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

NCT06202443 | Recruiting

• 1 other identifier: 231031
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cervical Spine Degeneration; ACDF Surgery

Outcome Measures

Primary Outcomes (1)

• Disability

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

  6 and 12 months after hospital discharge

Secondary Outcomes (5)

• Pain Intensity

  6 and 12 months after hospital discharge

• Pain Interference

  6 and 12 months after hospital discharge

• Physical Function

  6 and 12 months after hospital discharge

• Opioid Utilization

  6 and 12 months after hospital discharge

• Return to work

  6 and 12 months after hospital discharge

Study Arms (2)

Early Physical Therapy (PT)

EXPERIMENTAL

PT will be delivered two times a week for 8 weeks by a licensed physical therapist. Participants will start PT approximately 2 weeks after hospital discharge

Other: Early PT

Delayed Physical Therapy (PT)

ACTIVE COMPARATOR

PT will be delivered two times a week for 8 weeks by a licensed physical therapist. Participants will start PT approximately 3 months after hospital discharge.

Other: Delayed PT

Interventions

Early PT OTHER

Physical therapy delivered within the first three months after surgery.

Early Physical Therapy (PT)

Delayed PT OTHER

Physical therapy delivered greater than 3 months after surgery.

Delayed Physical Therapy (PT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (4)

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

Booke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

RECRUITING

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

RECRUITING

Related Publications (2)

• Coronado RA, Devin CJ, Pennings JS, Aaronson OS, Haug CM, Van Hoy EE, Vanston SW, Archer KR. Safety and feasibility of an early telephone-supported home exercise program after anterior cervical discectomy and fusion: a case series. Physiother Theory Pract. 2021 Oct;37(10):1096-1108. doi: 10.1080/09593985.2019.1683921. Epub 2019 Oct 30.

  PMID: 31663795 BACKGROUND

• Coronado RA, Devin CJ, Pennings JS, Vanston SW, Fenster DE, Hills JM, Aaronson OS, Schwarz JP, Stephens BF, Archer KR. Early Self-directed Home Exercise Program After Anterior Cervical Discectomy and Fusion: A Pilot Study. Spine (Phila Pa 1976). 2020 Feb 15;45(4):217-225. doi: 10.1097/BRS.0000000000003239.

  PMID: 31490861 BACKGROUND

Study Officials

• Kristin Archer, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Priest

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 11, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)