This study evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months, in breast cancer needing physiotherapy, following a total mastectomy and exploratory axillary surgery.
A prospective, monocentric, randomized, open-labelled in two parallel groups study that evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months in breast cancer patients needing physiotherapy, following a total mastectomy and exploratory axillary surgery. Other objectives of the study include: * Evaluate the efficacy of mechanical stimulation technique compared to massages on pain and functional discomfort (on the mobility of the shoulder) 15 days after the end of physiotherapy. * Evaluate the impact of mechanical stimulation on the quality of life of patients, in comparison to those receiving massages
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
The technique of mechanical stimulation alternates between compression and decompression of the treated area. It aims to reestablish a good blood circulation and lymphatic drainage.
Massages will be carried out according to a specific regime as specified in the study protocol. The massages will be done in 15 sessions of 30 minutes each, done twice a week and will consist of: * One part muscle exercise * One part skin work (drainage)
Centre Oscar Lambret
Lille, Hauts-de-France, France
Centre Hospitalier Universitaire de Lille
Lille, France
Pain level by a numerical scale
Pain level will be evaluated using a numerical scale of pain
Time frame: 6 months after randomization
Pain level by using Brief Pain Inventory
Pain level will be evaluated using Brief Pain Inventory (BPI), there is no global score for this questionnaire, each item must be considered separately.
Time frame: 6 months after randomization
Pain level by using QDN4 questionnaire
Pain level will be evaluated using QDN4 questionnaire, which is a pain scale from 0 to 10.
Time frame: 6 months after randomization
Mobility of the shoulders
Will be evaluated using the Constant score based on the study by Constant CR, Murley AHG. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987;(214):160-4. Pain level, level of daily activities and physical mobility will be assessed with a a scale adapted according to the gender and the patients age.
Time frame: 6 months after randomization
Pain level by a numerical scale
Pain level will be evaluated using a numerical scale of pain
Time frame: 15 days after the end of physiotherapy
Pain level by using Brief Pain Inventory
Pain level will be evaluated using Brief Pain Inventory (BPI), there is no global score for this questionnaire, each item must be considered separately.
Time frame: 15 days after the end of physiotherapy
Pain level by using QDN4 questionnaire
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Pain level will be evaluated using QDN4 questionnaire, which is a pain scale from 0 to 10.
Time frame: 15 days after the end of physiotherapy
Mobility of the shoulders
Will be evaluated using the Constant score based on the study by Constant CR, Murley AHG. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987;(214):160-4. Pain level, level of daily activities and physical mobility will be assessed with a a scale adapted according to the gender and the patients age.
Time frame: 15 days after the end of physiotherapy
Anxiety
Will be evaluated using the Hospital Anxiety and Depression Scale (HADS) questionnaire. The questionnaire consists of a list of questions to determine the level of anxiety and depression experienced by the patients. Each question is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression: * A score equal to or less than 7 indicates no symptoms, * A score of 8 - 10 indicates a questionable symptoms, * A score of 11 and above confirms of the presence of anxiety and/or depression symptoms
Time frame: at the baseline and 6 months after
Quality of Life (QoL) with EORTC-QLQ-C30
Will be evaluated using the EORTC-QLQ-C30 questionnaire. This questionnaire aim to assess the quality of life of cancer. It is composed of 30 questions. In this questionnaire, the items are scored from 1-4, where 1 = not at all, 2 = a little, 3 = quite a bit and 4 = very much. Only 2 items in the EORTC-QLQ-C30 questionnaire are scored from 1-7, where 1 is very poor and 7 is excellent.
Time frame: at the baseline and 6 months after
Quality of Life (QoL) with EORTC-QLQ-BR23
Will be evaluated using the EORTC-QLQ-BR23 questionnaire. This questionnaire aim to assess the quality of life of cancer. It is composed of 23 questions. In this questionnaire, the items are scored from 1-4, where 1 = not at all, 2 = a little, 3 = quite a bit and 4 = very much.
Time frame: at the baseline and 6 months after