Table 1.

Outcome measures and time frames

Outcome measures		Time frames
Primary outcome measures	VAS Score	At baseline, 1 week, 1, 3, 6, 12, 18 and 24 months
Secondary outcome measures	ODI Score	At baseline, 1 week, 1, 3, 6, 12, 18 and 24 months
	JOA Scores system
	SF-36 health survey score
	The Modic changes of the IVD	At baseline, 6, 12, 24 months
	The Pfirrmann grade of the IVD
	Disc height
	Segment range of motion
	Vital signs: temperature, pulse, respiration, blood pressure	At 1 week, 1, 3, 6, 12, 18 and 24 months
	Blood routine
	Liver and kidney function
	Immunological examination
	Urinalysis
	Treatment emergent adverse event

IVD, intervertebral disc; JOA, Japanese Orthopaedic Association; ODI, Oswestry Disability Index; SF-36, the Mos 36-item short form; VAS, Visual Analogue Scale.