Clinical trial · Interventional
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
NCT04202640CI-TRIAL-00105799PRESSODOUterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient recruitment
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Massages | Procedure | — | UNRESOLVED |
| Mechanical Stimulation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A - Mechanical Stimulation
- description
- Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, mechanical stimulation
- interventionNames
- Procedure: Mechanical Stimulation
- type
- SHAM_COMPARATOR
- label
- Arm B - Massages
- description
- Patients in this arm will receive, in addition to standard rehabilitation physiotherapy, massages.
- interventionNames
- Procedure: Massages
Primary outcomes (4)
- measure
- Pain level by a numerical scale
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.