Breast CancerPREHAB KINELGDNCT07418060
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
A study testing Prehabilitation with physiotherapy including mechanostimulation and No Prehabilitation with physiotherapy including mechanostimulation in people with Breast Cancer and Physiotherapy, run by Institut du Cancer de Montpellier - Val d'Aurelle at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Physiotherapy, Breast Reconstruction
- What is being tested?
- Prehabilitation with physiotherapy including mechanostimulation and No Prehabilitation with physiotherapy including mechanostimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Aug 2026to Jul 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Institut Bergonié
Bordeaux, Aquitaine, 33076
Thibault LEROY-COCRELLE, 05 56 33 04 05 ext. +33, t.leroy-cocrelle@bordeaux.unicancer.fr
- Recruiting
Institut régional du Cancer de Montpellier
Montpellier, Herault, 34298
Kerstin FARAVEL, 0467612407 ext. +33, kerstin.faravel@icm.unicancer.fr
About this study
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
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.
Read more
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.
- Being tested
- Prehabilitation with physiotherapy including mechanostimulation, No Prehabilitation with physiotherapy including mechanostimulation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation with physiotherapy including mechanostimulationOther
a preoperative physiotherapy program including a minimum of 6 and up to 8 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 mechanostimulationOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| PREHAB arm | Experimental | 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 Receives: Other: Prehabilitation with physiotherapy including mechanostimulation |
| STANDARD (Control) arm | Placebo comparator | No prehabilitation Receives: Other: No Prehabilitation with physiotherapy including mechanostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at Day 30 in patients undergoing breast reconstruction with a latissimus dorsi flap
Secondary outcomes (11)
Evaluation of the progression of shoulder function
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.
Measured: at baseline and Months 3, 6, and 12 post-surgery
Evaluation of the changes in pain using the Numerical Rating Scale (NRS)/pain scale
Numerical Rating Scale (NRS) for pain The Numerical Rating Scale from 0 to 10, with 0 indicating no pain and 10 indicating maximal pain.
Measured: 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
"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.
Measured: 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
Goniometric measurements of shoulder flexion/extension, abduction/adduction, and internal/external rotation
Measured: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the Forward flexion flexibility
Finger-to-floor distance in cm
Measured: 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
Vancouver Scar Scale score. The score is between 0 and 13, with 0 for normal skin, and 13 for a very pathological scar
Measured: 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
Number of postoperative fluid aspirations and aspirated volume, recorded in the medical file
Measured: at baseline, Day 30, and at Months 3, 6, and 12 post-surgery
Evaluation of the number of physiotherapy sessions with and without mechanostimulation
Number of physiotherapy sessions with and without mechanostimulation
Measured: 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
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
Measured: 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
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.
Measured: 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
assessment of the time to return to work, expressed in weeks
Measured: at Months 3, 6, and 12 post-surgery only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start28 Aug 2026
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerstin FARAVEL, Study director, ICM Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418060
- Sponsor's protocol ID
- PROICM 2025-08 PRE
- Acronym
- PREHAB KINELGD
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
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.
PubMed 9774000Steffenssen 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.
PubMed 30516558Blackburn 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.
PubMed 28185324Piat 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.
PubMed 32032119Eyjolfsdottir 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.
PubMed 27369738Bruce 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.
PubMed 35220995Leung 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.
PubMed 36645966Humbert 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.
PubMed 25673979Gordon C, Emiliozzi C, Zartarian M. Use of a mechanical massage technique in the treatment of fibromyalgia: a preliminary study. Arch Phys Med Rehabil. 2006 Jan;87(1):145-7. doi: 10.1016/j.apmr.2005.08.125.
PubMed 16401454Razzouk K, Humbert P, Borens B, Gozzi M, Al Khori N, Pasquier J, Rafii Tabrizi A. Skin trophicity improvement by mechanotherapy for lipofilling-based breast reconstruction postradiation therapy. Breast J. 2020 Apr;26(4):725-728. doi: 10.1111/tbj.13645. Epub 2019 Oct 28.
PubMed 31659819Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
PubMed 3791738Constant CR, Gerber C, Emery RJ, Sojbjerg JO, Gohlke F, Boileau P. A review of the Constant score: modifications and guidelines for its use. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):355-61. doi: 10.1016/j.jse.2007.06.022. Epub 2008 Jan 22. No abstract available.
PubMed 18218327Fayad F, Lefevre-Colau MM, Mace Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Gautheron V, Revel M, Poiraudeau S. Validation of the French version of the Disability of the Arm, Shoulder and Hand questionnaire (F-DASH). Joint Bone Spine. 2008 Mar;75(2):195-200. doi: 10.1016/j.jbspin.2007.04.023. Epub 2007 Aug 30.
PubMed 17983829Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. doi: 10.1097/00004630-199005000-00014.
PubMed 2373734Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.
PubMed 20596233