Clinical trial NCT04202640: Mechanical Stimulation on Pain Level and Functional Discomfort After Breast Cancer Surgery
Official title: Effectiveness of Mechanical Stimulation on Pain Level and Functional Discomfort Following a Total Mastectomy and Exploratory Axillary Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Mechanical Stimulation
Mastectomy
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Pain level by a numerical scale
timeFrame: 6 months after randomization
measure: Pain level by using Brief Pain Inventory
timeFrame: 6 months after randomization
measure: Pain level by using QDN4 questionnaire
timeFrame: 6 months after randomization
measure: Mobility of the shoulders
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Pain level by a numerical scale
timeFrame: 15 days after the end of physiotherapy
measure: Pain level by using Brief Pain Inventory
timeFrame: 15 days after the end of physiotherapy
measure: Pain level by using QDN4 questionnaire
timeFrame: 15 days after the end of physiotherapy
measure: Mobility of the shoulders
timeFrame: 15 days after the end of physiotherapy
measure: Anxiety
timeFrame: at the baseline and 6 months after
measure: Quality of Life (QoL) with EORTC-QLQ-C30
timeFrame: at the baseline and 6 months after
measure: Quality of Life (QoL) with EORTC-QLQ-BR23
timeFrame: at the baseline and 6 months after
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
state: Hauts-de- France
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
Study officials:
affiliation: Centre Oscar Lambret
name: Claudia REGIS, MD
role: PRINCIPAL_INVESTIGATOR
References: