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

Conditions

• Breast Cancer
• Breast Reconstruction
• Latissimus Dorsi Flap
• Physiotherapy

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Prehabilitation with physiotherapy including mechanostimulation — OTHER
  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.
• No Prehabilitation with physiotherapy including mechanostimulation — OTHER
  No intervention

Study Details

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.

Key Dates

First listed

Feb 18, 2026

Start date

Aug 31, 2026

Status verified

Jun 2026

Primary completion

May 31, 2029

Completion

May 31, 2029

Study Design

Enrollment

72 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• 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
• Placebo Comparator: STANDARD (Control) arm
  No prehabilitation

Primary Outcome Measure

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 ]

Central Contacts

• Aurore MOUSSION
  0467613102
  [email protected]

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