Breast CancerPRESSODOUNCT04202640
Mechanical Stimulation on Pain Level and Functional Discomfort After Breast Cancer Surgery
A study testing Mechanical Stimulation and Massages in people with Breast Cancer, run by Centre Oscar Lambret at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mechanical Stimulation and Massages
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 27 May 2020to 7 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Oscar Lambret
Lille, Hauts-de-France, 59020
Centre Hospitalier Universitaire de Lille
Lille, 59037
About this study
Official title: 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.
Read the 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
- Conditions
- Breast Cancer
- Being tested
- Mechanical Stimulation, Massages
- Keywords
- Breast Cancer, Mechanical Stimulation, Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical StimulationProcedure or surgery
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.
MassagesProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Mechanical Stimulation | Experimental | Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, mechanical stimulation Receives: Procedure: Mechanical Stimulation |
| Arm B - Massages | Sham comparator | Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, massages. Receives: Procedure: Massages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level by a numerical scale
Pain level will be evaluated using a numerical scale of pain
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after randomization
Secondary outcomes (7)
Pain level by a numerical scale
Pain level will be evaluated using a numerical scale of pain
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: at the baseline and 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start27 May 2020
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia REGIS, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202640
- Sponsor's protocol ID
- PRESSODOU-1809
- Other IDs
- 2019-A02377-50
- Acronym
- PRESSODOU
- Status last verified
- Mar 2026
- First submitted
- 5 Jun 2019
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mechanical Stimulation on Pain Level and Functional Discomfort Following a Total Mastectomy and Exploratory Axillary Surgery
- ClinicalTrials.gov ID
- NCT04202640
- Acronym / sponsor ID
- PRESSODOU / PRESSODOU-1809
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Mechanical Stimulation, Mastectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Mechanical Stimulation | Experimental | Procedure: Mechanical StimulationPatients in this arm will receive, in addition to standard rehabilitation physiotherapy, mechanical stimulation |
| Arm B - Massages | Sham comparator | Procedure: MassagesPatients in this arm will receive, in addition to standard rehabilitation physiotherapy, massages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical StimulationThe technique of mechanical stimulation alternates between compression and decompression of the treated area. It aims to reestablish a good blood circulation and lymphatic drainage. | Procedure or surgery | Arm A - Mechanical Stimulation |
| MassagesMassages 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) | Procedure or surgery | Arm B - Massages |
Primary outcome
Pain level by a numerical scale
Time frame: 6 months after randomization
Pain level will be evaluated using a numerical scale of pain
Pain level by using Brief Pain Inventory
Time frame: 6 months after randomization
Pain level will be evaluated using Brief Pain Inventory (BPI), there is no global score for this questionnaire, each item must be considered separately.
Pain level by using QDN4 questionnaire
Time frame: 6 months after randomization
Pain level will be evaluated using QDN4 questionnaire, which is a pain scale from 0 to 10.
Mobility of the shoulders
Time frame: 6 months after randomization
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.
7 secondary outcomes
Pain level by a numerical scale
Time frame: 15 days after the end of physiotherapy
Pain level by using Brief Pain Inventory
Time frame: 15 days after the end of physiotherapy
Pain level by using QDN4 questionnaire
Time frame: 15 days after the end of physiotherapy
Mobility of the shoulders
Time frame: 15 days after the end of physiotherapy
Anxiety
Time frame: at the baseline and 6 months after
Quality of Life (QoL) with EORTC-QLQ-C30
Time frame: at the baseline and 6 months after
Quality of Life (QoL) with EORTC-QLQ-BR23
Time frame: at the baseline and 6 months after
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia REGIS, MD principal investigator
Centre Oscar Lambret
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Stimulation and Massages in people with Breast Cancer, run by Centre Oscar Lambret at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level by a numerical scale (time frame: 6 months after randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.