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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06202443
• Other study ID #: 231031
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: July 31, 2027

Study information

• Verified date: February 2024
• Source: Vanderbilt University Medical Center
• Contact: Amanda Priest
• Phone: 615-421-8336
• Email: amanda.priest[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: July 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spine Degeneration

Intervention

Other:
• Early PT
Physical therapy delivered within the first three months after surgery.
• Delayed PT
Physical therapy delivered greater than 3 months after surgery.

Locations

Country	Name	City	State
United States	Booke Army Medical Center	Fort Sam Houston	Texas
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability	Neck Disability Index, 0-100 with higher scores indicating increased disability	6 and 12 months after hospital discharge
Secondary	Pain Intensity	Numeric Rating Scale, 0-10 with higher scores indicating increased pain intensity	6 and 12 months after hospital discharge
Secondary	Pain Interference	PROMIS, 0-100 with higher scores indicating increased pain interference	6 and 12 months after hospital discharge
Secondary	Physical Function	PROMIS, 0-100 with higher scores indicating better physical function	6 and 12 months after hospital discharge
Secondary	Opioid Utilization	MMEs	6 and 12 months after hospital discharge
Secondary	Return to work	Work Productivity and Activity Impairment Questionnaire	6 and 12 months after hospital discharge