Swallowing Disorder.Other SpecifiedNCT07765043
Electromagnetic Therapy for Cervicogenic Dysphagia
A study testing The pulsed electromagnetic field treatment program plus the swallowing resistance training program in people with Swallowing Disorder.Other Specified, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Swallowing Disorder.Other Specified
- What is being tested?
- The pulsed electromagnetic field treatment program plus the swallowing resistance training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jul 2025to 25 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Electromagnetic Therapy in the Treatment of Cervicogenic Dysphagia: Randomized Single-blind Placebo-Control Study
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.
Read the detailed description
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.
- Conditions
- Swallowing Disorder.Other Specified
- Being tested
- The pulsed electromagnetic field treatment program plus the swallowing resistance training program, The placebo pulsed electromagnetic field treatment program plus the swallowing resistance training program
- Keywords
- Deglutition, Electromagnetic Therapy, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The pulsed electromagnetic field treatment program plus the swallowing resistance training programBehavioural
The pulsed electromagnetic field treatment program plus the swallowing resistance training program
The placebo pulsed electromagnetic field treatment program plus the swallowing resistance training programBehavioural
The placebo pulsed electromagnetic field treatment program plus the swallowing resistance training program
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: The placebo pulsed electromagnetic field treatment program plus the swallowing resistance training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing function
Assessment of the swallowing function using the Swallowing Disturbance Questionnaire, composed of 15 self-reported items.
Measured: Baseline and post-8 weeks
The dysphagia handicapping effects
The dysphagia handicapping effects assessment (using Dysphagia Handicap Index)
Measured: Baseline and post 8 weeks.
Secondary outcomes (2)
Pain intensity
Assessment of pain intensity using the 10 cm visual analog scale (VAS)
Measured: Baseline and post 8 weeks
The forward head position
The forward head position assessment (the craniovertebral angle)
Measured: Baseline and post 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Jul 2025
- Primary completion20 Mar 2026
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing Disorder.Other SpecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Abdelaal, Umm Al-Qura University
- Investigators
- ASHRAF AM ABDELAAL, Ph.D., Principal investigator, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765043
- Sponsor's protocol ID
- HAPO-02-K-012-2024-01-1956
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Required Institutional Ethical Committee approval first.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Electromagnetic Therapy in the Treatment of Cervicogenic Dysphagia: Randomized Single-blind Placebo-Control Study
- ClinicalTrials.gov ID
- NCT07765043
- Acronym / sponsor ID
- HAPO-02-K-012-2024-01-1956
- Conditions
- Swallowing Disorder.Other Specified
- Keywords
- Deglutition, Electromagnetic Therapy, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study group (received PEMFT + swallowing resistance training program; n=20) | Experimental | Behavioral: The pulsed electromagnetic field treatment program plus the swallowing resistance training programParticipants 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). |
| Control group (received placebo PEMFT + swallowing resistance training program; n=20) | Placebo comparator | Behavioral: The placebo pulsed electromagnetic field treatment program plus the swallowing resistance training programParticipants 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). |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The pulsed electromagnetic field treatment program plus the swallowing resistance training programThe pulsed electromagnetic field treatment program plus the swallowing resistance training program | Behavioural | Study group (received PEMFT + swallowing resistance training program; n=20) |
| The placebo pulsed electromagnetic field treatment program plus the swallowing resistance training programThe placebo pulsed electromagnetic field treatment program plus the swallowing resistance training program | Behavioural | Control group (received placebo PEMFT + swallowing resistance training program; n=20) |
Primary outcome
Swallowing function
Time frame: 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
Time frame: Baseline and post 8 weeks.
The dysphagia handicapping effects assessment (using Dysphagia Handicap Index)
2 secondary outcomes
Pain intensity
Time frame: Baseline and post 8 weeks
The forward head position
Time frame: Baseline and post 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No. Required Institutional Ethical Committee approval first.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ASHRAF AM ABDELAAL, Ph.D. principal investigator
Umm Al-Qura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The pulsed electromagnetic field treatment program plus the swallowing resistance training program in people with Swallowing Disorder.Other Specified, run by Umm Al-Qura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing function (time frame: Baseline and post-8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.