Actively Recruiting
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
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of acupuncture in treating constipation related to Parkinson's disease (PDC). This randomized controlled clinical trial divides eligible patients into two groups: one receiving acupuncture and the other receiving sham acupuncture. The study aims to observe changes in bowel movements, constipation symptoms, quality of life, and Parkinson's disease symptoms, using standardized scales and physiological tests at baseline, after treatment, and during follow-up. The acupuncture treatment involves inserting needles at specific traditional Chinese medicine points to a depth of 0.8 to 1 cm. The sham acupuncture group receives needles inserted at shallower depths of 0.2 to 0.3 cm at nonacupuncture points near the real acupoints. Both groups are monitored over a 4-week treatment period followed by an 8-week follow-up phase. This design allows comparison of the effects of real versus sham acupuncture on constipation and related Parkinson's symptoms. Participants will be asked to keep an electronic bowel diary during the study. Researchers will assess weekly complete spontaneous bowel movements (CSBMs), constipation symptoms, quality of life, and Parkinson's disease rating scores at weeks 0, 4, and 12. Colonic transit time and anorectal manometry will also be evaluated at these time points using radiopaque markers and water-perfused catheters to measure bowel function. The study's total duration includes baseline, treatment, and follow-up phases, with detailed physiological and questionnaire assessments to monitor outcomes.
CONDITIONS
Brief Title
Efficacy of Acupuncture for the Treatment of Parkinson's Disease Related Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Parkinson's disease according to the Movement Disorder Society's 2015 criteria and functional constipation per Rome IV criteria
- Age between 35 and 80 years
- Hoehn-Yahr grade of 3 or less
- No medications affecting gastrointestinal function taken within 2 weeks
- No participation in other clinical trials within 1 month
- Willingness and ability to sign informed consent and complete bowel diary and questionnaires
You will not qualify if you...
- Presence of organic digestive system lesions such as intestinal adhesions, obstructions, tumors, or malformations
- History of abdominal or anorectal surgery affecting intestinal transit, or systemic diseases like diabetes or hyperthyroidism affecting digestion
- Serious life-threatening diseases such as severe cardiovascular disease or malignant tumors
- Skin conditions unsuitable for needling or allergies preventing acupuncture device use
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants complete baseline assessments including electronic bowel diary, anorectal manometry, and colonic transit time evaluations.
1 visit (in-person)
Duration - 4 weeks
Participants receive acupuncture or sham acupuncture according to group assignment.
Weekly visits for up to 4 weeks
Duration - 8 weeks
Participants continue to complete the electronic bowel diary and undergo follow-up assessments to monitor constipation symptoms and Parkinson's disease rating.
1 visit at week 12 (in-person)
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
C
Chengxue Du, Doctor
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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