Acupuncture Therapy on Dysphagia in Parkinson's Disease

NCT06199323 | Completed DMC

• 1 other identifier: 2019-KS-HNSR008
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

From June 2019 to May 2021, we conducted a randomized controlled study, including dysphagic patients with Parkinson's diseases who were admitted to the department of rehabilitation medicine in 3 hospitals in China. The participants were divided randomly into the experimental group and the control group, with 56 in each one. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy.

Conditions

Parkinson Disease

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. In this assessment, we used 60% barium sulfate suspension A higher level of PAS indicated a severer dysphagia.

  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. In this assessment, we used 180% barium sulfate suspension A higher level of PAS indicated a severer dysphagia.

  day 1 and day 42

Secondary Outcomes (13)

• Swallowing time-The oral transit time-liquid

  day 1 and day 42

• Swallowing time-The oral transit time-paste

  day 1 and day 42

• Swallowing time-swallowing reaction time-liquid

  day 1 and day 42

• Swallowing time-pharyngeal transit time -liquid

  day 1 and day 42

• Swallowing time-laryngeal closure duration-liquid

  day 1 and day 42

Study Arms (2)

routine treatment+swallowing rehabilitation training+acupuncture therapy

EXPERIMENTAL

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

Behavioral: Routine rehabilitation training; Behavioral: Swallowing rehabilitation training

Interventions

Routine rehabilitation training BEHAVIORAL

1. Balance function training: Patients were instructed to achieve weight shift between the left and right sides of the balance bar in a standing position. 2. Walking function training: based on hip, knee, and ankle control training, patients were instructed to take steps training. 3. Core muscle strength training: Patients were instructed to maintain 3 minutes of training in Bridge-style movement. 4. 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

1. Swallowing-related organ training: including movement training of lip, mandibular muscle, cheek, tongue muscle, soft palate, as well as exercises of vocal cord closure, laryngeal lifting and pharyngeal muscle training. 5-15 minutes/time, 1-2 times/day, 5-7 days/week. 2. Sensory stimulation training: With the self-made popsicle, medical staff slowly and gently stimulated the patient's cheek, palatoquadrate, soft palate, posterior pharyngeal wall, tongue surface and sublingual area repeatedly. 5-25 minutes/time, 1-3 times/day, 3-7 days/week. 3. Direct training: When the patient's swallowing function improves to a certain extent of which the safety of oral intake can be basically ensured, oral feeding training (direct training) can be attempted gradually. 4. Mendelsohn maneuver: During the Mendelsohn maneuver, the patient consciously prolonged the duration of the muscle contraction in the throat during swallowing.15-30 minutes/time, once per day, 5 days/week.

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 developed by the Neurology Branch of the Chinese Medical Association in 2006.
• 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

• Zeng Changhao: lead

Study Sites (1)

Quanmi Hos.

Pingdong, Taiwan

Location

Related Publications (1)

• Zeng HJ, Zhao WJ, Luo PC, Zhang XY, Luo SY, Li Y, Li HP, Wang LG, Zeng X. Acupuncture Therapy on Dysphagia in Patients with Parkinson's Disease: A Randomized Controlled Study. Chin J Integr Med. 2025 Mar;31(3):261-269. doi: 10.1007/s11655-024-3668-x. Epub 2024 Sep 21.

  PMID: 39305459 DERIVED

MeSH Terms

Conditions

Parkinson Disease

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group located in Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All researchers were required to maintain isolation from participants beyond necessary contact and strictly keep confidentiality of research content. We used blind labels to identify participants' intervention or treatment allocation. These labels remained confidential during the research process and were accessible only to researchers and specific staff. In addition, all data collection and assessment were conducted by professionals who were not involved in the intervention and were not aware of the study design to ensure objectivity and independence. All medical staff responsible for the intervention received detailed training before the start of the study to ensure their understanding and proper implementation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 10, 2024
• Study Start: June 1, 2019
• Primary Completion: May 13, 2021
• Study Completion: May 30, 2021
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)