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

Centre Oscar Lambret

Status: Terminated

Conditions: Breast Cancer

Treatments: Procedure: Mechanical Stimulation; Procedure: Massages

Study type: Interventional

Funder types: Other

Identifiers

NCT04202640

PRESSODOU-1809

Details and patient eligibility

About

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.

Full description

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

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Arm A - Mechanical Stimulation

Experimental group

Description:

Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, mechanical stimulation

Treatment:

Procedure: Mechanical Stimulation

Arm B - Massages

Sham Comparator group

Description:

Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, massages.

Treatment:

Procedure: Massages