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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04202640
• Other study ID #: PRESSODOU-1809
• Status: Terminated
• Phase: N/A
• Start date: May 27, 2020
• Est. completion date: December 7, 2023

Study information

• Verified date: December 2023
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: December 7, 2023
• Est. primary completion date: December 7, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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)

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Lille	Lille
France	Centre Oscar Lambret	Lille	Hauts-de- France

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level by a numerical scale	Pain level will be evaluated using a numerical scale of pain	6 months after randomization
Primary	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
Primary	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
Primary	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	Pain level by a numerical scale	Pain level will be evaluated using a numerical scale of pain	15 days after the end of physiotherapy
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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