How Acupuncture Therapy Improves Dysphagia in Parkinson's Patients

NCT06303895 | Not Yet Recruiting

• 1 other identifier: Acu-PKS-new
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is 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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (2)

• Penetration-Aspiration Scale-liquid

  The Penetration-Aspiration Scale (PAS) was conducted under video fluoroscopic swallowing study. PAS is a standardized tool used to assess the safety of swallowing. The scale was developed to evaluate the entry of material into the airway (penetration) and the subsequent passage of material below the vocal folds (aspiration) during swallowing. The PAS scale ranges from 1 to 8, with each level representing different degrees of penetration or aspiration

  Day 1 and Day 42

• Penetration-Aspiration Scale-paste

  The Penetration-Aspiration Scale (PAS) was conducted under video fluoroscopic swallowing study. PAS is a standardized tool used to assess the safety of swallowing. The scale was developed to evaluate the entry of material into the airway (penetration) and the subsequent passage of material below the vocal folds (aspiration) during swallowing. The PAS scale ranges from 1 to 8, with each level representing different degrees of penetration or aspiration.

  Day 1 and Day 42

Secondary Outcomes (6)

• Swallowing time

  Day 1 and Day 42

• body mass index

  Day 1 and Day 42

• Serum Albumin

  Day 1 and Day 42

• Prealbumin

  Day 1 and Day 42

• Hemoglobin

  Day 1 and Day 42

Study Arms (2)

routine treatment+swallowing rehabilitation training+acupuncture therapy

EXPERIMENTAL

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

Behavioral: Routine rehabilitation training; Behavioral: Swallowing rehabilitation training; Procedure: Acupuncture therapy

routine treatment+swallowing rehabilitation training

ACTIVE COMPARATOR

The control was given routine treatment and swallowing rehabilitation training

Behavioral: Routine rehabilitation training; Behavioral: Swallowing rehabilitation training

Interventions

Routine rehabilitation training 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.

routine treatment+swallowing rehabilitation training; routine treatment+swallowing rehabilitation training+acupuncture therapy

Swallowing rehabilitation training 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, 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.

routine treatment+swallowing rehabilitation training; routine treatment+swallowing rehabilitation training+acupuncture therapy

Acupuncture therapy 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+acupuncture therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muhammad: lead

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group

  STUDY DIRECTOR

Central Study Contacts

Lavie Ce, Master

CONTACT

15333828388; zenghongjixx@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share