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

NCT ID: NCT03651973

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Breast Cancer; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

With learning workshops

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.

Group Type: EXPERIMENTAL

Learning workshops

Intervention Type: OTHER

Patients enrolled into experimental arm will participate to educative workshops before and after surgery for breast cancer. The aim of these workshop is to educate patient to self massages and self stretching.

Without learning workshops

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

Group Type: OTHER

Standard follow-up

Intervention Type: OTHER

Patients enrolled into standard group will be followed in a standard way without any additional procedure except randomization that allocates to the standard group

Interventions

Standard follow-up

Patients enrolled into standard group will be followed in a standard way without any additional procedure except randomization that allocates to the standard group

Intervention Type: OTHER

Learning workshops

Patients enrolled into experimental arm will participate to educative workshops before and after surgery for breast cancer. The aim of these workshop is to educate patient to self massages and self stretching.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Center Eugene Marquis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurélie THEBAULT

Role: PRINCIPAL_INVESTIGATOR

Centre Eugène Marquis

Locations

Centre Eugène Marquis

Rennes, , France

Countries

France

Other Identifiers

2015-4-6-003

Identifier Type: -

Identifier Source: org_study_id