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NCT Number: NCT07418060

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonié, Bordeaux, Aquitaine, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

    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

  1. Evaluation of the progression of shoulder function

    Time frame: at baseline and Months 3, 6, and 12 post-surgery

    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.

  2. 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

    Numerical Rating Scale (NRS) for pain The Numerical Rating Scale from 0 to 10, with 0 indicating no pain and 10 indicating maximal pain.

  3. 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

    "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.

  4. 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

    Goniometric measurements of shoulder flexion/extension, abduction/adduction, and internal/external rotation

  5. Evaluation of the Forward flexion flexibility

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

    Finger-to-floor distance in cm

  6. 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

    Vancouver Scar Scale score. The score is between 0 and 13, with 0 for normal skin, and 13 for a very pathological scar

  7. 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

    Number of postoperative fluid aspirations and aspirated volume, recorded in the medical file

  8. 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

    Number of physiotherapy sessions with and without mechanostimulation

  9. 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

    Quality of life will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30). All scale scores are linearly transformed to a 0-100 scale. Higher scores on functional scales indicate better functioning, whereas higher scores on symptom scales indicate worse symptoms

  10. 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

    Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR42). Scores for each scale are linearly transformed to a 0-100 scale. Higher scores on functional scales indicate better functioning, whereas higher scores on symptom scales indicate worse symptoms.

  11. 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

    assessment of the time to return to work, expressed in weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore MOUSSION

CONTACT

[email protected]

0467613102

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study 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

Acronym: PREHAB KINELGD

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 18, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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