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

NCT04202640 | Terminated

• 2 other identifiers: PRESSODOU-18092019-A02377-50
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Mechanical Stimulation; Mastectomy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Pain level by a numerical scale

  15 days after the end of physiotherapy

• Pain level by using Brief Pain Inventory

  15 days after the end of physiotherapy

• Pain level by using QDN4 questionnaire

  15 days after the end of physiotherapy

• Mobility of the shoulders

  15 days after the end of physiotherapy

• Anxiety

  at the baseline and 6 months after

Study Arms (2)

Arm A - Mechanical Stimulation

EXPERIMENTAL

Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, mechanical stimulation

Procedure: Mechanical Stimulation

Arm B - Massages

SHAM COMPARATOR

Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, massages.

Procedure: Massages

Interventions

Massages PROCEDURE

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)

Arm B - Massages

Mechanical Stimulation PROCEDURE

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.

Arm A - Mechanical Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (2)

Centre Oscar Lambret

Lille, Hauts-de-France, 59020, France

Location

Centre Hospitalier Universitaire de Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Massage

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Claudia REGIS, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: December 17, 2019
• Study Start: May 27, 2020
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)