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

Abstract

Background Acupuncture is effective in functional constipation (FC) treatment, but the central mechanism has not been well investigated. This trial will combine functional magnetic resonance imaging (fMRI) and positron emission tomography-computed tomography (PET-CT) to investigate the potential central mechanism of acupuncture treatment for FC. Methods This is a multimodal neuroimaging randomized controlled trial. In total, 140 FC patients will be randomly allocated into four groups: the verum acupuncture group; the sham acupuncture group; the PEG 4000 group; and the waiting-list group. This trial will include a two-week baseline period and a two-week treatment period. Patients will receive 10 sessions of acupuncture, sham acupuncture, PEG 4000, or no intervention during the treatment period. The stool diary, Cleveland Constipation Score (CCS), Patient Assessment of Constipation Symptom (PAC-SYM), and Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL) will be used to assess the clinical efficacy of different interventions. The MRI and PET-CT scans will be performed to detect cerebral functional changes in 15 patients in each group at baseline and at the end of treatment/waiting. Multimodal imaging data will be associated with clinical data to investigate possible correlation between brain activity changes elicited by different interventions and symptoms improvement. Discussion We hypothesize that acupuncture can treat FC through normalizing the pathological alteration of the cerebral activity. The results of this trial will allow us to re-testify the therapeutic effects of acupuncture treating for FC and to investigate the potential central mechanism of acupuncture treatment for FC from direct (cerebral glucose metabolism) and indirect (contrast of oxyhemoglobin and deoxyhemoglobin) approaches. Trial registration Chinese Clinical Trial Registry, ChiCTR1800016658 . Registered on 14 June 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3410-8) contains supplementary material, which is available to authorized users.

Pediatric Tuina For Functional Constipation In Children: Study Protocol For A Randomized Controlled Trail

“…Therefore, glycerine enema rate can indicate whether di cult defecation and whether child can complete defecate on his own. Other evaluation indicators such as Cleveland Constipation Score (CCS), Patient Assessment of Constipation Symptom (PAC-SYM), Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL) are not suitable for children with FC, because children (especially toddler) could not express their feelings directly and accurately [39][40][41][42].…”

Immediate acupuncture with GB34 for biliary colic: protocol for a randomised controlled neuroimaging trial

“…During each needle twirl, the needle will be bidirectionally twisted within 90° to 180°, lifted, and thrust at an even amplitude between 3 and 5 mm for 1 to 1.5 Hz (60–90 times/min) to induce and maintain the deqi sensation (including soreness, numbness, distention, and heaviness). 46 47 …”

“…For acupuncture manipulation, disposable sterile filiform needles (0.25×40 mm; Huatuo, Suzhou, China) with a Park device will be used in the acupuncture group to be perpendicularly inserted into the point at a depth of 21–26 mm after skin disinfection using alcohol (figure 5). During each needle twirl, the needle will be bidirectionally twisted within 90° to 180°, lifted, and thrust at an even amplitude between 3 and 5 mm for 1 to 1.5 Hz (60–90 times/min) to induce and maintain the deqi sensation (including soreness, numbness, distention, and heaviness) 46 47…”

Aberrant functional brain network dynamics in patients with functional constipation

“…Patients were recruited from the Hospital of Chengdu University of Traditional Chinese Medicine and the campus of Chengdu University of Traditional Chinese Medicine from September 2018 to January 2020. After being diagnosed by two gastroenterologists according to the Rome IV Diagnostic Criteria for FCon (Lacy et al, 2016 ) and undergoing physical and laboratory examinations (Yin et al, 2019 ), the potential patients who met the following inclusion criteria were included: (a) were right‐handed and aged from 18 to 40 years, (b) did not take any gastrointestinal prokinetic agent or laxative at least 15 days before enrollment, (c) did not participate in any clinical trial in the past 3 months, and (d) signed informed consent. Patients were excluded if they (a) suffered from organic or metabolic diseases; (b) had organic changes in the rectum (such as lumps or rectal stenosis) examined by rectal fingerprints; (c) were afflicted with acute or chronic pain disorders, or severe depression, or anxiety; (d) had a history of head trauma, gastrointestinal surgery, or psychiatric or neurological disorders, (e) were pregnant or lactating, or intended to pregnant in the 6 months, and (f) had any contraindication of MRI scans such as implanted ferromagnetic metal or claustrophobia.…”

“…Patients were recruited from the Hospital of Chengdu University of Traditional Chinese Medicine and the campus of Chengdu University of Traditional Chinese Medicine from September 2018 to January 2020. After being diagnosed by two gastroenterologists according to the Rome IV Diagnostic Criteria for FCon (Lacy et al, 2016) and undergoing physical and laboratory examinations (Yin et al, 2019), the potential patients who met the following inclusion criteria were included: (a) were right-…”