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Fig. 2 | Trials

Fig. 2

From: Effect and cerebral mechanism of acupuncture treatment for functional constipation: study protocol for a randomized controlled clinical trial

Fig. 2

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) schedule of the trial. This is a multimodal neuroimaging randomized controlled trial which includes a two-week baseline period and a two-week treatment period. In the baseline period, recruited patients will be screened according to the inclusion criteria and exclusion criteria; then, eligible FC patients will give informed consent and receive a physical examination. After allocation, the patients will receive 10 sessions of acupuncture, sham acupuncture, PEG 4000, or no intervention during the treatment period. The outcome assessments, MRI, and PET-CT scans are performed at baseline and at the end of treatment/waiting. In addition, the stool diary and CCS will also be evaluated at the mid-point (at the end of the first week of treatment/waiting). Physical examination (blood routine test and blood biochemical test) will be performed at the end of treatment to evaluate risks correlated with acupuncture and PEG4000. Adverse events will be recorded in the CRFs at any time during treatment. PEG polyethylene glycol, fMRI functional magnetic resonance imaging, PET-CT positron emission tomography-computed tomography, CCS Cleveland Constipation Score, PAC-SYM Patient Assessment of Constipation Symptom, PAC-QoL Patient Assessment of Constipation Quality of Life Questionnaire, SAS Self-rating Anxiety Scale, SDS Self-rating Depression Scale, HRV heart rate variability

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