- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07765043
Electromagnetic Therapy for Cervicogenic Dysphagia
Efficacy of Electromagnetic Therapy in the Treatment of Cervicogenic Dysphagia: Randomized Single-blind Placebo-Control Study
연구 개요
상태
상세 설명
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.
Low-frequency, low-intensity electromagnetic field therapy (EMT) is a safe, non-invasive therapeutic modality of clinical interest and effective applicability in the treatment of a variety of pathologies.
Although the effectiveness of pulsed electromagnetic field therapy (PEMFT) as a safe and effective therapeutic modality was investigated in a variety of cervical pathologies, there is a lack of evidence supporting the effectiveness of PEMFT in the treatment of patients with cervicogenic dysphagia.
Considering the reported safety and effectiveness of PEMFT therapy in the treatment of different pathologies, this study aimed to investigate the effects of PEMFT therapy on swallowing function and the dysphagia handicapping effects in patients with CD.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Mecca, 사우디 아라비아, 24351
- Umm Al-Qura University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Study group (received PEMFT + swallowing resistance training program; n=20)
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).
|
The pulsed electromagnetic field treatment program plus the swallowing resistance training program
|
|
위약 비교기: Control group (received placebo PEMFT + swallowing resistance training program; n=20)
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).
|
The placebo pulsed electromagnetic field treatment program plus the swallowing resistance training program
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Swallowing function
기간: Baseline and post-8 weeks
|
Assessment of the swallowing function using the Swallowing Disturbance Questionnaire, composed of 15 self-reported items.
|
Baseline and post-8 weeks
|
|
The dysphagia handicapping effects
기간: Baseline and post 8 weeks.
|
The dysphagia handicapping effects assessment (using Dysphagia Handicap Index)
|
Baseline and post 8 weeks.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain intensity
기간: Baseline and post 8 weeks
|
Assessment of pain intensity using the 10 cm visual analog scale (VAS)
|
Baseline and post 8 weeks
|
|
The forward head position
기간: Baseline and post 8 weeks
|
The forward head position assessment (the craniovertebral angle)
|
Baseline and post 8 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: ASHRAF AM ABDELAAL, Ph.D., Umm Al-Qura University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .