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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
Physical therapy delivered within the first three months after surgery.
Physical therapy delivered greater than 3 months after surgery.
Tripler Army Medical Center
Honolulu, Hawaii, United States
RECRUITINGVanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGBooke Army Medical Center
Fort Sam Houston, Texas, United States
RECRUITINGMadigan Army Medical Center
Tacoma, Washington, United States
RECRUITINGDisability
Neck Disability Index, 0-100 with higher scores indicating increased disability
Time frame: 6 and 12 months after hospital discharge
Pain Intensity
Numeric Rating Scale, 0-10 with higher scores indicating increased pain intensity
Time frame: 6 and 12 months after hospital discharge
Pain Interference
PROMIS, 0-100 with higher scores indicating increased pain interference
Time frame: 6 and 12 months after hospital discharge
Physical Function
PROMIS, 0-100 with higher scores indicating better physical function
Time frame: 6 and 12 months after hospital discharge
Opioid Utilization
MMEs
Time frame: 6 and 12 months after hospital discharge
Return to work
Work Productivity and Activity Impairment Questionnaire
Time frame: 6 and 12 months after hospital discharge
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