Function After Anterior Cervical Discectomy and Fusion Surgery: Timing of Physical Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Early PT
Other interventionPhysical therapy delivered within the first three months after surgery.
Delayed PT
Other interventionPhysical therapy delivered greater than 3 months after surgery.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Early Physical Therapy (PT)Experimental treatment 1 intervention
Group B: Delayed Physical Therapy (PT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Disability
Neck Disability Index, 0-100 with higher scores indicating increased disability
Time frame
6 and 12 months after hospital dischargeSecondary outcomes
1
Pain Intensity
Numeric Rating Scale, 0-10 with higher scores indicating increased pain intensity
Time frame
6 and 12 months after hospital discharge2
Pain Interference
PROMIS, 0-100 with higher scores indicating increased pain interference
Time frame
6 and 12 months after hospital discharge3
Physical Function
PROMIS, 0-100 with higher scores indicating better physical function
Time frame
6 and 12 months after hospital discharge4
Opioid Utilization
MMEs
Time frame
6 and 12 months after hospital dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vanderbilt University Medical Center
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov