Clinical trial NCT06202443: Improving Surgical Outcomes With Early PT After ACDF
Official title: Improving Surgical Outcomes With Early Physical Therapy After Anterior Cervical Discectomy and Fusion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Spine Degeneration
ACDF Surgery
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-01-11
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disability
timeFrame: 6 and 12 months after hospital discharge
Secondary outcomes:
measure: Pain Intensity
timeFrame: 6 and 12 months after hospital discharge
measure: Pain Interference
timeFrame: 6 and 12 months after hospital discharge
measure: Physical Function
timeFrame: 6 and 12 months after hospital discharge
measure: Opioid Utilization
timeFrame: 6 and 12 months after hospital discharge
measure: Return to work
timeFrame: 6 and 12 months after hospital discharge
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Sam Houston
country: United States
facility: Booke Army Medical Center
state: Texas
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Vanderbilt University Medical Center
name: Kristin Archer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.