Efficacy of Acupuncture for the Treatment of Parkinson's Disease Related Constipation
Recruiting · NCT06390761 · Interventional (participants receive a specific treatment) · Lead sponsor: Xi'an No.3 Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of the study is to evaluate the efficacy of acupuncture in treating Parkinson's disease related constipation (PDC). In the randomized controlled clinical trial study, patients meeting the criteria for inclusion will be randomly enrolled and divided into two groups in a 1:1 ratio: the acupuncture group and the sham acupuncture group. The intervention is going to be executed using the acupoints EX-HN1（Sishencong),LI4 (Hegu),ST25 (Tianshu),ST37(Shangjuxu),ST36(Zusanli),ST44 (Neiting), ST44 (Taichong), SP6 (Sanyinjiao) and CV4 (Shuangyuan).The acupuncture needles will be inserted to a depth of 0.8 to 1 cm in the acupuncture group. The sham acupuncture group's needles will be inserted to a depth of 0.2 to 0.3 cm with nonacupuncture points located 0.5 cm in lateral to the real acupoint or to the right for midline points. During the study, researchers will observe changes in complete spontaneous bowel movements (CSBMs), Constipation Symptom and Efficacy Assessment Scale (CSEAS) (including the six dimensions of difficulty, Bristol, time, incompleteness, frequency,and bloating), the Patient-Assessment of Constipation Quality of Life questionnaire (PAC-QOL), and the Unified Parkinson's Disease Rating Scale (UPDRS) at baseline (week 0), post-treatment (week 4), and follow-up (week 12).Colonic transit time measurement and conventional anorectal manometry were evaluated at the above time points.
Who can take part
Inclusion criteria
- A diagnosis of PD (according to the Movement Disorder Society's revised clinical diagnostic criteria for Parkinson's disease in 2015) and functional constipation (according to the Rome IV diagnostic criteria) ;
- Age between 35 and 80 years;
- Hoehn-Yahr grade ≤ 3;
- No medications taken within 2 weeks that may affect gastrointestinal function (such as prucalopride and probiotics);
- No anticipation in other clinical trials within 1 month;
- Voluntary engagement in this study, ability to sign the informed consent, and cooperation in the completion of the bowel diary and scale filling.
Exclusion criteria
- Organic lesions of the digestive system (such as intestinal adhesions, obstructions, tumors, or malformations in the gastrointestinal tract);
- A history of abdominal or anorectal surgery that may affect intestinal transit, systemic diseases that may affect the dynamics of the digestive tract (such as diabetes and hyperthyroidism);
- Serious life-threatening diseases (such as severe cardiovascular diseases and malignant tumors);
- Skin lesions that were inappropriate for needling, the viscose allergy that prevented acupuncture device attachment;
- Pregnant or lactating women.
Where it is running
1 location listed.
- Xi 'an No.3 Hospital - Xi'an, Shaanxi, China