Dysphagia After Anterior Cervical Spine Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUmeå University
About this trial
The purpose of this research project is to investigate the incidence of impaired swallowing (dysphagia) after anterior cervical spine surgery (ACSS) and to study the long-term effect of dysphagia on nutritional status 12 ± 3 months later. Furthermore, to investigate the effect of a new rehabilitation method for dysphagia among individuals with swallowing dysfunction after ACSS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients enrolled at the University Hospital of Umeå who have undergone ACSS between C2 and Th1 level due to trauma are eligible participants in the first part of the study.
Eligibility criteria to participate in part 2 is swallowing dysfunction on FEES at 4±1-week post-operation
Disqualifiers
Patients <18 years of age
known dysphagia prior to the trauma/injury
affected brainstem that is shown on a CT or MRI
severe brain damage.
Trial design
Design model
Parallel
Treatments tested in this trial
Oral neuromuscular training
DeviceThe oral device is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial and pharyngeal muscles.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Dysphagia severity
Change in swallowing function measured by FEES.
Time frame
At start, at 4 weeks into the training, at end of treatment (after 8 weeks) and 12 ± 3 months post-interventionSecondary outcomes
1
Swallowing ability
Change in swallowing ability measured by the FOIS (functional oral intake scale)
Time frame
At start, at 4 weeks into the training, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention2
Swallowing related quality of life
Change in quality of life related to swallowing measured by the SWAL-QOL questionnaire.
Time frame
At start, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention3
Nutritional status
Changes in nutritional status measured by the NRS-2002
Time frame
At start, at end of treatment (after 8 weeks) and 12 ± 3 months post-intervention4
Nutritional and metabolic status
Changes in nutritional status measured by blood samples (i.e., levels of Albumin, levels of Leptin, Ghrelin and Adiponektin and also metabolites as ketone bodies)
Time frame
At start, at end of treatment (after 8 weeks) and 12 ± 3 months post-interventionSponsors and contacts
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Umeå University
Lead sponsor
University Hospital, Umeå
Collaborator
Source ClinicalTrials.gov