Acupuncture Therapy on Dysphagia in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06199323
• Other study ID #: 2019-KS-HNSR008
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: March 2024
• Source: People's Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: May 30, 2021
• Est. primary completion date: May 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• 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).

Locations

Country	Name	City	State
Taiwan	Quanmi Hos.	Pingdong

Sponsors (1)

Lead Sponsor	Collaborator
Zeng Changhao

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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