Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial

Table 1 Trial process

	Baseline	Treatment			Follow-up
Time	−1w	0w	2w	4w	8w
Assessment		1st	2nd	3rd	4th
Patients
Medical history	√
Physical examination	√	√	√	√
Laboratory examination	√			√
Sign informed consent		√
Randomization		√
Intervention and control
HCI group	16 sessions of acupuncture
LOI group	16 sessions of acupuncture
MC group	5 mg mosapride citrate tablet, three times a day
Outcomes
Number of defecating events per week		√	√	√	√
Shape and properties of stool		√	√	√	√
Intensity of defecating difficulty		√	√	√	√
PAC-QOL		√	√	√	√
SF-36		√		√
SAS		√	√	√
SDS		√	√	√
The time of the first spontaneous defecation
Safety assessment
Safety of electro-acupuncture		√	√	√
Adverse event		√	√	√
Trial evaluation
Patient’s compliance				√
Rates of dropouts and withdrawals				√

HCI high current intensity; LCI low current intensity; PAC-QOL Patient Assessment of Constipation Quality of Life; SF-36 MOS item Short Form health survey; SAS Self-Rating Anxiety Scale; SDS Self-rating Depression Scale.

ISSN: 1745-6215