Effect of Intradermal Thumbtack Needle for Functional Constipation: Study Protocol for a Real- World Clinical Trial

Abstract Background: Many high-quality clinical trials have proved the efficacy of acupuncture in the improving frequency of spontaneous bowel movements, stool characteristics, and et cetera of Functional Constipation (FC) [1]. However, the high requirement of time make many patients unable to attend, this clinical trial will demonstrate the efficacy of intradermal thumbtack needle in ameliorate spontaneous bowel movement of FC.Methods: This multi-center real world clinical trial is performed involving 482 FC patients. All patients are randomly allocated into 2 group, which are group A to receive intradermal thumbtack needle twice a week for 4 weeks (intervention group n=241) or group B to take oral administration of mosapride 3 times a day for 4 weeks (control group n=241). This trial includes a 4-week treatment period and a 4-week follow-up period. The primary outcome is the number of completely spontaneous defecation per week, we use Weekly CSBMs analyze the frequency of spontaneous defecation per week during treatment and follow-up period to compared with the baseline. The secondary outcomes include FC patients’ stool consistence, gastrointestinal or anorectal symptoms, quality of life, anxiety and depression levels during treatment and follow-up period and efficacy expectations. The relevant assessment tools include: Bristol tool Form Scale (BSFS), Cleveland Constipation Score (CCS), Patient Assessment of Constipation Quality of Life Questionnaire(PAC－QOL), Self-rating Anxiety Scale (SAS) , Self-rating Depression Scale (SDS) and Efficacy Expectancy Scale. At the end, the scales filled by patients and researchers will be entered by data administrator, all the outcome assessments will be performed by independent outcome assessors and will be analyzed by professional statisticians with SPSS 25.0 software.Discussion: We hypothesize that intradermal needle is better than or equal to positive drugs in the improving frequency of spontaneous bowel movements, stool characteristics，and et cetera of FC patients . The results of this trial will provide us with a clinical basis for the application of intradermal needles in the treatment of FC.Trial registration: Chinese Clinical Trial Registry, ChinCTR2100043684.Registered on 26 February 2021.