Evaluation of the Impact of Pre-habilitation Using Physiotherapy and Mechanical Stimulation on Shoulder Pain and Mobility in Patients Undergoing Breast Reconstruction Using a Latissimus Dorsi Flap (PREHAB KINELGD)

June 2, 2026 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Randomized, Multicentre Study Evaluating the Impact of Pre-habilitation Using Physiotherapy and Mechanical Stimulation on Shoulder Pain and Mobility in Patients Undergoing Breast Reconstruction Using a Latissimus Dorsi Flap

Each year in France, nearly 59,000 new cases of breast cancer are diagnosed, and approximately 22,000 mastectomies are performed. Among these patients, 30% choose to undergo breast reconstruction. Breast cancer leads to numerous physical and psychological changes. The need to strengthen patient support around breast reconstruction has been highlighted, and it is one of the priorities of the national Ten-Year Cancer Control Strategy. The growing number of patients living after cancer makes the management of post-treatment sequelae essential.

The rate of reconstruction is increasing thanks to improvements in technique and better access to information. Among the available options, the latissimus dorsi (LD) flap has been a standard technique for immediate and delayed breast reconstruction for over 25 years. The LD technique offers several advantages: high reliability, feasibility even in irradiated thoraxes, low rates of postoperative complications, and satisfactory aesthetic outcomes. Its versatility and reliability have made it a cornerstone of breast surgery. However, this technique can lead to short- and long-term functional sequelae, which persist in 10% of patients. To reduce these side effects, an optimized version-the lipofilled mini-latissimus dorsi flap (mLD)-was developed by a team in Strasbourg. This quicker and less muscle-invasive technique is mainly used for immediate reconstruction or to replace implant-based reconstruction, with systematic lipofilling. However, no objective functional assessment of this method has yet been carried out, justifying a stratification according to the type of procedure for randomization in future studies. According to a prospective Icelandic study involving 15 patients, full recovery can be expected, but patients must be informed of the time and effort required to achieve it. The authors also concluded that further research is necessary to better understand the limits of long-term recovery.

A study of 450 LD reconstructions showed that pain and the main functional sequelae were located in the back and shoulder, with 10% of patients experiencing significant long-term pain. In addition, according to this study, around 40% of patients consider postoperative sequelae and scarring burdensome. However, regret rates remain low, at under 3%.

In view of these findings, preventing pain and functional impairment has become a key research focus to improve patients' quality of life.

Postoperative rehabilitation plays a crucial role in managing pain, reducing functional impairment, and optimizing aesthetic outcomes. The addition of mechanostimulation (MS) has been shown to improve scar appearance, shoulder function, and functional well-being compared with rehabilitation alone. MS is delivered using a device equipped with motorized rollers and suction to mobilize tissues. In physiotherapy, it helps relieve pain and improve mobility.

Prehabilitation, a rapidly expanding concept in surgery, aims to prepare patients before their procedure. However, to date, no prehabilitation approach combining physiotherapy and MS has been considered prior to LD flap surgery. One study highlighted improved tissue trophicity after tissue preparation with MS before lipomodelling.

The objective of our study is to evaluate the benefit of prehabilitation through physiotherapy incorporating MS to prepare tissues (in particular skin and muscle) on shoulder pain and functional outcomes in patients undergoing breast reconstruction with a latissimus dorsi flap.

Additionally, due to the heterogeneity and sometimes limited access to specialized postoperative physiotherapy, extensive patient follow-up has been planned in order to describe, on an exploratory basis, real-world rehabilitation practices.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patient aged 18 years or older
  • Scheduled for breast reconstruction with a latissimus dorsi flap following breast cancer
  • Patient has been informed and has signed the informed consent form
  • Affiliated with a social security system

Exclusion Criteria:

  • Patient with pre-existing shoulder pathology (Constant score < 80/100)
  • Patient with uncontrolled psychiatric or mental disorders
  • Patient unable to understand French

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: PREHAB arm
Prehabilitation with physiotherapy including mechanostimulation: a minimum of 4 and up to 10 sessions between inclusion and surgery, at a frequency of 2 sessions per week
Other: Prehabilitation with physiotherapy including mechanostimulation
a preoperative physiotherapy program including a minimum of 4 and up to 10 sessions, at a frequency of 2 sessions per week. These sessions may be performed in private practice or at the investigational center.
Placebo Comparator: STANDARD (Control) arm
No prehabilitation
Other: No Prehabilitation with physiotherapy including mechanostimulation
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of the benefit of prehabilitation with physiotherapy, including mechanostimulation, on shoulder pain and mobility, compared with standard care without prehabilitation.
Time Frame: at Day 30 in patients undergoing breast reconstruction with a latissimus dorsi flap

Constant score assessed at Day 30 post-surgery. Note: The Constant score evaluates the shoulder across four dimensions: 1) Pain, 2) Shoulder function, 3) Active range of motion of the shoulder, and 4) Muscle strength.

The Constant score ranges from 0 to 100, with 0 indicating near-total loss of function and 100 indicating normal shoulder function.
at Day 30 in patients undergoing breast reconstruction with a latissimus dorsi flap

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the progression of shoulder function
Time Frame: at baseline and Months 3, 6, and 12 post-surgery

constant score Note: The Constant score evaluates the shoulder across four dimensions: 1) Pain, 2) Shoulder function, 3) Active range of motion of the shoulder, and 4) Muscle strength.

The Constant score ranges from 0 to 100, with 0 indicating near-total loss of function and 100 indicating normal shoulder function.
at baseline and Months 3, 6, and 12 post-surgery
Evaluation of the changes in pain using the Numerical Rating Scale (NRS)/pain scale
Time Frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Numerical Rating Scale (NRS) for pain The Numerical Rating Scale from 0 to 10, with 0 indicating no pain and 10 indicating maximal pain.
at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the changes in disability and severity of symptoms in the operated-side shoulder
Time Frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
"Disabilities of the Arm, Shoulder, and Hand" questionnaire score (DASH) DASH questionnaire Scale from 0 to 100, with 0 indicating no disability and 100 indicating total disability.
at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the changes in range of motion in the operated-side shoulder
Time Frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Goniometric measurements of shoulder flexion/extension, abduction/adduction, and internal/external rotation
at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the Forward flexion flexibility
Time Frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Finger-to-floor distance in cm
at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the flexibility, height, vascularization, and pigmentation of the dorsal scar
Time Frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Vancouver Scar Scale score. The score is between 0 and 13, with 0 for normal skin, and 13 for a very pathological scar
at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the number of lymphatic fluid aspirations and the aspirated volume in the postoperative period
Time Frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Number of postoperative fluid aspirations and aspirated volume, recorded in the medical file
at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the number of physiotherapy sessions with and without mechanostimulation
Time Frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Number of physiotherapy sessions with and without mechanostimulation
at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the return to work, measured by the number of weeks before resuming employment
Time Frame: at Months 3, 6, and 12 post-surgery only
assessment of the time to return to work, expressed in weeks
at Months 3, 6, and 12 post-surgery only
Evaluation of the changes in quality of life by Quality of Life Questionnaire
Time Frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Quality of life will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30). All scale scores are linearly transformed to a 0-100 scale. Higher scores on functional scales indicate better functioning, whereas higher scores on symptom scales indicate worse symptoms
at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the changes in quality of life according of Quality of Life Questionnaire specify for Breast Cancer
Time Frame: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR42). Scores for each scale are linearly transformed to a 0-100 scale. Higher scores on functional scales indicate better functioning, whereas higher scores on symptom scales indicate worse symptoms.
at baseline, Day 30, and at Months 3, 6, and 12 post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Director: Kerstin FARAVEL, ICM Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2025-08 PRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.

IPD Sharing Time Frame

Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.

IPD Sharing Access Criteria

The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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