Effect of Acupuncture Therapy on Dysphagic Parkinson's Patients
- Conditions
- Dysphagia
- Interventions
- Behavioral: Routine rehabilitation trainingBehavioral: Swallowing rehabilitation trainingProcedure: Acupuncture therapy
- Registration Number
- NCT06255756
- Lead Sponsor
- Zeng Changhao
- Brief Summary
We are currently conducting a randomized controlled study in China, specifically in three hospitals' rehabilitation medicine departments, 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.
- Detailed Description
We are currently conducting a randomized controlled study in China, specifically in three hospitals' rehabilitation medicine departments, 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.
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
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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+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 Routine rehabilitation training The control group was given routine treatment and swallowing rehabilitation training. routine treatment+swallowing rehabilitation training Swallowing 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.
- Primary Outcome Measures
Name Time Method 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.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.
- Secondary Outcome Measures
Name Time Method Swallowing time 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.
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).
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 Quality of Life Day 1 and Day 42 Swallowing Quality of Life (SWAL-QOL) is a questionnaire designed to evaluate the impact of swallowing problems on a patient's quality of life. It includes 44 items covering various aspects such as eating desire, food selection, communication, and mental health.
The SWAL-QOL total score ranges from 0 to 100, with higher scores indicating better quality of life. Therefore, in this case, the higher the score, the better the individual's quality of life related to their swallowing function.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).
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.
Trial Locations
- Locations (1)
Zheng Da yi Yuan Hospital
🇨🇳Zhenzhou, Henan, China