NCT07765043

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

DeglutitionElectromagnetic TherapyExercise

Outcome Measures

Primary Outcomes (2)

  • Swallowing function

    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

    The dysphagia handicapping effects assessment (using Dysphagia Handicap Index)

    Baseline and post 8 weeks.

Secondary Outcomes (2)

  • Pain intensity

    Baseline and post 8 weeks

  • The forward head position

    Baseline and post 8 weeks

Study Arms (2)

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).

Behavioral: The pulsed electromagnetic field treatment program plus the swallowing resistance training program

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).

Behavioral: The placebo pulsed electromagnetic field treatment program plus the swallowing resistance training program

Interventions

The pulsed electromagnetic field treatment program plus the swallowing resistance training program

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

The placebo pulsed electromagnetic field treatment program plus the swallowing resistance training program

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

Eligibility Criteria

Age50 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Subjects diagnosed with rheumatological disease, cerebrovascular abnormalities, having a metal implant or previous cervical surgeries, or having received any 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), those who received medications interfering with normal swallowing function (e.g., antiepileptics, antipsychotics, and antidepressant drugs), and subjects who refused to provide the signed informed consent were all excluded at the beginning of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umm Al-Qura University

Mecca, 24351, Saudi Arabia

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • ASHRAF AM ABDELAAL, Ph.D.

    Umm Al-Qura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This interventional study aimed to investigate the effects of Low-frequency, low-intensity electromagnetic field therapy on swallowing function and the dysphagia handicapping effects in patients with Cervicogenic dysphagia (CD). Forty participants matched the inclusion criteria, provided informed consent agreeing to participate in the study and publication of its results, and were randomly allocated to either the study group (received PEMFT + swallowing resistance training program "SRTP"; n=20) or the control group (received placebo PEMFT + SRTP; n=20). The study primary outcomes (swallowing function and dysphagia handicapping effect) and the secondary outcomes (pain and forward head position) were evaluated at the beginning and at the end of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 14, 2026

Study Start

July 1, 2025

Primary Completion

March 20, 2026

Study Completion

May 25, 2026

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Required Institutional Ethical Committee approval first.

Locations