Improving Surgical Outcomes With Early PT After ACDF

Cervical Spine Degeneration Clinical Trial

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

Status Recruiting

Clinical Trial 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 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cervical Spine Degeneration

• NCT number: NCT06202443
• Study type: Interventional
• Source: Vanderbilt University Medical Center
• Contact: Amanda Priest
• Phone: 615-421-8336
• Email: amanda.priest@vumc.org
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Completion date: July 31, 2027