RecruitingNot Applicable

Function After Anterior Cervical Discectomy and Fusion Surgery: Timing of Physical Therapy

United States76 participantsStarted 2024-02-01

Plain-language summary

The goal of this two-group randomized clinical trial is to examine the effects of early postoperative PT compared to delayed postoperative PT for improving outcomes after hospital discharge for ACDF surgery. The main question this clinical trial aims to answer are: * Whether early PT participants will demonstrate greater improvements in outcomes compared to delayed PT participants. * Whether improvements in handgrip strength, cervical endurance, and cervical range of motion will be associated with improvements in outcomes. Participants will be randomized to one of two groups (early PT or delayed PT) and outcomes compared across groups.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

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

Inclusion Criteria: * Surgical treatment of a cervical degenerative condition using a 1- or 2-level ACDF procedure; * English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and * Age 18-75 years of age (individuals older than 75 are more likely to experience respiratory and nervous system complications and death following ACDF) Exclusion Criteria: * Surgery secondary to trauma, fracture, tumor, infection, or spinal deformity; * Undergoing cervical corpectomy; * Prior history of cervical spine surgery in last 5 years; * Diagnosis or presence of osteoporosis; * Diagnosis or presence of severe psychiatric disorder such as schizophrenia or bipolar disorder; * Documented history of alcohol and/or drug abuse; * Currently involved in litigation due to injury; * Currently undergoing treatment for cancer; * Patients not able to return for follow-up visits due to time and travel limitation or other reasons; and * Unable to provide a stable telephone or physical address

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

Disability

Timeframe: 6 and 12 months after hospital discharge

Trial details

NCT IDNCT06202443

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Amanda Priest

615-421-8336 amanda.priest@vumc.org

View on ClinicalTrials.gov More Cervical Spine Degeneration trials