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

Official title

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

Overview

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.

Interventions

• 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.
• Other No Prehabilitation with physiotherapy including mechanostimulation
  No intervention

Primary outcome measures

• 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]

Secondary outcome measures (11)

• Evaluation of the progression of shoulder function [Time frame: 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]
• 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]
• 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]
• Evaluation of the Forward flexion flexibility [Time frame: 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]
• 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]
• 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]
• 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]
• 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]
• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

France · 2 centers

• Institut Bergonié — Bordeaux
• Institut régional du Cancer de Montpellier — Montpellier

Publications

• 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. PMID 9774000
• Steffenssen MCW, Kristiansen AH, Damsgaard TE. A Systematic Review and Meta-analysis of Functional Shoulder Impairment After Latissimus Dorsi Breast Reconstruction. Ann Plast Surg. 2019 Jan;82(1):116-127. doi: 10.1097/SAP.0000000000001691. PMID 30516558
• Blackburn NE, Mc Veigh JG, Mc Caughan E, Wilson IM. The musculoskeletal consequences of breast reconstruction using the latissimus dorsi muscle for women following mastectomy for breast cancer: A critical review. Eur J Cancer Care (Engl). 2018 Mar;27(2):e12664. doi: 10.1111/ecc.12664. Epub 2017 Feb 10. PMID 28185324
• 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. PMID 32032119
• Eyjolfsdottir H, Haraldsdottir B, Ragnarsdottir M, Asgeirsson KS. A Prospective Analysis on Functional Outcomes Following Extended Latissimus Dorsi Flap Breast Reconstruction. Scand J Surg. 2017 Jun;106(2):152-157. doi: 10.1177/1457496916655500. Epub 2016 Jul 1. PMID 27369738
• Bruce J, Mazuquin B, Mistry P, Rees S, Canaway A, Hossain A, Williamson E, Padfield EJ, Lall R, Richmond H, Chowdhury L, Lait C, Petrou S, Booth K, Lamb SE, Vidya R, Thompson AM. Exercise to prevent shoulder problems after breast cancer surgery: the PROSPER RCT. Health Technol Assess. 2022 Feb;26(15):1-124. doi: 10.3310/JKNZ2003. PMID 35220995
• Leung AKP, Ouyang H, Pang MYC. Effects of mechanical stimulation on mastectomy scars within 2 months of surgery: A single-center, single-blinded, randomized controlled trial. Ann Phys Rehabil Med. 2023 Jun;66(5):101724. doi: 10.1016/j.rehab.2022.101724. Epub 2023 Jan 14. PMID 36645966
• Humbert P, Fanian F, Lihoreau T, Jeudy A, Elkhyat A, Robin S, Courderot-Masuyer C, Tauzin H, Lafforgue C, Haftek M. Mecano-Stimulation of the skin improves sagging score and induces beneficial functional modification of the fibroblasts: clinical, biological, and histological evaluations. Clin Interv Aging. 2015 Feb 2;10:387-403. doi: 10.2147/CIA.S69752. eCollection 2015. PMID 25673979

Identifiers

NCT: NCT07418060 · PROICM 2025-08 PRE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗