Prevention of Sequelae Pain After Breast Cancer Surgery by Self-massages and Self Stretching. Impact of Learning Workshops. (ESTAUVAL)

Center Eugene Marquis

Status: Active, not recruiting

Conditions: Breast Cancer; Surgery

Treatments: Other: Standard follow-up; Other: Learning workshops

Study type: Interventional

Funder types: Other

Identifiers

NCT03651973

2015-4-6-003

Details and patient eligibility

About

Myofascial pain syndrome is a common cause of chronic pain characterized by myofascial pain and trigger points. Recommendations regarding management of pain after breast cancer don't mention myofascial syndrome despite a study suggests possible myofascial syndrome with roughly 75% of patients in pain.

144 patients having a local breast cancer requiring surgery will be randomized in this study, ratio 1:1 standard and experimental groups.

Every patients (standard and experimental groups) will attend 4 specific consultations during which standard recommendations will be given, pain, quality of life, shoulder range of motion, global upper limbs force will be assessed.

In addition, patient randomized in experimental group will attend self massages and self stretching workshops, one before surgery and one after surgery. Patients will be encouraged to performed daily self massages and self stretching.

The aim of the study is to assess impact of self massages and self stretching workshops on sequelae pain further surgery for breast cancer.

Enrollment: 143 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Woman
• Local development of breast cancer, every stages except stage IV
• Indication of surgery whatever surgery type except breast reconstruction
• More than18 years
• Life expectancy > 12 months assessed by surgeon or pain specialist
• Informed and written consent
• Affiliated to a social security system

Exclusion criteria

• History of chronic pain
• History of shoulder pain
• Any illness or severe disease, medical or psychiatric, that could prevent the patient to follow study procedures or to give her informed consent, according investigators,
• History of breast surgery
• Pregnant or lactating woman
• Protected adult or deprived of her liberty

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

With learning workshops

Experimental group

Description:

Patients in experimental arm will attend learning workshops, one before breast cancer surgey and one after surgery. Patients will be educated by physiologist to self massages and self stretching. Each workshop will last around 2 hours.

Treatment:

Other: Learning workshops

Without learning workshops

Other group

Description:

Standard follow-up. Patients randomized in this arm won't attend Learning workshops and will be followed in a standard way.

Treatment:

Other: Standard follow-up