Cervical Disc Disease, Cervical Radiculopathy, Postoperative Dysphagia
Conditions
Keywords
Anterior Cervical Discectomy and Fusion, Postoperative Rehabilitation, Neck Disability, Quality of Life, Pulmonary Function
Brief summary
Anterior cervical discectomy and fusion (ACDF) is a commonly performed surgical procedure for cervical disc herniation, cervical radiculopathy, and degenerative cervical spine disorders. Although surgery may reduce pain and neurological symptoms, some patients experience swallowing difficulties, neck pain, restricted neck movement, reduced respiratory muscle strength, and impaired quality of life after surgery. The purpose of this randomized controlled study is to determine whether a structured postoperative rehabilitation program improves swallowing function, respiratory muscle strength, pulmonary function, neck-related disability, pain, cervical range of motion, and health-related quality of life in adults who have undergone single- or two-level ACDF. A total of 60 eligible participants will be randomly assigned in a 1:1 ratio to either a structured rehabilitation group or a standard postoperative follow-up group. The structured program will include breathing exercises, inspiratory muscle training, swallowing and safe feeding education, cervical and scapular exercises, postural training, upper-extremity exercises, walking, and gradual physical activity. Participants in the control group will receive the standard postoperative recommendations provided by the surgical team. Assessments will be conducted before the rehabilitation program and during postoperative follow-up. The primary outcome will be swallowing difficulty measured using the Eating Assessment Tool-10. Additional outcomes will include dysphagia severity, oral intake level, respiratory muscle strength, spirometric pulmonary function, neck pain, neck-related disability, cervical range of motion, health-related quality of life, treatment adherence, and adverse events.
Detailed description
This study is planned as a prospective, single-center, assessor-blinded, parallel-group randomized controlled clinical trial. The study will include 60 adults aged 18 to 70 years who have undergone elective single- or two-level anterior cervical discectomy and fusion (ACDF) for degenerative cervical disc disease, cervical disc herniation, and/or cervical radiculopathy. After postoperative clinical stabilization and approval for rehabilitation by the responsible surgeon, eligible participants who provide written informed consent will be randomly assigned in a 1:1 ratio to one of two groups: a structured rehabilitation group or a standard postoperative follow-up group. A computer-generated randomization sequence will be prepared by an independent researcher who is not involved in outcome assessment. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. Because of the nature of the intervention, participants and the treating physiotherapist cannot be blinded. However, outcome assessments will be conducted by a physiotherapist who is blinded to group allocation. The structured rehabilitation program will be delivered under physiotherapist supervision and supported by a daily home exercise program. The program will include diaphragmatic breathing, thoracic expansion and breathing control exercises, inspiratory muscle training, controlled expiration and coughing techniques, safe swallowing and feeding-position education, individualized oropharyngeal exercises, cervical neutral-position and posture training, scapular stabilization, low-intensity deep cervical flexor activation, pain-free cervical range-of-motion exercises within surgeon-approved limits, upper-extremity mobility and stretching exercises, walking, and gradually increased physical activity. Inspiratory muscle training will begin at approximately 30% of the participant's baseline maximal inspiratory pressure. Training intensity may be increased according to participant tolerance, perceived exertion, and clinical findings. Swallowing rehabilitation will be individualized according to dysphagia severity. Participants with marked dysphagia, suspected aspiration, or coughing during swallowing will be referred for appropriate specialist assessment. All cervical exercises will comply with the postoperative restrictions established by the surgeon. Participants assigned to the control group will receive the surgical team's standard postoperative recommendations, including wound care, cervical collar use when indicated, advice regarding daily activities, short-distance walking, and basic permitted movements. They will not receive the structured inspiratory muscle training, swallowing rehabilitation, or supervised cervical-scapular exercise program during the study period. Any additional treatment received outside the study will be documented. The primary outcome will be swallowing-related symptoms measured using the Eating Assessment Tool-10 (EAT-10). Secondary outcomes will include the Bazaz Dysphagia Grading System, Functional Oral Intake Scale, maximal inspiratory and expiratory pressures, forced vital capacity, forced expiratory volume in one second, FEV1/FVC ratio, peak expiratory flow, Numerical Rating Scale for pain, Neck Disability Index, cervical range of motion, and the 36-Item Short Form Health Survey. Treatment adherence, additional treatments, postoperative complications, and adverse events will also be recorded. Outcomes will be assessed before the rehabilitation program and during postoperative follow-up. The principal analysis will compare changes over time between the structured rehabilitation and standard follow-up groups. The study will also examine the relationships between changes in dysphagia, respiratory muscle strength, neck function, pain, and health-related quality of life.
Interventions
The structured rehabilitation program will be administered under the supervision of a physiotherapist three times per week for 8 weeks, for a total of 24 sessions. Each session will last approximately 45 to 60 minutes. The program will include diaphragmatic breathing, controlled thoracic expansion, segmental breathing, breathing awareness, inspiratory muscle training, controlled expiration and coughing techniques, safe swallowing and feeding-position education, individualized oropharyngeal exercises, postural training, scapular stabilization, low-intensity deep cervical flexor activation, pain-free cervical range-of-motion exercises within surgeon-approved limits, upper-extremity mobility and stretching exercises, walking, and gradually increased physical activity. Inspiratory muscle training will begin at approximately 30% of the participant's baseline maximal inspiratory pressure and may be progressively increased according to tolerance, perceived exertion, and clinical findings. P
OTHERStandard Postoperative Follow-up
Participants will receive routine postoperative recommendations from the surgical team, including wound care, cervical collar use when indicated, guidance regarding activities of daily living, short-distance walking, and basic movements permitted by the surgeon. No structured inspiratory muscle training, swallowing rehabilitation, or supervised cervical-scapular rehabilitation program will be provided during the 8-week study period. Any additional treatment received outside the study will be documented.
Sponsors
Istanbul Medipol University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the rehabilitation intervention, participants and treating physiotherapists cannot be masked. Outcome assessments will be performed by a physiotherapist who is blinded to group allocation. Participants will be instructed not to disclose their group assignment to the outcomes assessor.
Intervention model description
This is a prospective, single-center, assessor-blinded, parallel-group randomized controlled trial. Eligible participants will be randomly assigned in a 1:1 ratio to either a structured postoperative rehabilitation group or a standard postoperative follow-up group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-70 years * Having undergone elective single- or two-level ACDF for degenerative cervical disc disease, disc herniation, and/or cervical radiculopathy * Being clinically and hemodynamically stable after surgery * Having the surgeon's approval for rehabilitation * Being able to understand Turkish and follow instructions * Being able to walk independently or with an assistive device * Having sufficient cognitive ability to participate * Providing written informed consent
Exclusion criteria
* Fusion involving three or more cervical levels * Cervical surgery for trauma, tumor, infection, rheumatoid arthritis, or congenital deformity * Previous anterior cervical surgery or revision surgery * Posterior or combined cervical surgery * Tracheostomy * Severe preoperative dysphagia or neurological swallowing disorder * Neurological disease affecting swallowing * Uncontrolled cardiovascular or pulmonary disease * Advanced COPD, uncontrolled asthma, or active respiratory infection * Contraindication to inspiratory muscle training * Active malignancy or systemic infection * Severe cognitive, psychiatric, hearing, or communication disorder * New postoperative neurological deficit * Wound infection, implant complication, or need for additional surgery * Participation in another structured neck or respiratory rehabilitation program * Any condition preventing regular participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Eating Assessment Tool-10 Total Score | Postoperative week 1 (baseline), postoperative week 4, and postoperative week 8 | Swallowing-related symptoms will be assessed using the Eating Assessment Tool-10 (EAT-10), a 10-item patient-reported questionnaire. Each item is scored from 0 (no problem) to 4 (severe problem), providing a total score ranging from 0 to 40. Higher scores indicate more severe swallowing-related symptoms. A total score of 3 or higher indicates abnormal swallowing-related symptoms. The primary comparison will be the change in the EAT-10 total score from postoperative week 1 to postoperative week 8 between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bazaz Dysphagia Grade | Postoperative week 1, postoperative week 4, and postoperative week 8 | Dysphagia severity will be classified using the Bazaz Dysphagia Grading System. Swallowing difficulty for solid and liquid foods is classified into four categories: none (0), mild (1), moderate (2), or severe (3). Higher grades indicate more severe dysphagia. |
| Change in Functional Oral Intake Scale Score | Postoperative week 1, postoperative week 4, and postoperative week 8 | Functional oral intake will be assessed using the Functional Oral Intake Scale (FOIS). The scale ranges from level 1 (no oral intake) to level 7 (total oral intake without restrictions). Higher scores indicate greater functional oral intake and independence. |
| Change in Maximal Inspiratory Pressure | Postoperative week 1, postoperative week 4, and postoperative week 8 | Inspiratory muscle strength will be assessed by maximal inspiratory pressure using a portable respiratory pressure measurement device. At least three acceptable measurements will be performed, and the highest acceptable value will be recorded in centimeters of water (cmH2O). Higher values indicate greater inspiratory muscle strength. |
| Change in Maximal Expiratory Pressure | Postoperative week 1, postoperative week 4, and postoperative week 8 | Expiratory muscle strength will be assessed by maximal expiratory pressure using a portable respiratory pressure measurement device. At least three acceptable measurements will be performed, and the highest acceptable value will be recorded in centimeters of water (cmH2O). Higher values indicate greater expiratory muscle strength. |
| Change in Neck Pain Intensity | Postoperative week 1, postoperative week 4, and postoperative week 8 | Neck pain intensity at rest and during activity will be assessed using an 11-point Numerical Rating Scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. |
| Change in Neck Disability Index Score | Postoperative week 1, postoperative week 4, and postoperative week 8 | Neck-related disability will be assessed using the Neck Disability Index. The questionnaire contains 10 sections, each scored from 0 to 5, providing a total score ranging from 0 to 50. Higher scores indicate greater neck-related disability. |
| Change in 36-Item Short Form Health Survey Scores | Postoperative week 1, postoperative week 4, and postoperative week 8 | Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The instrument evaluates eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Each domain is transformed to a score ranging from 0 to 100, with higher scores indicating better health-related quality of life. |
Contacts
CONTACTMehmet Salih Tan, Assistant Professor, PhD
Outcome results
None listed