Prevention of Sequelae Pain After Breast Cancer Surgery by Self-massages and Self Stretching. Impact of Learning Workshops. (ESTAUVAL)
Prevention of Sequelae Pain After Breast Cancer Surgery by Daily Self Massages and Self Stretching of Serratus Anterior Muscle, Pectoralis Major Muscle, Infraspinatus Muscle and Latissimus Dorsi Muscle: Impact of Learning Workshops Performed by a Multidisciplinary Team.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rennes, France, 35042
- Centre Eugène Marquis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Other: Without learning workshops
Standard follow-up.
Patients randomized in this arm won't attend Learning workshops and will be followed in a standard way.
|
Patients enrolled into standard group will be followed in a standard way without any additional procedure except randomization that allocates to the standard group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of Learning workshops (self massages and self stretching) on sequelae pain after breast cancer surgery
Time Frame: For 12 months after surgery
|
Number of patients with chronic pain
|
For 12 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of patient quality of life
Time Frame: at 3, 6 and 12 months
|
Assessed by EORTC Quality of Life Questionnaire Core questionnaire 30 scale
|
at 3, 6 and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aurélie THEBAULT, Centre Eugène Marquis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-4-6-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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