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Cervical Disc DiseaseACDF-REHABNCT07814950

Rehabilitation After Anterior Cervical Discectomy and Fusion

A study testing Structured Postoperative Rehabilitation Program and Standard Postoperative Follow-up in people with Cervical Disc Disease and Cervical Radiculopathy, run by Istanbul Medipol University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Anterior cervical discectomy and fusion (ACDF) is a commonly performed surgical procedure for cervical disc herniation, cervical radiculopathy, and degenerative cervical spine disorders. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Structured Postoperative Rehabilitation Program and Standard Postoperative Follow-up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Sep 2026to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mehmet Salih Tan, Assistant Professor, PhD contact

+90 546 726 68 76

mstan@medipol.edu.tr

About this study

Official title: Effects of Rehabilitation After Anterior Cervical Discectomy and Fusion on Dysphagia, Respiratory Muscle Strength, Neck Function, and Quality of Life: A Randomized Controlled 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.

Read more

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.

Read the 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.

Being tested
Structured Postoperative Rehabilitation Program, Standard Postoperative Follow-up
Keywords
Anterior Cervical Discectomy and Fusion, Postoperative Rehabilitation, Neck Disability, Quality of Life, Pulmonary Function
Medical subject headings
Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured Postoperative Rehabilitation ProgramOther

    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

  • Standard Postoperative Follow-upOther

    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.

Study groups in NCT07814950
Study groupRoleWhat they receive
Structured Rehabilitation GroupExperimentalParticipants will receive an 8-week structured postoperative rehabilitation program beginning during the first postoperative week. The program will be delivered three times per week for a total of 24 supervised sessions, with each session lasting approximately 45 to 60 minutes. Participants will also receive a daily home exercise program. Outcomes will be assessed at postoperative weeks 1, 4, and 8.
Receives: Other: Structured Postoperative Rehabilitation Program
Standard Postoperative Follow-up GroupActive comparatorParticipants will receive the standard postoperative recommendations provided by the surgical team. These recommendations may include wound care, cervical collar use when indicated, advice regarding daily activities, short-distance walking, and basic movements permitted by the surgeon. Participants will not receive the structured inspiratory muscle training, swallowing rehabilitation, or supervised cervical-scapular exercise program during the 8-week study period. Outcomes will be assessed at postoperative weeks 1, 4, and 8.
Receives: Other: Standard Postoperative Follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Postoperative week 1 (baseline), postoperative week 4, and postoperative week 8

Secondary outcomes (7)
  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.

    Measured: Postoperative week 1, postoperative week 4, and postoperative week 8

  2. 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.

    Measured: Postoperative week 1, postoperative week 4, and postoperative week 8

  3. 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.

    Measured: Postoperative week 1, postoperative week 4, and postoperative week 8

  4. 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.

    Measured: Postoperative week 1, postoperative week 4, and postoperative week 8

  5. Change in Neck Pain Intensity

    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.

    Measured: Postoperative week 1, postoperative week 4, and postoperative week 8

  6. Change in Neck Disability Index Score

    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.

    Measured: Postoperative week 1, postoperative week 4, and postoperative week 8

  7. Change in 36-Item Short Form Health Survey Scores

    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.

    Measured: Postoperative week 1, postoperative week 4, and postoperative week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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 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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07814950
Sponsor's protocol ID
ACDF-REHAB-2026-01
Acronym
ACDF-REHAB
Status last verified
Sep 2026
First submitted
6 Sep 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be made publicly available because of participant privacy and confidentiality considerations and because specific consent for external data sharing is not planned. Study findings will be reported in aggregate form in scientific publications and presentations.

Questions about this trial

What is this clinical trial studying?

A study testing Structured Postoperative Rehabilitation Program and Standard Postoperative Follow-up in people with Cervical Disc Disease and Cervical Radiculopathy, run by Istanbul Medipol University Hospital.

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 8 inclusion and 16 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mehmet Salih Tan, Assistant Professor, PhD (+90 546 726 68 76, mstan@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Eating Assessment Tool-10 Total Score (time frame: Postoperative week 1 (baseline), postoperative week 4, and postoperative week 8). 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 11 Sep 2026.

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