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Rehabilitation After Anterior Cervical Discectomy and Fusion (ACDF-REHAB)

6 de setembro de 2026 atualizado por: salih tan, Istanbul Medipol University Hospital

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.

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Mehmet Salih Tan, Assistant Professor, PhD
  • Número de telefone: +90 546 726 68 76
  • E-mail: mstan@medipol.edu.tr

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Structured Rehabilitation Group
Participants 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.

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

Comparador Ativo: Standard Postoperative Follow-up Group
Participants 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.
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Eating Assessment Tool-10 Total Score
Prazo: 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.
Postoperative week 1 (baseline), postoperative week 4, and postoperative week 8

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Bazaz Dysphagia Grade
Prazo: 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.
Postoperative week 1, postoperative week 4, and postoperative week 8
Change in Functional Oral Intake Scale Score
Prazo: 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.
Postoperative week 1, postoperative week 4, and postoperative week 8
Change in Maximal Inspiratory Pressure
Prazo: 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.
Postoperative week 1, postoperative week 4, and postoperative week 8
Change in Maximal Expiratory Pressure
Prazo: 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.
Postoperative week 1, postoperative week 4, and postoperative week 8
Change in Neck Pain Intensity
Prazo: 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.
Postoperative week 1, postoperative week 4, and postoperative week 8
Change in Neck Disability Index Score
Prazo: 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.
Postoperative week 1, postoperative week 4, and postoperative week 8
Change in 36-Item Short Form Health Survey Scores
Prazo: 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.
Postoperative week 1, postoperative week 4, and postoperative week 8

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de outubro de 2026

Conclusão do estudo (Estimado)

1 de novembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

6 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de setembro de 2026

Primeira postagem (Real)

11 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • ACDF-REHAB-2026-01

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .