No registrations found.
ID
Source
Brief title
Health condition
Patients treated for breast cancer and chronic pain (> 3 months) at the breast region
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the evolution of pain at the breast region.
Secondary outcome
- Pain-pressure thresholds of the pectoral muscles and shoulder girdle muscles
- Shoulder mobility
- Shoulder function
- Shoulder alignment
- Quality of life
Study objective
Breast cancer patients with chronic pain at the breast region will have a greater decrease in pain after a botulinum toxin infiltration, an individual physical therapy programme and home exercise programme than patients who reveive a saline solution infiltration, an individual physcial therapy programme and home exercise programme.
Study design
- baseline (before the botulinum toxin or placebo infiltration)
- 1 month (= short term effects of the infiltration)
- 3 months (= after physical therapy programme)
- 6 months (= after the home programme and end of the study)
Intervention
- botulinum toxine (experimental group) /saline solution infiltration (control group) at baseline
- at baseline start of 3 months of individual physical therapy programme (1x/week) (mobilisations, stretching, scar tissue massage, exercise therapy)
- after individual 3 months home programme with mobilizing and stretching exercises
An De Groef
Herestraat 49
Leuven 3000
The Netherlands
+32 16 34 21 71
an.degroef@kuleuven.be
An De Groef
Herestraat 49
Leuven 3000
The Netherlands
+32 16 34 21 71
an.degroef@kuleuven.be
Inclusion criteria
- women after breast cancer with unilateral axillary lymph node dissection or sentinel node biopsy; mastectomy (with or without autologous reconstruction) or wide excision of the tumour
- adjuvant chemotherapy and/or radiotherapy finished for at least 3 months
- Pain at the breast region for at least 3 months
Exclusion criteria
- Patients with metastasis and patients who cannot participate during the entire study or patients who are mentally or physically not able to participate in the study are excluded
- Cases were no injection is possible in the pectoral muscle (e.g. reconstruction with a tissue expander) are excluded as well.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4804 |
| NTR-old | NTR4944 |
| Other | EC UZ Leuven : s57283 |