← Back to Search

Early Physical Therapy (PT) for Cervical Spondylosis

N/A

Recruiting

Led By Kristin Archer, PhD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Surgical treatment of a cervical degenerative condition using a 1- or 2-level ACDF procedure

Age 18-75 years of age (individuals older than 75 are more likely to experience respiratory and nervous system complications and death following ACDF)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months after hospital discharge

Awards & highlights

Study Summary

This trial wants to see if starting physical therapy (PT) right after surgery for ACDF (an operation on the neck) is better than waiting to start PT later. They want to know if starting

Who is the study for?

This trial is for individuals who have undergone ACDF surgery to address cervical fusion or cervical spondylosis. The study will include those eligible and willing to start physical therapy (PT) either early or later after their operation.Check my eligibility

What is being tested?

The study is testing the effectiveness of starting physical therapy soon after ACDF surgery versus waiting for a delayed PT start. Participants are randomly assigned to one of these two approaches, and their recovery outcomes are compared.See study design

What are the potential side effects?

Since this trial involves postoperative physical therapy, potential side effects may include muscle soreness, fatigue, discomfort at the surgical site during exercises, and risk of strain with improper exercise technique.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had surgery for neck pain using a 1- or 2-level ACDF procedure.

Select...

I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months after hospital discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months after hospital discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months after hospital discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disability

Secondary outcome measures

Opioid Utilization

Pain Intensity

Pain Interference

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Early Physical Therapy (PT)Experimental Treatment1 Intervention

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

Group II: Delayed Physical Therapy (PT)Active Control1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

865 Previous Clinical Trials

327,623 Total Patients Enrolled

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,117 Total Patients Enrolled

Kristin Archer, PhDPrincipal InvestigatorVanderbilt University Medical Center

2 Previous Clinical Trials

177 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the inclusion criteria for this research study open to individuals below the age of 55?

"To be eligible for this research study, participants must meet the age requirements of being at least 18 years old and not exceeding 75 years old."

Answered by AI

Which specific criteria determine the eligibility of individuals to participate in this study?

"In order to be eligible for enrollment in this clinical trial, individuals must have a diagnosis of cervical spondylosis and fall within the age range of 18 to 75. Approximately 76 participants are being sought for recruitment into the study."

Answered by AI

Are patients currently being recruited for participation in this medical trial?

"As per clinicaltrials.gov, this particular trial is not actively recruiting participants at the moment. The trial was initially posted on January 2nd, 2024 and last modified on January 1st, 2024. However, it's worth noting that there are currently one other ongoing trials seeking eligible candidates for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Surgical Outcomes With Early PT After ACDF

Kristin Archer 2024. "Improving Surgical Outcomes With Early PT After ACDF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06202443.

All > Pflugerville Tx > Nashville