Cervical Spine Degenerative Disease, Spinal Fusion
Conditions
Brief summary
The overall objective of this two-group randomized controlled trial is to gather preliminary evidence on the efficacy and safety of early postoperative exercise for improving disability, pain, and general physical health in patients after anterior cervical discectomy and fusion (ACDF) surgery. Our central hypothesis is that an early home exercise program (HEP) performed within the first six weeks after surgery will decrease disability and pain and improve general health, through increases in physical activity and self-efficacy and reductions in fear of movement. The results of our randomized trial will advance research on postoperative management for patients with cervical spine surgery and provide evidence in line with a value-based healthcare approach for optimizing outcomes.
Interventions
BEHAVIORALEarly Home Exercise Program
The early home exercise program is a 6-week program of home exercises with weekly phone calls to monitor progression and compliance.
OTHERUsual Care
Usual care involves standard postoperative management under the direction of the treating surgeon.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Surgical treatment of a cervical degenerative condition (cervical stenosis, spondylosis, degenerative spondylolisthesis, disc herniation) using anterior cervical discectomy and fusion procedure; 2. English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and 3. Age older than 21 years (younger individuals do not typically have a cervical degenerative condition)
Exclusion criteria
1. Patients having surgery secondary to trauma, fracture, tumor, infection, or spinal deformity; 2. Patients undergoing cervical corpectomy; 3. Diagnosis or presence of severe psychiatric disorder such as schizophrenia or other psychotic disorder, including but not limited to Brief Psychotic disorder and Delusional disorder; 4. Documented history of alcohol and/or drug abuse; 5. Patients having surgery under a workman's compensation claim; and 6. Unable to provide a stable telephone or physical address
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index (NDI) | Up to 12 months after surgery | The NDI measures disease-specific disability for cervical spine patients. |
| Numeric Rating Scale (NRS) | Up to 12 months after surgery | The NRS measures levels of neck and arm pain intensity. |
| 12-Item Short Form Health Survey (SF-12) | Up to 12 months after surgery | The SF-12 is a measure of general physical and mental health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Movement Accelerometry | Up to 12 months after surgery | Movement accelerometry measures general physical activity level. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fusion rate | 6 months after surgery | Fusion rate will be measured using dynamic flexion-extension radiograph. |
Countries
United States
Outcome results
None listed