Rehabilitation After Anterior Cervical Discectomy and Fusion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIstanbul Medipol University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Structured Postoperative Rehabilitation Program
Other interventionThe 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
Standard Postoperative Follow-up
Other interventionParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Structured Rehabilitation GroupExperimental treatment 1 intervention
Group B: Standard Postoperative Follow-up GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Eating Assessment Tool-10 Total Score
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.
Time frame
Postoperative week 1 (baseline), postoperative week 4, and postoperative week 8Secondary outcomes
1
Change in Bazaz Dysphagia Grade
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.
Time frame
Postoperative week 1, postoperative week 4, and postoperative week 82
Change in Functional Oral Intake Scale Score
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.
Time frame
Postoperative week 1, postoperative week 4, and postoperative week 83
Change in Maximal Inspiratory Pressure
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.
Time frame
Postoperative week 1, postoperative week 4, and postoperative week 84
Change in Maximal Expiratory Pressure
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.
Time frame
Postoperative week 1, postoperative week 4, and postoperative week 8Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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