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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02377-50 | Other Identifier | ANSM |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - Mechanical Stimulation | Experimental | Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, mechanical stimulation |
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| Arm B - Massages | Sham Comparator | Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, massages. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical Stimulation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain level by a numerical scale | Pain level will be evaluated using a numerical scale of pain | 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. | 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. | 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. | 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Pain level by a numerical scale | Pain level will be evaluated using a numerical scale of pain | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia REGIS, MD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Lille | Hauts-de-France | 59020 | France | ||
| Centre Hospitalier Universitaire de Lille |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008405 | Massage |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Massages | Procedure | 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:
|
|
| 15 days after the end of physiotherapy |
| Pain level by using QDN4 questionnaire | Pain level will be evaluated using QDN4 questionnaire, which is a pain scale from 0 to 10. | 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. | 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:
| 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. | 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. | at the baseline and 6 months after |
| Lille |
| 59037 |
| France |
| D017437 |
| Skin and Connective Tissue Diseases |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |