Efficacy and central mechanism of acupuncture treatment in patients with neck pain: study protocol for a randomized controlled trial

Table 1 Study schedule for data collection

Period	Baseline		Treatment						Follow-up
Assessment		1						2	3	4
Time (week)	0	2	3			4			8	16
Pick-up information
Inclusion/exclusion criteria	√
Informed consent	√
Vital signs	√
Medical history	√
Physical examination	√							√
Acupuncture intervention
Group A (n=43)			√	√	√	√	√	√
Group B (n=43)			√	√	√	√	√	√
Clinical assessment
VAS	√	√						√	√	√
NDI		√						√	√	√
ROM	√	√						√	√	√
PPT		√						√	√	√
SF-36		√						√	√	√
MSUS		√						√
SAS and SDS		√						√	√	√
MRI (n=40)		√						√
Laboratory test		√						√
Adverse event								√

This is a randomized controlled trial of neuroimaging including a 2-week baseline period, a 2-week treatment period, and a 12-week follow-up period. At baseline, patients will be screened based on inclusion and exclusion criteria; eligible individuals will then sign informed consent and undergo a physical examination. After being randomized into 2 groups, 6 acupuncture treatments will be performed for 2 weeks. Clinical data will be evaluated at baseline, after treatment ends, and at 4 and 12 weeks after completion; MRI scans will be performed at baseline and after treatment. After the treatment, laboratory tests will be performed, including routine blood test, C-reactive protein, and erythrocyte sedimentation tests. Adverse events will be recorded in the CRF at any time during treatment. Abbreviations:MRI magnetic resonance imaging, VAS visual analogue scale, NDI neck disability index, ROM range of motion, PPT pressure pain thresholds, MSUS musculoskeletal ultrasound, SF-36 Short-Form 36-Item Health Survey, SAS Self-rating Anxiety Scale, SDS Self-rating Depression Scale, CRF case report form

ISSN: 1745-6215