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Table 1 Presents all outcome variables, data collection instruments, measures, time points and statistical analysis

From: Effectiveness of an expert assessment and individualised treatment compared with a minimal home-based exercise program in women with late-term shoulder impairments after primary breast cancer surgery: study protocol for a randomised controlled trial

Outcome variables

Data collection instrument

Measures

Time points of outcome assessment

Statistical analysis

Primary outcome

 1. Change in shoulder pain and function

SPADI (questionnaire)

Score 0–100 (continuous)

0, 4, 8 and 12 weeks

Repeated-Measures, Mixed Effects Model

Key secondary outcomes

 1. Change in shoulder pain

SPADI (questionnaire)

Score 0–10 (continuous)

0, 4, 8 and 12 weeks

Repeated-Measures, Mixed Effects Model

 2. Change in shoulder function

SPADI (questionnaire)

Score 0–10 (continuous)

0, 4, 8 and 12 weeks

Repeated-Measures, Mixed Effects Model

 3. Clinical response

SPADI minimal important change criteriaa—no. (%)

SPADI change score (dichotomous)

12 weeks (follow-up)

Logistic regression after 12 weeks

 4. Impression of the treatment´s success

GPE (questionnaire)

Score 0–7 (continuous)

4, 8 and 12 weeks

Repeated-Measures, Mixed Effects Model

 5. and 6. Change in A- and P-ROM in the affected shoulder

Smartphone Inclinometer test protocol

Degree (continuous)

0 and 12 weeks

ANCOVA

 7. Number of treatments received due to shoulder symptomsb

Questionnaire

Mean number of received treatments (continuous)

12 weeks (follow-up)

ANCOVA

 8. Change in maximum shoulder pain intensity within the previous 24 h in the affected shoulder

NRS in questionnaire

Score 0–10 (continuous)

0, 4, 8 and 12 weeks

Repeated-Measures, Mixed Effects Model

 9. Change in shoulder pain during general activities within the previous 24 h in the affected shoulder

NRS in questionnaire

Score 0–10 (continuous)

0, 4, 8 and 12 weeks

Repeated-Measures, Mixed Effects Model

 10. Change in shoulder pain at rest within the previous 24 h in the affected shoulder

NRS in questionnaire

Score 0–10 (continuous)

0, 4, 8 and 12 weeks

Repeated-Measures, Mixed Effects Model

 11. Change in shoulder pain during sleep within the previous 24 h in the affected shoulder

NRS in questionnaire

Score 0–10 (continuous)

0, 4, 8 and 12 weeks

Repeated-Measures, Mixed Effects Model

 12. Change in shoulder pain during flexion/rotation/abduction in the affected shoulder

NRS / test protocol

Score 0–10 (continuous)

0 and 12 weeks

ANCOVA

Other exploratory outcomes

 1. Pain medication consumption

Questionnaire

Type (categorical)

0, 4, 8 and 12 weeks

Logistic regression

 2. Depression score

PHQ-9 (questionnaire)

Score 0–27 (continuous)

0, 4, 8 and 12 weeks

ANCOVA

 3. Anxiety score

GAD-7 (questionnaire)

Score 0–21(continuous)

0, 4, 8 and 12 weeks

ANCOVA

Sensitivity analyses

 Per-protocol analysisc

   

ANCOVA

 As-treated analysisc

   

ANCOVA

  1. aPatients will be classified as having a clinically relevant change if the SPADI score improves by 8 points or more [51, 52]
  2. bNumber of visits to healthcare professionals (e.g. physician, chiropractor or physiotherapist) at hospital, municipality rehabilitation or private practice due to the shoulder symptoms during the intervention period
  3. cPrimary outcome. SPADI Shoulder Pain and Disability Index, GPE global perceived effect, NRS Numeric Pain Intensity Rating Scale, PHQ-9 Patient Health Questionnaire—9, GAD-7 General Anxiety Disorder – 7