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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 4
- 主要终点
- evaluation of the benefit of prehabilitation with physiotherapy, including mechanostimulation, on shoulder pain and mobility, compared with standard care without prehabilitation.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Pregnant or breastfeeding women
研究组 & 干预措施
PREHAB arm
Prehabilitation with physiotherapy including mechanostimulation: a minimum of 6 and up to 8 sessions between inclusion and surgery, at a frequency of 2 sessions per week
干预措施: Prehabilitation with physiotherapy including mechanostimulation (Other)
STANDARD (Control) arm
No prehabilitation
干预措施: No Prehabilitation with physiotherapy including mechanostimulation (Other)
结局指标
主要结局
evaluation of the benefit of prehabilitation with physiotherapy, including mechanostimulation, on shoulder pain and mobility, compared with standard care without prehabilitation.
时间窗: 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.
次要结局
- Evaluation of the Forward flexion flexibility(at baseline, Day 30, and at Months 3, 6, and 12 post-surgery)
- 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 flexibility, height, vascularization, and pigmentation of the dorsal 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(at baseline, Day 30, and at Months 3, 6, and 12 post-surgery)
- Evaluation of the number of physiotherapy sessions with and without mechanostimulation(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(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(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(at Months 3, 6, and 12 post-surgery only)
