Efficacy of Acupuncture for the Treatment of Parkinson's Disease Related Constipation

NCT06390761 · tracked via the Priya Life Science China tracker

Sponsor

Xi'an No.3 Hospital

Phase

Not applicable

Started

2024-04-30

Last updated

2024-05-02

Condition(s) studied

Parkinson DiseaseConstipationNon-motor SymptomRandomized Controlled Trial

Investigational drug(s) / intervention(s)

Acupuncture

Acupuncture: All acupoints were selected based on traditional Chinese medicine theory and previous articles on PD and constipation.

Study 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

Sex

ALL

Min age

35 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. 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) ; 2. Age between 35 and 80 years; 3. Hoehn-Yahr grade ≤ 3; 4. No medications taken within 2 weeks that may affect gastrointestinal function (such as prucalopride and probiotics); 5. No anticipation in other clinical trials within 1 month; 6. 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: 1. Organic lesions of the digestive system (such as intestinal adhesions, obstructions, tumors, or malformations in the gastrointestinal tract); 2. 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); 3. Serious life-threatening diseases (such as severe cardiovascular diseases and malignant tumors); 4. Skin lesions that were inappropriate for needling, the viscose allergy that prevented acupuncture device attachment; 5. Pregnant or lactating women.

Primary outcome measure(s)

The number of weekly CSBMs — Weekly CSBMs were collected at baseline (week 0), post-treatment (week 4), and follow-up (week 12), and differences from baseline levels were compared at week 4 and week 12.
Complete spontaneous bowel movements

Trial sites (1)

Facility	City	Region	Status
Xi 'an No.3 Hospital	Xi'an	Shaanxi	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06390761 on ClinicalTrials.gov ↗ ← All trials in China