Effect of Acupuncture Therapy on Dysphagic Parkinson's Patients

NCT ID: NCT06255756

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2024-06-30

Brief Summary

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We are currently conducting a randomized controlled study in China, specifically in three hospitals' rehabilitation medicine departments, focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants.

Detailed Description

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We are currently conducting a randomized controlled study in China, specifically in three hospitals' rehabilitation medicine departments, focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants.

The study lasted 42 days (6 weeks) for each participant. Specifically, our main focus is on the study of Lianquan, Shanglianquan (depression between the hyoid bone and the lower border of the mandible), Yifeng, Fengchi, Wangu, Fengfu, Yamen, Neidaying (depression of 1 inch below the anterior margin of the mandible), Jinjin, Yuye, posterior pharyngeal wall (both sides of the uvula).

Conditions

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Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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routine treatment+swallowing rehabilitation training+acupuncture therapy

The experimental group was given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy.

Group Type EXPERIMENTAL

Routine rehabilitation training

Intervention Type BEHAVIORAL

Balance function training: Patients were instructed to achieve weight shift between the left and right sides of the balance bar in a standing position.

Walking function training: based on hip, knee, and ankle control training, patients were instructed to take steps training.

Core muscle strength training: Patients were instructed to maintain 3 minutes of training in Bridge-style movement.

Functional training of daily living: including training on dressing and undressing, independent eating, painting, and writing.

Routine rehabilitation training was performed 30-45 minutes/time, 1-2 times/day, 5-7 days/week.

Swallowing rehabilitation training

Intervention Type BEHAVIORAL

Swallowing-related organ training involves various exercises targeting the lip, mandibular muscle, cheek, tongue muscle, soft palate, as well as exercises for vocal cord closure, laryngeal lifting, and pharyngeal muscle training. These exercises are performed for 5-15 minutes each session, 1-2 times per day, and 5-7 days per week.

Sensory stimulation training is conducted using a self-made popsicle, where medical staff gently stimulate the patient's cheek, palatoquadrate, soft palate, posterior pharyngeal wall, tongue surface, and sublingual area repeatedly. Each session lasts 5-25 minutes, performed 1-3 times per day, and 3-7 days per week.

Once the patient's swallowing function improves to a certain extent, allowing for safe oral intake, direct training or oral feeding training can be gradually introduced.

Acupuncture therapy

Intervention Type PROCEDURE

The whole acupuncture therapy was performed once daily for 5 days per week, including acupuncture needle and tongue needle.

Acupuncture needle:

Main acupoints: Lianquan, Shanglianquan (depression between the hyoid bone and the lower border of the mandible), Yifeng; Auxiliary acupoints: Fengchi, Wangu, Fengfu, Yamen, Neidaying (depression of 1 inch below the anterior margin of the mandible).

Tongue needle (pricking):

Acupoints: Jinjin, Yuye, posterior pharyngeal wall (both sides of the uvula).

routine treatment+swallowing rehabilitation training

The control group was given routine treatment and swallowing rehabilitation training.

Group Type ACTIVE_COMPARATOR

Routine rehabilitation training

Intervention Type BEHAVIORAL

Balance function training: Patients were instructed to achieve weight shift between the left and right sides of the balance bar in a standing position.

Walking function training: based on hip, knee, and ankle control training, patients were instructed to take steps training.

Core muscle strength training: Patients were instructed to maintain 3 minutes of training in Bridge-style movement.

Functional training of daily living: including training on dressing and undressing, independent eating, painting, and writing.

Routine rehabilitation training was performed 30-45 minutes/time, 1-2 times/day, 5-7 days/week.

Swallowing rehabilitation training

Intervention Type BEHAVIORAL

Swallowing-related organ training involves various exercises targeting the lip, mandibular muscle, cheek, tongue muscle, soft palate, as well as exercises for vocal cord closure, laryngeal lifting, and pharyngeal muscle training. These exercises are performed for 5-15 minutes each session, 1-2 times per day, and 5-7 days per week.

Sensory stimulation training is conducted using a self-made popsicle, where medical staff gently stimulate the patient's cheek, palatoquadrate, soft palate, posterior pharyngeal wall, tongue surface, and sublingual area repeatedly. Each session lasts 5-25 minutes, performed 1-3 times per day, and 3-7 days per week.

Once the patient's swallowing function improves to a certain extent, allowing for safe oral intake, direct training or oral feeding training can be gradually introduced.

Interventions

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Routine rehabilitation training

Balance function training: Patients were instructed to achieve weight shift between the left and right sides of the balance bar in a standing position.

Walking function training: based on hip, knee, and ankle control training, patients were instructed to take steps training.

Core muscle strength training: Patients were instructed to maintain 3 minutes of training in Bridge-style movement.

Functional training of daily living: including training on dressing and undressing, independent eating, painting, and writing.

Routine rehabilitation training was performed 30-45 minutes/time, 1-2 times/day, 5-7 days/week.

Intervention Type BEHAVIORAL

Swallowing rehabilitation training

Swallowing-related organ training involves various exercises targeting the lip, mandibular muscle, cheek, tongue muscle, soft palate, as well as exercises for vocal cord closure, laryngeal lifting, and pharyngeal muscle training. These exercises are performed for 5-15 minutes each session, 1-2 times per day, and 5-7 days per week.

Sensory stimulation training is conducted using a self-made popsicle, where medical staff gently stimulate the patient's cheek, palatoquadrate, soft palate, posterior pharyngeal wall, tongue surface, and sublingual area repeatedly. Each session lasts 5-25 minutes, performed 1-3 times per day, and 3-7 days per week.

Once the patient's swallowing function improves to a certain extent, allowing for safe oral intake, direct training or oral feeding training can be gradually introduced.

Intervention Type BEHAVIORAL

Acupuncture therapy

The whole acupuncture therapy was performed once daily for 5 days per week, including acupuncture needle and tongue needle.

Acupuncture needle:

Main acupoints: Lianquan, Shanglianquan (depression between the hyoid bone and the lower border of the mandible), Yifeng; Auxiliary acupoints: Fengchi, Wangu, Fengfu, Yamen, Neidaying (depression of 1 inch below the anterior margin of the mandible).

Tongue needle (pricking):

Acupoints: Jinjin, Yuye, posterior pharyngeal wall (both sides of the uvula).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years.
* Meeting the diagnostic criteria for Parkinson's disease.
* Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
* Water swallow test\> Level 3.
* Stable vital signs, conscious, able to cooperate with assessment and treatment.

Exclusion Criteria

* Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
* History of mental diseases or use of antipsychotics.
* Complicated with cognitive impairment or consciousness dysfunction.
* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zeng Changhao

OTHER

Sponsor Role lead

Responsible Party

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Zeng Changhao

Research Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nieto Luis, Master

Role: STUDY_DIRECTOR

Site Coordinator of United Medical Group

Locations

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Zheng Da yi Yuan Hospital

Zhenzhou, Henan, China

Site Status

Countries

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China

Other Identifiers

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Zhenjiu-Parkinson

Identifier Type: -

Identifier Source: org_study_id

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