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Acupuncture for the Treatment of Parkinson's Disease Related Constipation

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Xi 'an No.3 Hospital
RECRUITING
Xi'an
Contact Information
Primary
Gejuan Zhang, Doctor
zhanggejuan@163.com
+8615934875839
Backup
Chengxue Du, Doctor
dcx1014@stu.xjtu.edu.cn
+8615771726803
Time Frame
Start Date: 2024-04-30
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 60
Treatments
Experimental: The 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.
Sham_comparator: The Sham 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.
Related Therapeutic Areas
Sponsors
Leads: Xi'an No.3 Hospital

This content was sourced from clinicaltrials.gov