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

NCT06390761 | Recruiting

• 2 other identifiers: AFPDC2020qn06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Constipation; Non-motor Symptom; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• The number of weekly CSBMs

  Complete spontaneous bowel movements

  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.

Secondary Outcomes (5)

• Constipation Symptom and Efficacy Assessment Scale (CSEAS)

  CSEAS 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.

• Patient-Assessment of Constipation Quality of Life questionnaire (PAC-QOL)

  PAC-QOL 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.

• The Unified Parkinson's Disease Rating Scale (UPDRS)

  These were assessed 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.

• TT

  TT was assessed 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.

• AM

  AM was assessed 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.

Study Arms (2)

The Acupuncture Group

EXPERIMENTAL

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.

Procedure: Acupuncture

The Sham Acupuncture Group

SHAM COMPARATOR

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.

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

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

The Acupuncture Group; The Sham Acupuncture Group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xi'an No.3 Hospital: lead

Study Sites (1)

Xi 'an No.3 Hospital

Xi'an, Shaanxi, 710018, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Constipation

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Gejuan Zhang, Doctor

  The dean

  STUDY DIRECTOR

Central Study Contacts

Gejuan Zhang, Doctor

CONTACT

+8615934875839; zhanggejuan@163.com

Chengxue Du, Doctor

CONTACT

+8615771726803; dcx1014@stu.xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 30, 2024
• Study Start: April 30, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)