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…
ID
Bron
Verkorte titel
Aandoening
Patients treated for breast cancer and chronic pain (> 3 months) at the breast region
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is the evolution of pain at the breast region.
Doel van het onderzoek
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.
Onderzoeksopzet
- 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)
Onderzoeksproduct en/of interventie
- 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
Publiek
An De Groef
Herestraat 49
Leuven 3000
The Netherlands
+32 16 34 21 71
an.degroef@kuleuven.be
Wetenschappelijk
An De Groef
Herestraat 49
Leuven 3000
The Netherlands
+32 16 34 21 71
an.degroef@kuleuven.be
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4804 |
| NTR-old | NTR4944 |
| Ander register | EC UZ Leuven : s57283 |