Clinical trial · Interventional
Effect of Mechanical Stimulation on Mastectomy Scars
A Prospective Randomized Clinical Trial to Investigate the Effect of Mechanical Stimulation on Mastectomy Scars
NCT02702050CI-TRIAL-00032377completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate the efficacy of mechanical stimulation on mastectomy scars in: (i) alleviating scar appearance - pigmentation, vascularity, pliability and thickness, (ii) reducing shoulder morbidities, (iii) improving arm functions, and (iv) enhancing quality of life, in women with breast cancer after mastectomy.
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 |
|---|---|---|---|
| Conventional treatment | Other | — | UNRESOLVED |
| Mechanical stimulation (LPG system; Cellu M6 Integral I) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional treatment group
- description
- Conventional treatment group will receive an educational session before commencement of the program. Twelve sessions of 40-minute remedial exercises, 5-minute warm up and 5-minute cool down exercises will be provided within a 6-week period (i.e., two sessions per week) to all subjects. No mechanical stimulation will be given.
- interventionNames
- Other: Conventional treatment
- type
- EXPERIMENTAL
- label
- Mechanical stimulation group
- description
- A 10 minute mechanical stimulation program - 'Mechanical stimulation (LPG system; Cellu M6 Integral I), will be provided after each of the twelve sessions of conventional treatment.
- interventionNames
- Other: Mechanical stimulation (LPG system; Cellu M6 Integral I)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18 years old or above with mastectomy performed in recent 6 weeks; * Able to attend physiotherapy treatment and follow-ups during the study period. Exclusion Criteria: * Altered mental state for cooperation and informed consent; * Signs and symptoms of mastectomy scar infections or inflammations; * Unhealed mastectomy wounds; * History of lymphoedema; * Diagnosed bilateral breast cancers; * Unstable medical or cardiovascular conditions; * Pre-existing arm impairments/dysfunctions that will affect testing or exercising the affected arm; * Receiving radiotherapy during the study period; * Known sensitivity to mechanical stimulation; * Skin cancer on the treatment area; * Unclear cut margins of the cancer; * Known metastasis to other areas; * HIV positive.
References
Publications (0)
Data not yet available
No reference posted for this study.