Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial

Table 1 Summary of primary, secondary, and exploratory outcome measures

Outcomes	Definition	Time
Outcomes	Definition	Week 6	Week 12	Week 24	Week 52
1. Primary outcome
1.1 Spinal pain score	Overall level of pain at neck, back, or hip	✓
2. Main secondary outcome
2.1 Spinal pain score	Overall level of pain at neck, back, or hip			✓
3. Other secondary outcomes
3.1 Clinical outcomes
3.1.1 Spinal pain score	Overall level of pain at neck, back, or hip		✓
3.1.2 BASDAI	Disease activity of patient	✓	✓	✓
3.1.3 BASFI	Disease-specific physical function	✓	✓	✓
3.1.4 BAS-G	Global assessment of disease	✓	✓	✓
3.1.5 HAQ	Disability	✓	✓	✓
3.2 Quality of life outcomes
3.2.1 SF-36	General QoL assessment	✓	✓	✓
3.2.2 ASQoL	Disease-specific QoL assessment	✓	✓	✓
3.3 Economic outcomes
3.3.1 Costs	Direct and indirect costs of disease	✓	✓	✓
4. Exploratory outcomes
4.1 Clinical outcomes
4.1.1 Spinal pain score	Overall level of pain at neck, back, or hip				✓
4.1.2 BASDAI	Disease activity of patient				✓
4.1.3 BASFI	Disease-specific physical function				✓
4.1.4 BAS-G	Global assessment of disease				✓
4.1.5 HAQ	Disability				✓
4.2 Quality of life outcomes
4.2.1 SF-36	General QoL assessment				✓
4.2.2 ASQoL	Disease-specific QoL assessment				✓
4.3 Economic outcomes
4.3.1 Costs	Direct and indirect costs of disease				✓

Baseline data will be collected for all outcome measures except for costs
Abbreviations: ASQoL Ankylosing Spondylitis Quality of Life, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BASFI Bath Ankylosing Spondylitis Functional Index, BAS-G Bath Ankylosing Spondylitis Global score, HAQ Health Assessment Questionnaire, SF-36 36-item Short Form Health Survey, QoL quality of life

ISSN: 1745-6215