Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:35 AM
Study NCT ID:
NCT07418060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082622', 'term': 'Preoperative Exercise'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation of the benefit of prehabilitation with physiotherapy, including mechanostimulation, on shoulder pain and mobility, compared with standard care without prehabilitation.', 'timeFrame': 'at Day 30 in patients undergoing breast reconstruction with a latissimus dorsi flap', 'description': '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.\n\nThe Constant score ranges from 0 to 100, with 0 indicating near-total loss of function and 100 indicating normal shoulder function.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the progression of shoulder function', 'timeFrame': 'at baseline and Months 3, 6, and 12 post-surgery', 'description': '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.\n\nThe Constant score ranges from 0 to 100, with 0 indicating near-total loss of function and 100 indicating normal shoulder function.'}, {'measure': 'Evaluation of the changes in pain using the Numerical Rating Scale (NRS)/pain scale', 'timeFrame': 'at baseline, Day 30, and at Months 3, 6, and 12 post-surgery', 'description': 'Numerical Rating Scale (NRS) for pain The Numerical Rating Scale from 0 to 10, with 0 indicating no pain and 10 indicating maximal pain.'}, {'measure': 'Evaluation of the changes in disability and severity of symptoms in the operated-side shoulder', 'timeFrame': 'at baseline, Day 30, and at Months 3, 6, and 12 post-surgery', 'description': '"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.'}, {'measure': 'Evaluation of the changes in range of motion in the operated-side shoulder', 'timeFrame': 'at baseline, Day 30, and at Months 3, 6, and 12 post-surgery', 'description': 'Goniometric measurements of shoulder flexion/extension, abduction/adduction, and internal/external rotation'}, {'measure': 'Evaluation of the Forward flexion flexibility', 'timeFrame': 'at baseline, Day 30, and at Months 3, 6, and 12 post-surgery', 'description': 'Finger-to-floor distance in cm'}, {'measure': 'Evaluation of the flexibility, height, vascularization, and pigmentation of the dorsal scar', 'timeFrame': 'at baseline, Day 30, and at Months 3, 6, and 12 post-surgery', 'description': 'Vancouver Scar Scale score. The score is between 0 and 13, with 0 for normal skin, and 13 for a very pathological scar'}, {'measure': 'Evaluation of the number of lymphatic fluid aspirations and the aspirated volume in the postoperative period', 'timeFrame': 'at baseline, Day 30, and at Months 3, 6, and 12 post-surgery', 'description': 'Number of postoperative fluid aspirations and aspirated volume, recorded in the medical file'}, {'measure': 'Evaluation of the number of physiotherapy sessions with and without mechanostimulation', 'timeFrame': 'at baseline, Day 30, and at Months 3, 6, and 12 post-surgery', 'description': 'Number of physiotherapy sessions with and without mechanostimulation'}, {'measure': 'Evaluation of the changes in quality of life by Quality of Life Questionnaire', 'timeFrame': 'at baseline, Day 30, and at Months 3, 6, and 12 post-surgery', 'description': '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'}, {'measure': 'Evaluation of the changes in quality of life according of Quality of Life Questionnaire specify for Breast Cancer', 'timeFrame': 'at baseline, Day 30, and at Months 3, 6, and 12 post-surgery', 'description': '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.'}, {'measure': 'Evaluation of the return to work, measured by the number of weeks before resuming employment', 'timeFrame': 'at Months 3, 6, and 12 post-surgery only', 'description': 'assessment of the time to return to work, expressed in weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Physiotherapy', 'Breast Reconstruction', 'Latissimus Dorsi Flap']}, 'referencesModule': {'references': [{'pmid': '9774000', 'type': 'BACKGROUND', 'citation': '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': '30516558', 'type': 'BACKGROUND', 'citation': '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': '28185324', 'type': 'BACKGROUND', 'citation': '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': '32032119', 'type': 'BACKGROUND', 'citation': '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': '27369738', 'type': 'BACKGROUND', 'citation': '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': '35220995', 'type': 'BACKGROUND', 'citation': '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': '36645966', 'type': 'BACKGROUND', 'citation': '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': '25673979', 'type': 'BACKGROUND', 'citation': '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': '16401454', 'type': 'BACKGROUND', 'citation': 'Gordon 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.'}, {'pmid': '31659819', 'type': 'BACKGROUND', 'citation': 'Razzouk 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.'}, {'pmid': '3791738', 'type': 'BACKGROUND', 'citation': 'Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.'}, {'pmid': '18218327', 'type': 'BACKGROUND', 'citation': 'Constant 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.'}, {'pmid': '17983829', 'type': 'BACKGROUND', 'citation': 'Fayad 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.'}, {'pmid': '2373734', 'type': 'BACKGROUND', 'citation': 'Sullivan 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.'}, {'pmid': '20596233', 'type': 'BACKGROUND', 'citation': 'Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.'}, {'pmid': '31318747', 'type': 'BACKGROUND', 'citation': 'Dabija DI, Jain NB. Minimal Clinically Important Difference of Shoulder Outcome Measures and Diagnoses: A Systematic Review. Am J Phys Med Rehabil. 2019 Aug;98(8):671-676. doi: 10.1097/PHM.0000000000001169.'}, {'pmid': '19276275', 'type': 'BACKGROUND', 'citation': 'Rubinstein L, Crowley J, Ivy P, Leblanc M, Sargent D. Randomized phase II designs. Clin Cancer Res. 2009 Mar 15;15(6):1883-90. doi: 10.1158/1078-0432.CCR-08-2031. Epub 2009 Mar 10.'}], 'seeAlsoLinks': [{'url': 'https://www.has-sante.fr/jcms/p_3424113/fr/reconstruction-mammaire-la-has-et-l-inca-presentent-une-plateforme-d-aide-a-la-decision-partagee', 'label': "Reconstruction mammaire : la HAS et l'INCa présentent une plateforme d'aide à la décision partagée"}, {'url': 'https://www.cancer.fr/l-institut-national-du-cancer/la-strategie-de-lutte-contre-les-cancers-en-france/strategie-decennale-de-lutte-contre-les-cancers-2021-2030', 'label': 'Stratégie décennale de lutte contre les cancers 2021-2030'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nA 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%.\n\nIn view of these findings, preventing pain and functional impairment has become a key research focus to improve patients' quality of life.\n\nPostoperative 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.\n\nPrehabilitation, 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.\n\nThe 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.\n\nAdditionally, 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patient aged 18 years or older\n* Scheduled for breast reconstruction with a latissimus dorsi flap following breast cancer\n* Patient has been informed and has signed the informed consent form\n* Affiliated with a social security system\n\nExclusion Criteria:\n\n* Patient with pre-existing shoulder pathology (Constant score \\< 80/100)\n* Patient with uncontrolled psychiatric or mental disorders\n* Patient unable to understand French'}, 'identificationModule': {'nctId': 'NCT07418060', 'acronym': 'PREHAB KINELGD', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PROICM 2025-08 PRE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PREHAB arm', 'description': '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', 'interventionNames': ['Other: Prehabilitation with physiotherapy including mechanostimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'STANDARD (Control) arm', 'description': 'No prehabilitation', 'interventionNames': ['Other: No Prehabilitation with physiotherapy including mechanostimulation']}], 'interventions': [{'name': 'Prehabilitation with physiotherapy including mechanostimulation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['PREHAB arm']}, {'name': 'No Prehabilitation with physiotherapy including mechanostimulation', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['STANDARD (Control) arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'state': 'Aquitaine', 'country': 'France', 'contacts': [{'name': 'Thibault LEROY-COCRELLE', 'role': 'CONTACT', 'email': 't.leroy-cocrelle@bordeaux.unicancer.fr', 'phone': '05 56 33 04 05', 'phoneExt': '+33'}], 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '34298', 'city': 'Montpellier', 'state': 'Herault', 'country': 'France', 'contacts': [{'name': 'Kerstin FARAVEL', 'role': 'CONTACT', 'email': 'kerstin.faravel@icm.unicancer.fr', 'phone': '0467612407', 'phoneExt': '+33'}], 'facility': 'Institut régional du Cancer de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Aurore MOUSSION', 'role': 'CONTACT', 'email': 'drci-icm105@icm.unicancer.fr', 'phone': '0467613102'}], 'overallOfficials': [{'name': 'Kerstin FARAVEL', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ICM Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}