Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study)

Table 1 Time points of each assessment index

	Study period
Time point	Enrollment	Allocation	Active treatment post allocation						Follow-up
Time point	Week −1	Week 0 (Baseline)	Week 1	Week 2	Week 3	Week 4	Week 5	Week 6	Week 7	Week 10	Week 14
Enrollment
Eligibility screening	○
Written informed consent	○
Vital signs	○								○	○	○
Sociodemographic characteristics, medical history (e.g., LBP, medication history)	○
Physical examination	○
Randomized allocation		○
Interventions
Treatment in CMT group			←2–3 times/week →				←1–3 times/week →
Treatment in UC^a group (times/week)			←2–3 times/week →				←1–3 times/week →
Treatment in CMT + UC^a group (times/week)			←2–3 times/week →				←1–3 times/week →
Assessments
Symptoms and change in medicine		○		○	○	○	○	○	○	○
NRS of LBP and leg pain	○	○		○	○	○	○	○	○	○	○
ODI		○					○		○	○
PGIC							○		○	○
ROM		○					○		○	○
EQ-5D		○					○		○	○	○
HUI-III		○					○		○	○	○
Economic evaluation		○					○		○	○	○
Adverse events		○	← every visit →						○	○	○

CMT Chuna manual therapy, UC usual care, NRS Numeric Rating Scale, LBP low back pain, ODI Oswestry Disability Index, PGIC Patient Global Impression of Change, ROM range of movement, EQ-5D EuroQol-5 dimensions, HUI-III Health Utility Index III
^aUC: medication will be administered daily and physical therapy will be applied 2–3 times/week

ISSN: 1745-6215