UnknownNot Applicable

Physiotherapy After Anterior Cervical Spine Surgery

Sweden20 participantsStarted 2017-05-22

Plain-language summary

Background: Patients suffering residual disability after anterior decompression and fusion (ACDF) surgery for cervical disc disease may be prescribed physical activity (PPA) or neck-specific exercises (NSE). Currently, we lack data for the success of either approach. There is also a knowledge-gap concerning the use of internet-based care for chronic neck pain, inclusive of cervical disc disease. The scarcity of these data, and the high proportion of patients with various degrees of incapacity following ACDF, warrants increased efforts to investigate and improve cost-effective rehabilitation. Objective: To investigate the effectiveness of a structured, internet-based NSE program, versus PPA following ACDF surgery. Methods: This is a prospective, randomised, experimental, longitudinal multicentre study, that includes 140 patients with residual disability (≥30% on the Neck Disability Index; NDI) following ACDF for radiculopathy due to cervical disc disease. Patient recruitment occurs following attendance at routine clinical appointments, scheduled for 3-months post-surgery. Patients are then randomised to one of two groups (70 patients/group), scheduled for a 3-month treatment of either internet-based NSE or PPA. Questionnaires on background data, pain and discomfort, physical and mental capacity, satisfaction with care, and health and workplace factors are completed, with physical measurements of neck-related function performed by independent test leaders blinded to randomisation. Measurements are performed at inclusion, after the 3-month treatments (end of treatment), and at a 2-year follow-up. Radiography will be completed at the 2-year follow-up. Preoperative data will be collected from the Swedish Spine Registry (Swespine). Data on healthcare consumption, drug use, and sick leave will be requested from the relevant national registers.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Inclusion criteria for each surgical department: • Record data in Swespine Inclusion criteria for surgery: * Cervical disc disease, confirmed by MRI data compatible with clinical findings (neurological examination performed by neck surgeon i.e. neurosurgeon/orthopaedic surgeon) that show nerve root compression in the cervical spine. * Radiculopathy with pain in one or both arms, with or without sensory and/or motor deficit * At least 3 months of persistent arm pain Inclusion criteria for the study: * ACDF due to cervical disc disease (disc herniation with or without osteophytes, or stenosis caused by osteophytes) in one or two segmental levels * Aged 18-75 years * Residual disability (approximately) 3 months after surgery (at the re-visit to the surgeon/ physiotherapist at the neurosurgery/ neuroorthopedic clinic) in terms of the Neck Disability Index (NDI ≥30%). * Access to a computer/tablet/smartphone and the Internet * Motivated to exercise Exclusion Criteria: Exclusion criteria: * Myelopathy * Previous fracture or dislocation of the cervical spine * Malignancy or benign spinal tumour (e.g. neuromas) * Spinal infection, ongoing post-operative infection, or previous spondylodiscitis * Previous cervical spine surgery * Factors that are contraindicated for study participation or which hinder treatment or follow-up because of systemic disease, physical or mental illness, injury, inconvenience, or postoperative complications. * Known alcohol/drug ab…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neck Disability Index (NDI)

Timeframe: Change from baseline to 3 months (the end of treatment) and 24 months follow-up. Preoperative data from the Swespine register

Trial details

NCT IDNCT03036007

SponsorLinkoeping University

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Cervical Disc Disease trials