A Randomized Trial of an Early Postoperative Home Exercise Program Versus Usual Care After Anterior Cervical Discectomy and Fusion Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Fusion
- Sponsor
- Vanderbilt University Medical Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Neck Disability Index (NDI)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Kristin Archer
Associate Professor and Vice Chair of Research
Vanderbilt University Medical Center
Eligibility Criteria
Inclusion Criteria
- •Surgical treatment of a cervical degenerative condition (cervical stenosis, spondylosis, degenerative spondylolisthesis, disc herniation) using anterior cervical discectomy and fusion procedure;
- •English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and
- •Age older than 21 years (younger individuals do not typically have a cervical degenerative condition)
Exclusion Criteria
- •Patients having surgery secondary to trauma, fracture, tumor, infection, or spinal deformity;
- •Patients undergoing cervical corpectomy;
- •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;
- •Documented history of alcohol and/or drug abuse;
- •Patients having surgery under a workman's compensation claim; and
- •Unable to provide a stable telephone or physical address
Outcomes
Primary Outcomes
Neck Disability Index (NDI)
Time Frame: Up to 12 months after surgery
The NDI measures disease-specific disability for cervical spine patients.
Numeric Rating Scale (NRS)
Time Frame: Up to 12 months after surgery
The NRS measures levels of neck and arm pain intensity.
12-Item Short Form Health Survey (SF-12)
Time Frame: Up to 12 months after surgery
The SF-12 is a measure of general physical and mental health.
Secondary Outcomes
- Movement Accelerometry(Up to 12 months after surgery)