the nipple and perineal trauma in women in the immediate postpartum period. Secondary objectives are to evaluate the effect on tissue healing and the women's satisfaction. METHODS AND ANALYSIS: A double-blind, multicentre, parallel-group, randomised controlled trial will be performed in two public referral maternity hospitals in Brazil with 120 participants, divided into two arms: 60 participants in the nipple trauma arm and 60 participants in the perineal trauma arm. Participants will be women in the immediate postpartum period, who present with nipple trauma or perineal trauma and report pain intensity greater than or equal to 4 points on the Numerical Rating Scale for Pain. Block randomisation will be performed, followed by blinding allocation. In the experimental group, one application of PBM will be performed between 6 hours and 36 hours after birth. For the sham group, the simulation will be carried out without triggering energy. Both participants and the research evaluator will be blinded to the allocation group. Intention-to-treat method and the between-group and within-group outcome measures analysis will be performed. ETHICS AND DISSEMINATION: This research protocol was approved by the Research Ethics Committees of the University of Campinas, Brazil, and of the School Maternity Assis Chateaubriand, Brazil (numbers CAAE: 59400922.1.1001.5404; 59400922.1.3001.5050). Participants will be required to sign the informed consent form to participate. Results will be disseminated to the health science community. TRIAL REGISTRATION NUMBER: Brazilian Registry of Clinical Trials (RBR-2qm8jrp).
Subject(s)
Low-Level Light Therapy , Humans , Pregnancy , Female , Nipples , Pain Measurement , Postpartum Period , Pain/etiology , Pain/radiotherapy , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
CONTEXT AND OBJECTIVE: Systematic modifications to the surgical technique of mastectomy have been proposed with the objective of minimizing injuries to the pectoral nerves and their effects. The aim of this study was to compare muscle strength and mass of the pectoralis major muscle (PMM) and abduction and flexion of the homolateral upper limb following mastectomy among women with breast cancer undergoing either preservation or sectioning of the medial pectoral nerve (MPN). DESIGN AND SETTING: Randomized, double-blind, clinical trial on 30 women with breast cancer who underwent mastectomy between July 2002 and May 2003 in Campinas, Brazil. METHODS: The women were allocated to a group, in which the MPN was preserved, or to another group in which it was sectioned. Fisher's exact and Wilcoxon tests were used to analyze the data, along with Friedman and ANOVA analysis of variance. RESULTS: In the MPN preserved group, 81% of the women did not lose any PMM strength, compared with 31% in the sectioned MPN group (confidence interval, CI = 1.21; relative risk, RR = 2.14; P < 0.03). There were no differences between the groups regarding muscle mass (CI = 0.32; RR = 0.89; P = 0.8), shoulder abduction (CI = 1.36; RR = 0.89; P = 0.28) and shoulder flexion (CI = 1.36; RR = 1.93; P = 0.8). CONCLUSIONS: Preservation of the MPN was significantly associated with maintenance of PMM strength, compared with nerve sectioning. No differences in muscle mass or in abduction and flexion of the homolateral shoulder were found between the groups. CLINICAL TRIAL REGISTRATION NUMBER: ANZCTR - 00082622.
Subject(s)
Breast Neoplasms/surgery , Carcinoma/surgery , Mastectomy/rehabilitation , Pectoralis Muscles/innervation , Upper Extremity/physiology , Adult , Aged , Epidemiologic Methods , Female , Humans , Mastectomy/methods , Middle Aged , Movement/physiology , Muscle Strength/physiology , Pectoralis Muscles/physiology , Peripheral Nerves/physiology , Peripheral Nerves/surgeryABSTRACT
CONTEXT AND OBJECTIVE: Systematic modifications to the surgical technique of mastectomy have been proposed with the objective of minimizing injuries to the pectoral nerves and their effects. The aim of this study was to compare muscle strength and mass of the pectoralis major muscle (PMM) and abduction and flexion of the homolateral upper limb following mastectomy among women with breast cancer undergoing either preservation or sectioning of the medial pectoral nerve (MPN). DESIGN AND SETTING: Randomized, double-blind, clinical trial on 30 women with breast cancer who underwent mastectomy between July 2002 and May 2003 in Campinas, Brazil. METHODS: The women were allocated to a group, in which the MPN was preserved, or to another group in which it was sectioned. Fisher's exact and Wilcoxon tests were used to analyze the data, along with Friedman and ANOVA analysis of variance. RESULTS: In the MPN preserved group, 81 percent of the women did not lose any PMM strength, compared with 31 percent in the sectioned MPN group (confidence interval, CI = 1.21; relative risk, RR = 2.14; P < 0.03). There were no differences between the groups regarding muscle mass (CI = 0.32; RR = 0.89; P = 0.8), shoulder abduction (CI = 1.36; RR = 0.89; P = 0.28) and shoulder flexion (CI = 1.36; RR = 1.93; P = 0.8). CONCLUSIONS: Preservation of the MPN was significantly associated with maintenance of PMM strength, compared with nerve sectioning. No differences in muscle mass or in abduction and flexion of the homolateral shoulder were found between the groups. CLINICAL TRIAL REGISTRATION NUMBER: ANZCTR - 00082622
CONTEXTO E OBJETIVO: Modificações sistemáticas técnica cirúrgica das mastectomias têm sido propostas com o objetivo de minimizar lesões dos nervos peitorais e seus efeitos. O objetivo deste artigo foi comparar força e trofismo do músculo peitoral maior (MPM) e amplitude de movimento do membro superior, homolaterais à mastectomia em mulheres com carcinoma de mama submetidas à preservação ou não do nervo peitoral medial (NPM). TIPO DE ESTUDO E LOCAL: Ensaio clínico aleatório, duplo-cego, com 30 mulheres com carcinoma de mama submetidas a mastectomias entre julho de 2002 e maio de 2003, em Campinas, Brasil. MÉTODOS: As mulheres foram alocadas em um grupo em que o NPM foi preservado e em outro no qual o NPM foi seccionado. Para análise de dados, foram utilizados os testes exato de Fisher e Wilcoxon, além das análises de variância de Friedman e Anova (análise de variância). RESULTADOS: No grupo com NPM preservado, 81 por cento das mulheres não sofreram perda de força do MPM comparado a 31 por cento no outro grupo (intervalo de confiança, IC = 1.21 e risco relativo, RR = 2.14, P < 0,03). Em relação a trofismo muscular (IC = 0.32 e RR = 0.89, P = 0.8), a abdução (IC = 1.36, RR = 0.89, P = 0.28) e flexão (IC = 1.36, RR = 1.93 e P = 0.8) do ombro homolateral, não houve diferenças entre os grupos. CONCLUSÃO: A preservação do MPM foi significativamente associada a manutenção da força do MPM comparada com a secção do nervo. Não foram encontradas diferenças no trofismo muscular ou na amplitude de movimento do ombro entre os grupos. REGISTRO DE ENSAIO CLÍNICO NÚMERO: ANZCTR - 00082622
Subject(s)
Adult , Aged , Female , Humans , Middle Aged , Breast Neoplasms/surgery , Carcinoma/surgery , Mastectomy/rehabilitation , Pectoralis Muscles/innervation , Upper Extremity/physiology , Epidemiologic Methods , Mastectomy/methods , Movement/physiology , Muscle Strength/physiology , Pectoralis Muscles/physiology , Peripheral Nerves/physiology , Peripheral Nerves/surgeryABSTRACT
Objetivo: Comparar a eficácia de um programa de reabilitação física domiciliar por meio de manual ilustrativo para mulheres operadas por câncer mamário com um programa de exercícios físicos supervisionados por fisioterapeuta. Ensaio clínico prospectivo incluindo 56 mulheres submetidas à cirurgia por câncer de mama, randomizadas em dois grupos: (1) 28 mulheres participantes do programa de reabilitação supervisionado por fisioterapeuta e (2) 28 mulheres orientadas a fazer exercícios físicos em domicílio utilizando manual ilustrativo. Nos dois grupos os exercícios físicos foram realizados em duas sessões semanais durante dois meses. Avaliaram-se a flexão e a abdução do ombro através da goniometria, a aderência cicatricial através da palpação, e as dificuldades para comparecer às sessões (grupo 1) ou realizar os exercícios físicos em domicílio (grupo 2), segundo questionário elaborado previamente.A mobilidade do ombro diminuiu em ambos os grupos quinze dias após a cirurgia com recuperação progressiva. Após dois meses permaneceu um déficit médio de 6° de flexão de ombro de 13,4° e 7,7°, respectivamente. Vestir-se e cuidar da higiene foram as atividades mais difíceis em ambos os grupos. Nas mulheres do grupo 1, os efeitos colaterais da quimioterapia justificaram 55 das faltas. Entre as mulheres do grupo 2, 46...
