Investigating swallowing difficulties after neck surgery
Impaired Swallowing Function After Anterior Cervical Spine Surgery- Incidence, Long-term Effect on Nutrition and Effect of Oral Neuromuscular Training
NA · Umeå University · NCT04855838
This study is testing how common swallowing difficulties are after neck surgery and whether a new training program can help improve swallowing compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Umeå University (other) |
| Locations | 1 site (Umeå) |
| Trial ID | NCT04855838 on ClinicalTrials.gov |
What this trial studies
This research project aims to assess the incidence of dysphagia, or impaired swallowing, following anterior cervical spine surgery (ACSS) and to evaluate its long-term impact on nutritional status. The study consists of two parts: the first is a prospective observational cohort study that tracks dysphagia incidence and related factors shortly after surgery and again 12 months later. The second part is a randomized trial comparing conventional care to a new oral neuromuscular training intervention for treating dysphagia. Participants will undergo swallowing assessments and nutritional screenings to gather comprehensive data.
Who should consider this trial
Good fit: Ideal candidates include adults who have undergone anterior cervical spine surgery due to trauma and are experiencing swallowing difficulties post-operation.
Not a fit: Patients under 18 years of age or those with pre-existing dysphagia or severe brain damage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for dysphagia, enhancing recovery and nutritional outcomes for patients after cervical spine surgery.
How similar studies have performed: While the approach of assessing dysphagia post-surgery is established, the specific intervention of oral neuromuscular training in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Umeå
- University Hospital of Umeå — Umeå, Sweden (RECRUITING)
Study contacts
- Principal investigator: Patricia Hägglund, PhD/SLP — Umeå University
- Study coordinator: Patricia Hägglund, PhD/SLP
- Email: patricia.hagglund@umu.se
- Phone: +46907850000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dysphagia, Cervical Spinal Cord Injury, Swallowing disorder, Anterior cervical spine surgery, Intervention, Incidens, Nutritional status