Acupuncture Therapy on Dysphagia in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-05-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Routine rehabilitation training

Intervention Type 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.

Swallowing rehabilitation training

Intervention Type 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.

Acupuncture therapy

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Routine rehabilitation training

Intervention Type 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.

Swallowing rehabilitation training

Intervention Type 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.

Interventions

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Routine rehabilitation training

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.

Intervention Type BEHAVIORAL

Swallowing rehabilitation training

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.

Intervention Type BEHAVIORAL

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).

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No