Acupuncture Therapy on Dysphagia in Parkinson's Disease

Acupuncture Therapy on Dysphagia in Parkinson's Disease: A Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Routine rehabilitation training; Behavioral: Swallowing rehabilitation training; Procedure: Acupuncture therapy

Detailed Description

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. 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).

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Pingdong, Taiwan
    • Quanmi Hos.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Behavioral: Swallowing rehabilitation training; 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.; 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.; 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.; 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.; Procedure: 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).
Active Comparator: routine treatment+swallowing rehabilitation training; The control group was given routine treatment and swallowing rehabilitation training.	Behavioral: 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.; Behavioral: Swallowing rehabilitation training; 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.; 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing time-The oral transit time-liquid	The assessment was conducted under video fluoroscopic swallowing study. A 60% barium sulfate suspension was mixed with different doses of thickening agents. The liquid (60% barium sulfate suspension) was used. A shorter time indicated better swallowing function.	day 1 and day 42
Swallowing time-The oral transit time-paste	The assessment was conducted under video fluoroscopic swallowing study. A 60% barium sulfate suspension was mixed with different doses of thickening agents. The paste (180% barium sulfate suspension) was used. A shorter time indicated better swallowing function.	day 1 and day 42
Swallowing time-swallowing reaction time-liquid	The assessment was conducted under video fluoroscopic swallowing study. A 60% barium sulfate suspension was mixed with different doses of thickening agents. The liquid (60% barium sulfate suspension) was used. A shorter time indicated better swallowing function.	day 1 and day 42
Swallowing time-pharyngeal transit time -liquid	The assessment was conducted under video fluoroscopic swallowing study. A 60% barium sulfate suspension was mixed with different doses of thickening agents. The liquid (60% barium sulfate suspension) was used. A shorter time indicated better swallowing function.	day 1 and day 42
Swallowing time-laryngeal closure duration-liquid	The assessment was conducted under video fluoroscopic swallowing study. A 60% barium sulfate suspension was mixed with different doses of thickening agents. The liquid (60% barium sulfate suspension) was used. A shorter time indicated better swallowing function.	day 1 and day 42
Swallowing time-swallowing reaction time-paste	The assessment was conducted under video fluoroscopic swallowing study. A 60% barium sulfate suspension was mixed with different doses of thickening agents. The paste (180% barium sulfate suspension) was used. A shorter time indicated better swallowing function.	day 1 and day 42
Swallowing time-pharyngeal transit time-paste	The assessment was conducted under video fluoroscopic swallowing study. A 60% barium sulfate suspension was mixed with different doses of thickening agents. The paste (180% barium sulfate suspension) was used. A shorter time indicated better swallowing function.	day 1 and day 42
Swallowing time-laryngeal closure duration-paste	The assessment was conducted under video fluoroscopic swallowing study. A 60% barium sulfate suspension was mixed with different doses of thickening agents. The paste (180% barium sulfate suspension) was used. A shorter time indicated better swallowing function.	day 1 and day 42
Nutritional status-body mass index	Patients' body mass index was assessed with the physical check, with the combination of height and body weight. as kg/m^2, reference range: 18.5 kg/m2≤BMI<24 kg/m2. Values below the reference range for these indicators indicated an unsatisfying nutritional status (risk of malnutrition).	day 1 and day 42
Nutritional status-Serum Albumin	Patients' Serum Albumin was assessed from the routine blood test, reference range: 35~50 g/L.Values below the reference range for these indicators indicated an unsatisfying nutritional status (risk of malnutrition).	day 1 and day 42
Nutritional status-Prealbumin	Patients' Prealbumin was assessed from the routine blood test, reference range: 200~400 mg/L.Values below the reference range for these indicators indicated an unsatisfying nutritional status (risk of malnutrition).	day 1 and day 42
Nutritional status-Hemoglobin	Patients' Hemoglobin was assessed from the routine blood test, reference range: males: 120~160 g/L, females: 110~150 g/L. Values below the reference range for these indicators indicated an unsatisfying nutritional status (risk of malnutrition).	day 1 and day 42
Standardized Swallowing Assessment	The Standardized Swallowing Assessment (SSA) consists of three main parts: clinical examination, 5ml water swallow, and daily water intake assessment. The highest score is 46 points, the lowest is 18 points, with lower scores indicating better swallowing function.	day 1 and day 42

Collaborators and Investigators

• Sponsor: Zeng Changhao
• Investigators: Principal Investigator: Nieto Luis, Master, Site Coordinator of United Medical Group located in Miami

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): May 13, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2019-KS-HNSR008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the confidentiality regulations of the First Affiliated Hospital of Zhengzhou University, data cannot be publicly accessed, but can be obtained from the hospital's medical records for a suitable reason

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No