About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient with pre-existing shoulder pathology (Constant score < 80/100)
Patient with uncontrolled psychiatric or mental disorders
Patient unable to understand French
Patient under guardianship or safeguard of justice
Trial design
Parallel
Treatments tested in this trial
Prehabilitation with physiotherapy including mechanostimulation
Other interventiona preoperative physiotherapy program including a minimum of 6 and up to 8 sessions, at a frequency of 2 sessions per week. These sessions may be performed in private practice or at the investigational center.
No Prehabilitation with physiotherapy including mechanostimulation
Other interventionNo intervention
Treatment groups
Trial outcomes
Primary outcomes
evaluation of the benefit of prehabilitation with physiotherapy, including mechanostimulation, on shoulder pain and mobility, compared with standard care without prehabilitation.
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.
Secondary outcomes
Evaluation of the progression of shoulder function
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.
Evaluation of the changes in pain using the Numerical Rating Scale (NRS)/pain scale
Numerical Rating Scale (NRS) for pain The Numerical Rating Scale from 0 to 10, with 0 indicating no pain and 10 indicating maximal pain.
Evaluation of the changes in disability and severity of symptoms in the operated-side shoulder
"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.
Evaluation of the changes in range of motion in the operated-side shoulder
Goniometric measurements of shoulder flexion/extension, abduction/adduction, and internal/external rotation
Sponsors and contacts
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