Improving Surgical Outcomes With Early PT After ACDF

February 12, 2024 updated by: Kristin Archer, Vanderbilt University Medical Center

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

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 cervical strength and 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Not yet recruiting
        • Booke Army Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel Rhon, PhD
    • Washington
      • Tacoma, Washington, United States, 98431
        • Not yet recruiting
        • Madigan Army Medical Center
        • Principal Investigator:
          • Daniel Rhon, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Physical Therapy (PT)
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
Physical therapy delivered within the first three months after surgery.
Active Comparator: Delayed Physical Therapy (PT)
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
Physical therapy delivered greater than 3 months after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: 6 and 12 months after hospital discharge
Neck Disability Index, 0-100 with higher scores indicating increased disability
6 and 12 months after hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Utilization
Time Frame: 6 and 12 months after hospital discharge
MMEs
6 and 12 months after hospital discharge
Return to work
Time Frame: 6 and 12 months after hospital discharge
Work Productivity and Activity Impairment Questionnaire
6 and 12 months after hospital discharge
Pain Intensity
Time Frame: 6 and 12 months after hospital discharge
Numeric Rating Scale, 0-10 with higher scores indicating increased pain intensity
6 and 12 months after hospital discharge
Pain Interference
Time Frame: 6 and 12 months after hospital discharge
PROMIS, 0-100 with higher scores indicating increased pain interference
6 and 12 months after hospital discharge
Physical Function
Time Frame: 6 and 12 months after hospital discharge
PROMIS, 0-100 with higher scores indicating better physical function
6 and 12 months after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Kristin Archer, PhD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

December 28, 2023

First Submitted That Met QC Criteria

January 1, 2024

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 231031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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