NCT03651973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2025

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

5.7 years

First QC Date

July 4, 2018

Last Update Submit

March 17, 2026

Conditions

Keywords

Self massages and self stretchingWorkshops for self massages and stretching learning

Outcome Measures

Primary Outcomes (1)

  • Impact of Learning workshops (self massages and self stretching) on sequelae pain after breast cancer surgery

    Number of patients with chronic pain

    For 12 months after surgery

Secondary Outcomes (1)

  • Impact of patient quality of life

    at 3, 6 and 12 months

Study Arms (2)

With learning workshops

EXPERIMENTAL

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.

Other: Learning workshops

Without learning workshops

OTHER

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

Other: Standard follow-up

Interventions

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.

With learning workshops

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

Without learning workshops

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Eugène Marquis

Rennes, 35042, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Aurélie THEBAULT

    Centre Eugène Marquis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2018

First Posted

August 29, 2018

Study Start

January 13, 2020

Primary Completion

September 25, 2025

Study Completion

September 25, 2025

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations