Mechanical Stimulation on Pain Level and Functional Discomfort After Breast Cancer Surgery
NCT ID: NCT04202640
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
80 participants
INTERVENTIONAL
2020-05-27
2023-12-07
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm A - Mechanical Stimulation
Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, mechanical stimulation
Mechanical Stimulation
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.
Arm B - Massages
Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, massages.
Massages
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)
Interventions
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Mechanical Stimulation
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
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Total bilateral mastectomy
* Contraindication to mechanical stimulation technique
* Patient who are planning to move houses in the next 6 months
* Patients under guardianship
18 Years
FEMALE
No
Sponsors
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Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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Claudia REGIS, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Oscar Lambret
Locations
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Centre Oscar Lambret
Lille, Hauts-de-France, France
Centre Hospitalier Universitaire de Lille
Lille, , France
Countries
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Other Identifiers
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PRESSODOU-1809
Identifier Type: -
Identifier Source: org_study_id
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