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

NCT07418060 | Not Yet Recruiting

• 1 other identifier: PROICM 2025-08 PRE
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer; Physiotherapy; Breast Reconstruction; Latissimus Dorsi Flap

Outcome Measures

Primary Outcomes (1)

• 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.

  at Day 30 in patients undergoing breast reconstruction with a latissimus dorsi flap

Secondary Outcomes (11)

• Evaluation of the progression of 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

  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

  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

  at baseline, Day 30, and at Months 3, 6, and 12 post-surgery

• Evaluation of the Forward flexion flexibility

  at baseline, Day 30, and at Months 3, 6, and 12 post-surgery

Study Arms (2)

PREHAB arm

EXPERIMENTAL

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

STANDARD (Control) arm

PLACEBO COMPARATOR

No prehabilitation

Other: No Prehabilitation with physiotherapy including mechanostimulation

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.

PREHAB arm

No Prehabilitation with physiotherapy including mechanostimulation OTHER

No intervention

STANDARD (Control) arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (2)

Institut Bergonié

Bordeaux, Aquitaine, 33076, France

Location

Institut régional du Cancer de Montpellier

Montpellier, Herault, 34298, France

Location

Related Publications (17)

• Delay E, Gounot N, Bouillot A, Zlatoff P, Rivoire M. Autologous latissimus breast reconstruction: a 3-year clinical experience with 100 patients. Plast Reconstr Surg. 1998 Oct;102(5):1461-78. doi: 10.1097/00006534-199810000-00020.

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• Piat JM, Tomazzoni G, Giovinazzo V, Dubost V, Maiato AP, Ho Quoc C. Lipofilled Mini Dorsi Flap: An Efficient Less Invasive Concept for Immediate Breast Reconstruction. Ann Plast Surg. 2020 Oct;85(4):369-375. doi: 10.1097/SAP.0000000000002237.

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Related Links

• Reconstruction mammaire : la HAS et l'INCa présentent une plateforme d'aide à la décision partagée
• Stratégie décennale de lutte contre les cancers 2021-2030

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kerstin FARAVEL

  ICM Montpellier

  STUDY DIRECTOR

Central Study Contacts

Aurore MOUSSION

CONTACT

0467613102; drci-icm105@icm.unicancer.fr

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: February 3, 2026
• First Posted: February 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)