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

Not Applicable

Recruiting

• Conditions: Breast Cancer; Surgery
• Interventions: Other: Learning workshops; Other: Standard follow-up

• Registration Number: NCT03651973
• Lead Sponsor: Center Eugene Marquis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-29
• Study Start: 2020-01-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 144

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With learning workshops	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.
Without learning workshops	Standard follow-up	Standard follow-up. Patients randomized in this arm won't attend Learning workshops and will be followed in a standard way.

Primary Outcome Measures

Name	Time	Method
Impact of Learning workshops (self massages and self stretching) on sequelae pain after breast cancer surgery	For 12 months after surgery	Number of patients with chronic pain

Secondary Outcome Measures

Name	Time	Method
Impact of patient quality of life	at 3, 6 and 12 months	Assessed by EORTC Quality of Life Questionnaire Core questionnaire 30 scale

Trial Locations

Locations (1)

Centre Eugène Marquis; 🇫🇷 Rennes, France