Actively Recruiting
Efficacy of Acupuncture for the Treatment of Parkinson's Disease Related Constipation
Led by Xi'an No.3 Hospital · Updated on 2024-05-02
60
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Efficacy of Acupuncture for the Treatment of Parkinson's Disease Related Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Parkinson's disease according to the 2015 Movement Disorder Society criteria and functional constipation by Rome IV criteria
- Age between 35 and 80 years
- Hoehn-Yahr stage 3 or lower
- No medications affecting gastrointestinal function taken within 2 weeks
- No participation in other clinical trials within the past month
- Willing and able to provide informed consent and complete bowel diaries and questionnaires
You will not qualify if you...
- Presence of organic digestive system lesions (e.g., intestinal adhesions, obstructions, tumors, malformations)
- History of abdominal or anorectal surgery affecting intestinal transit or systemic diseases impacting digestive tract function (e.g., diabetes, hyperthyroidism)
- Serious life-threatening conditions such as severe cardiovascular disease or cancer
- Skin conditions unsuitable for acupuncture or allergies preventing device use
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xi 'an No.3 Hospital
Xi'an, Shaanxi, China, 710018
Actively Recruiting
Research Team
G
Gejuan Zhang, Doctor
CONTACT
C
Chengxue Du, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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