Acupuncture Therapy on Dysphagia in Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Behavioral: Routine rehabilitation trainingBehavioral: Swallowing rehabilitation trainingProcedure: Acupuncture therapy
- Registration Number
- NCT06199323
- Lead Sponsor
- Zeng Changhao
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description routine treatment+swallowing rehabilitation training+acupuncture therapy Routine rehabilitation training The experimental group was given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy. routine treatment+swallowing rehabilitation training Routine rehabilitation training The control group was given routine treatment and swallowing rehabilitation training. routine treatment+swallowing rehabilitation training+acupuncture therapy Acupuncture therapy The experimental group was given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy. routine treatment+swallowing rehabilitation training+acupuncture therapy Swallowing rehabilitation training The experimental group was given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy. routine treatment+swallowing rehabilitation training Swallowing rehabilitation training The control group was given routine treatment and swallowing rehabilitation training.
- Primary Outcome Measures
Name Time Method Penetration-Aspiration Scale-liquid day 1 and day 42 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.Penetration-Aspiration Scale-paste day 1 and day 42 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.
- Secondary Outcome Measures
Name Time Method Swallowing time-The oral transit time-liquid day 1 and day 42 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.
Nutritional status-Hemoglobin day 1 and day 42 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).
Swallowing time-The oral transit time-paste day 1 and day 42 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.
Swallowing time-pharyngeal transit time-paste day 1 and day 42 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.
Swallowing time-pharyngeal transit time -liquid day 1 and day 42 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.
Nutritional status-Serum Albumin day 1 and day 42 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).
Swallowing time-swallowing reaction time-liquid day 1 and day 42 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.
Swallowing time-laryngeal closure duration-paste day 1 and day 42 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.
Nutritional status-Prealbumin day 1 and day 42 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).
Swallowing time-laryngeal closure duration-liquid day 1 and day 42 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.
Swallowing time-swallowing reaction time-paste day 1 and day 42 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.
Nutritional status-body mass index day 1 and day 42 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).Standardized Swallowing Assessment day 1 and day 42 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.
Trial Locations
- Locations (1)
Quanmi Hos.
🇨🇳Pingdong, Taiwan