Mechanical Stimulation on Pain Level and Functional Discomfort After Breast Cancer Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effectiveness of Mechanical Stimulation on Pain Level and Functional Discomfort Following a Total Mastectomy and Exploratory Axillary Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Mechanical Stimulation
* Procedure: Massages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Patient who had total mastectomy for a breast cancer or pre-cancerous lesions Associated with axillary dissection or removal of the sentinel lymph nodes Presenting with functional discomfort and/or pain at the control consultation, 3 weeks after the mastectomy and justifying the prescription of physiotherapy Possibility to be treated by a physiotherapist who can carry out both techniques and accepts to perform either one of the techniques according to the randomized allocation of the treatment Patient covered by the French social security regime Signed and informed consent Exclusion Criteria: Immediate breast reconstruction Total bilateral mastectomy Contraindication to mechanical stimulation technique Patient who are planning to move houses in the next 6 months Patients under guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A - Mechanical Stimulation<br>Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, mechanical stimulation | Procedure: Mechanical Stimulation<br>* 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.<br>|
| Sham Comparator: Arm B - Massages<br>Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, massages. | Procedure: Massages<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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: 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Mechanical Stimulation, Mastectomy