Cervical Spine Degeneration, ACDF Surgery
Conditions
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.
Interventions
OTHEREarly PT
Physical therapy delivered within the first three months after surgery.
OTHERDelayed PT
Physical therapy delivered greater than 3 months after surgery.
Sponsors
Vanderbilt University Medical Center
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability | 6 and 12 months after hospital discharge | Neck Disability Index, 0-100 with higher scores indicating increased disability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 6 and 12 months after hospital discharge | Numeric Rating Scale, 0-10 with higher scores indicating increased pain intensity |
| Pain Interference | 6 and 12 months after hospital discharge | PROMIS, 0-100 with higher scores indicating increased pain interference |
| Physical Function | 6 and 12 months after hospital discharge | PROMIS, 0-100 with higher scores indicating better physical function |
| Opioid Utilization | 6 and 12 months after hospital discharge | MMEs |
| Return to work | 6 and 12 months after hospital discharge | Work Productivity and Activity Impairment Questionnaire |
Countries
United States
Contacts
CONTACTAmanda Priest
PRINCIPAL_INVESTIGATORKristin Archer, PhD
Vanderbilt University Medical Center
Outcome results
None listed