Effectiveness of an individualised treatment plan compared with a standard exercise programme in women with late-term shoulder impairments after primary breast cancer treatment: a randomised controlled trial.

Background and purpose: Research focuses on lymphedema, yet up to 50% face chronic shoulder issues 6 years post-treatment, while rehabilitation for this group is unclear. This trial aimed to assess the clinical effects of a shoulder expert assessment followed by an individualised treatment plan (Intervention Group; IG) compared with standardised exercises delivered as a pamphlet (Control comparator Group; CG), on changes in Shoulder Pain and Disability Index (SPADI) from baseline to week 12.

Material and methods: This 12-week, assessor-blinded, parallel-group randomised controlled trial included women with late-term shoulder impairments 3-7 years post-breast cancer. Participants were randomized (1:1 allocation) and stratified by surgery and radiotherapy. Outcomes were assessed at baseline, 4, 8, and 12 weeks. Primary endpoint was SPADI overall score change at 12 weeks, analysed using a mixed model. The trial was designed to detect a between-group difference of 8 points on SPADI overall score after 12 weeks. Secondary outcomes were SPADI pain/function, global perceived effect, changes in shoulder pain numeric rating scale, active and passive shoulder range of motion.

Results: After 12-weeks, no between-group difference in SPADI was found between IG and CG (-10.5 and -14.4, respectively), corresponding to a difference of -3.9 points (95% CI -11.9 to 4.1; P = 0.34).

Interpretation: The effects on shoulder pain and disability symptoms of a shoulder expert assessment followed by an individualised treatment plan was not superior to standardised exercises delivered as a pamphlet in women with late-term shoulder impairments 3-7 years post-breast cancer.

Trial registration: ClinicalTrials.gov (NCT05277909).