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临床试验/NCT07765043
NCT07765043已完成不适用

Efficacy of Electromagnetic Therapy in the Treatment of Cervicogenic Dysphagia: Randomized Single-blind Placebo-Control Study

Umm Al-Qura University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Swallowing function

研究概览

简要总结

Cervicogenic dysphagia (CD) is a swallowing disorder in patients with cervicogenic pathology. Pulsed electromagnetic therapy (PEMT) is a widely utilized therapeutic modality. Objective: To investigate the effects of PEMT on swallowing function (SF) and dysphagia handicapping effects in patients with CD. Methods: 40 volunteer participants (50-60 years old) with CD and cervical spondylosis were randomly and equally assigned to the study group (PEMT+swallowing resistance training program "SRTP") and control group (placebo PEMT+SRTP). Intervention: All participants received 3 sessions of SRTP (resisted chin tuck-in and resisted swallowing exercises) and 2 PEMT sessions (20 minutes of 20 Hz low frequency, 0.8 milli Tesla low intensity) per week for 8 weeks. Outcome Measures: The SF was evaluated using the swallow difficulty questionnaire "SDQ", and the dysphagia handicapping effects were evaluated using the dysphagia handicap index (DHI) pre-and post-study. Statistical analysis: Within-group comparisons were done using a paired t-test, and the between-group differences were examined using two-way ANOVA; a significant value was set at P<0.05.

详细描述

Swallowing represents an integrated sensorimotor process accomplished by coordinated muscular actions. Cervical spine structures, under normal conditions, play an important role in maintaining coordinated swallowing.

The muscular and neural structures of the cervical spine are responsible for the coordinated movement of the larynx, pharynx, and hyoid bone during swallowing. Sensory information ascends from cervical structures to the brainstem, providing feedback to help synchronize the complex and harmonized contributions of the neck and throat muscles during swallowing. Disruption of this sensory feedback loop can result in coordination deficits and difficulty swallowing.

Biomechanical alterations or degenerative changes in the cervical spine can affect its position and stability. These alterations may further impact the surrounding neural and muscular structures' functions, resulting in a variety of alarming symptoms and dysfunctional patterns that predispose to mechanical obstruction and difficulty swallowing.

Cervicogenic dysphagia (CD) is an alarming disorder characterized by disturbed swallowing secondary to cervical structures dysfunction. Cervical spondylosis and associated pathological consequences can contribute to the development of CD. Cervical spine biomechanical alterations and malalignments, such as cervical kyphosis, a condition commonly encountered in cervical spondylosis, can predispose to pharyngeal dysfunction and difficult swallowing. The combined effects of neck muscular and articular dysfunctions represented in muscle weakness, poor cervical posture, and limited range of motion can disturb the cricopharyngeal sphincter action and the normal laryngeal function, ultimately predisposing to CD.

Although cure of dysphagia is not always possible, conservative approaches can provide an effective path to alleviate patients' complaints. A comprehensive dysphagia management program is not only important to restore normal swallowing function, but also to eliminate the economic burden and the dysphagia-related health hazards.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

This study followed the pre-posttest, randomized, single-blind, parallel arm, placebo-controlled study design. All participants were blind to the PEMFT treatment (participants were not oriented towards the PEMFT, whether actual or placebo); assessors were blind to the groups' allocation and the received treatment, groups' allocation and study design.

入排标准

年龄范围
50 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals diagnosed with cervicogenic dysphagia and cervical spondylosis
  • •Age 50-60 years.
  • •Individuals with a sedentary lifestyle (less than 30 minutes of aerobic activities per day).
  • •Signed the written consent

排除标准

  • •Subjects diagnosed with rheumatological disease, cerebrovascular abnormalities
  • •Subjects having a metal implant or previous cervical surgeries.
  • •Subjects having received physical therapy programs for cervical spondylosis or dysphagia within the last 6 months.
  • •Subjects with recent infection, cognitive impairments or dementia, cardiovascular instability, head or neck traumatic injuries, neurological disorders affecting swallowing (e.g., parkinsonism, stroke).
  • •Subjects who received medications interfering with normal swallowing function (e.g., antiepileptics, antipsychotics, and antidepressant drugs).
  • •Subjects who refused to provide the signed informed consent.

研究组 & 干预措施

Control group (received placebo PEMFT + swallowing resistance training program; n=20)

Placebo Comparator

Participants in the control (Placebo comparator) group received the placebo PEMFT treatment program in addition to the swallowing resistance training program "SRTP (which included the resisted chin tuck-in and the resisted swallowing exercises).

干预措施: The placebo pulsed electromagnetic field treatment program plus the swallowing resistance training program (Behavioral)

Study group (received PEMFT + swallowing resistance training program; n=20)

Experimental

Participants in the study group received the PEMFT treatment program in addition to the swallowing resistance training program "SRTP (which included the resisted chin tuck-in and the resisted swallowing exercises).

干预措施: The pulsed electromagnetic field treatment program plus the swallowing resistance training program (Behavioral)

结局指标

主要结局

Swallowing function

时间窗: Baseline and post-8 weeks

Assessment of the swallowing function using the Swallowing Disturbance Questionnaire, composed of 15 self-reported items.

The dysphagia handicapping effects

时间窗: Baseline and post 8 weeks.

The dysphagia handicapping effects assessment (using Dysphagia Handicap Index)

次要结局

  • Pain intensity(Baseline and post 8 weeks)
  • The forward head position(Baseline and post 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashraf Abdelaal

Associate Professor

Umm Al-Qura University

研究点 (1)

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