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NCT Number: NCT06202443

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tripler Army Medical Center, Honolulu, Hawaii, United States

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About this study

This study is a prospective randomized controlled trial of early PT (within 3 months after surgery) versus delayed PT (greater than 3 months after surgery) in adults following ACDF surgery for degenerative conditions. The central hypothesis is that an early PT program will be effective in improving disability, pain, physical function, opioid use and return to work/duty. 76 participants will be enrolled and randomized (38 patients per randomized group), with 64 (85%) expected to be retained in the trial at the 12-month follow-up. Eligible patients undergoing ACDF surgery for a degenerative condition will be randomized to one of two groups (early PT or delayed PT). Patients will be enrolled prior to surgery, asked to complete a preoperative questionnaire prior to surgery and then randomized. Patients randomized to one of the PT groups will have their first PT visit scheduled for them by study staff prior to surgery. This visit will occur at approximately 2 weeks after hospital discharge for the early PT group and approximately 3 months after hospital discharge for the delayed PT group. All randomized patients will be asked to participate in follow-up visits approximately 3-, 6- and 12-months after hospital discharge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early PT

Other

Physical therapy delivered within the first three months after surgery.

Delayed PT

Other

Physical therapy delivered greater than 3 months after surgery.

Primary outcomes

  1. Disability

    Time frame: 6 and 12 months after hospital discharge

    Neck Disability Index, 0-100 with higher scores indicating increased disability

Secondary outcomes

  1. Pain Intensity

    Time frame: 6 and 12 months after hospital discharge

    Numeric Rating Scale, 0-10 with higher scores indicating increased pain intensity

  2. Pain Interference

    Time frame: 6 and 12 months after hospital discharge

    PROMIS, 0-100 with higher scores indicating increased pain interference

  3. Physical Function

    Time frame: 6 and 12 months after hospital discharge

    PROMIS, 0-100 with higher scores indicating better physical function

  4. Opioid Utilization

    Time frame: 6 and 12 months after hospital discharge

    MMEs

  5. Return to work

    Time frame: 6 and 12 months after hospital discharge

    Work Productivity and Activity Impairment Questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Priest

CONTACT

[email protected]

615-421-8336

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Improving Surgical Outcomes With Early Physical Therapy After Anterior Cervical Discectomy and Fusion

Acronym: FAST-PT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 11, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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