Abstract
Abstract
Background
In breast cancer patients, late-term upper limb sequelae, such as shoulder pain and impaired shoulder function, remain common after primary breast cancer surgery. The aim of this trial is to evaluate whether an expert assessment of shoulder impairments, followed by an individualised treatment plan, is superior to a minimal physiotherapeutic rehabilitation program in reducing shoulder symptoms, among women with late-term shoulder impairments after primary breast cancer.
Methods/design
The study is designed as a stratified, parallel-group, assessor-blinded, randomised, controlled trial conducted in Denmark; 130 participants with late-term shoulder impairments 3–7 years after primary surgery for breast cancer will be recruited. Participants will be randomised (allocation 1:1) to either an expert assessment of shoulder impairments followed by an individualised treatment plan or to follow a minimal physiotherapeutic rehabilitation program delivered in a pamphlet. The primary outcome will be a change in shoulder pain and function from baseline to 12 weeks after initiating the treatment, as measured by the patient-reported outcome Shoulder Pain and Disability Index (SPADI) questionnaire.
Discussion
There has been an insufficient focus in research and clinical practice on late-term shoulder impairment in women following surgery for breast cancer. This trial will focus on interventions towards late-term shoulder impairments and is expected to provide evidence-based knowledge to physiotherapists and women about the management of shoulder pain and impaired shoulder function.
Trial registration
ClinicalTrials.gov NCT05277909. Registered on 11 March 2022.
Funder
Region of Southern Denmark
The Danish Physiotherapists Research fund
Hospital Lillebaelt
Fru Astrid Thaysens Legat for Lægevidenskabelig Grundforskning
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference84 articles.
1. World Cancer Research Fund International. Breast Cancer Statistics. 2022 [cited 08 Aug 2022]. Available from: http://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/breast-cancer-statistics
2. Danske Multidisciplinære Cancer Grupper (DMCG). Kirurgisk behandling af brystkræft – version 2.1. 2022 [cited 08 Aug 2022]. Available from: https://www.dmcg.dk/Kliniske-retningslinjer/kliniske-retningslinjer-opdelt-paa-dmcg/brystcancer/kirurgisk-behandling-af-brystkraft/
3. Nielsen HM, Friis RB, Linnet S, Offersen BV. Loco-regional morbidity after breast conservation and axillary lymph node dissection for early breast cancer with or without regional nodes radiotherapy, perspectives in modern breast cancer treatment: the Skagen Trial 1 is active. Acta Oncol. 2017;56(5):713–8.
4. World Cancer Research Fund International. Cancer Survival Statistics. 2020 [cited 08 Aug 2022]. Available from: https://www.wcrf.org/cancer-trends/cancer-survival-statistics/
5. Kræftens Bekæmpelse. Statistik om brystkræft. 2022 [cited 08 Aug 2022]. Available from: https://www.cancer.dk/brystkraeft-mammacancer/statistik-brystkraeft/