Mechanical Stimulation on Pain Level and Functional Discomfort After Breast Cancer Surgery

Effectiveness of Mechanical Stimulation on Pain Level and Functional Discomfort Following a Total Mastectomy and Exploratory Axillary Surgery

This study evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months, in breast cancer needing physiotherapy, following a total mastectomy and exploratory axillary surgery.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Mechanical Stimulation; Procedure: Massages

Detailed Description

A prospective, monocentric, randomized, open-labelled in two parallel groups study that evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months in breast cancer patients needing physiotherapy, following a total mastectomy and exploratory axillary surgery.

Other objectives of the study include:

• Evaluate the efficacy of mechanical stimulation technique compared to massages on pain and functional discomfort (on the mobility of the shoulder) 15 days after the end of physiotherapy.
• Evaluate the impact of mechanical stimulation on the quality of life of patients, in comparison to those receiving massages

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fanny BEN OUNE; Phone Number: +33 (0)3 20 29 59 18; Email: promotion@o-lambret.fr

Study Locations

• France
  • Lille, France, 59037
    • Centre Hospitalier Universitaire de Lille
  • Hauts-de- France
    • Lille, Hauts-de- France, France, 59020
      • Centre Oscar Lambret

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 18 years
• Patient who had total mastectomy for a breast cancer or pre-cancerous lesions
• Associated with axillary dissection or removal of the sentinel lymph nodes
• Presenting with functional discomfort and/or pain at the control consultation, 3 weeks after the mastectomy and justifying the prescription of physiotherapy
• Possibility to be treated by a physiotherapist who can carry out both techniques and accepts to perform either one of the techniques according to the randomized allocation of the treatment
• Patient covered by the French social security regime
• Signed and informed consent

Exclusion Criteria:

• Immediate breast reconstruction
• Total bilateral mastectomy
• Contraindication to mechanical stimulation technique
• Patient who are planning to move houses in the next 6 months
• Patients under guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A - Mechanical Stimulation; Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, mechanical stimulation	Procedure: Mechanical Stimulation; The technique of mechanical stimulation alternates between compression and decompression of the treated area. It aims to reestablish a good blood circulation and lymphatic drainage.
Sham Comparator: Arm B - Massages; Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, massages.	Procedure: Massages; Massages will be carried out according to a specific regime as specified in the study protocol. The massages will be done in 15 sessions of 30 minutes each, done twice a week and will consist of: One part muscle exercise; One part skin work (drainage)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level by a numerical scale	Pain level will be evaluated using a numerical scale of pain	6 months after randomization
Pain level by using Brief Pain Inventory	Pain level will be evaluated using Brief Pain Inventory (BPI), there is no global score for this questionnaire, each item must be considered separately.	6 months after randomization
Pain level by using QDN4 questionnaire	Pain level will be evaluated using QDN4 questionnaire, which is a pain scale from 0 to 10.	6 months after randomization
Mobility of the shoulders	Will be evaluated using the Constant score based on the study by Constant CR, Murley AHG. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987;(214):160-4. Pain level, level of daily activities and physical mobility will be assessed with a a scale adapted according to the gender and the patients age.	6 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level by a numerical scale	Pain level will be evaluated using a numerical scale of pain	15 days after the end of physiotherapy
Pain level by using Brief Pain Inventory	Pain level will be evaluated using Brief Pain Inventory (BPI), there is no global score for this questionnaire, each item must be considered separately.	15 days after the end of physiotherapy
Pain level by using QDN4 questionnaire	Pain level will be evaluated using QDN4 questionnaire, which is a pain scale from 0 to 10.	15 days after the end of physiotherapy
Mobility of the shoulders	Will be evaluated using the Constant score based on the study by Constant CR, Murley AHG. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987;(214):160-4. Pain level, level of daily activities and physical mobility will be assessed with a a scale adapted according to the gender and the patients age.	15 days after the end of physiotherapy
Anxiety	Will be evaluated using the Hospital Anxiety and Depression Scale (HADS) questionnaire. The questionnaire consists of a list of questions to determine the level of anxiety and depression experienced by the patients. Each question is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression: A score equal to or less than 7 indicates no symptoms,; A score of 8 - 10 indicates a questionable symptoms,; A score of 11 and above confirms of the presence of anxiety and/or depression symptoms	at the baseline and 6 months after
Quality of Life (QoL) with EORTC-QLQ-C30	Will be evaluated using the EORTC-QLQ-C30 questionnaire. This questionnaire aim to assess the quality of life of cancer. It is composed of 30 questions. In this questionnaire, the items are scored from 1-4, where 1 = not at all, 2 = a little, 3 = quite a bit and 4 = very much. Only 2 items in the EORTC-QLQ-C30 questionnaire are scored from 1-7, where 1 is very poor and 7 is excellent.	at the baseline and 6 months after
Quality of Life (QoL) with EORTC-QLQ-BR23	Will be evaluated using the EORTC-QLQ-BR23 questionnaire. This questionnaire aim to assess the quality of life of cancer. It is composed of 23 questions. In this questionnaire, the items are scored from 1-4, where 1 = not at all, 2 = a little, 3 = quite a bit and 4 = very much.	at the baseline and 6 months after

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Investigators: Principal Investigator: Claudia REGIS, MD, Centre Oscar Lambret

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2020
• Primary Completion (Actual): December 7, 2023
• Study Completion (Actual): December 7, 2023

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer; Mastectomy; Mechanical Stimulation
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PRESSODOU-1809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No