Clinical trial NCT02720172: Early Postoperative Home Exercise Program After Cervical Spine Surgery
Official title: A Randomized Trial of an Early Postoperative Home Exercise Program Versus Usual Care After Anterior Cervical Discectomy and Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Fusion
Cervical Spine Degenerative Disease
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: Up to 12 months after surgery
measure: Numeric Rating Scale (NRS)
timeFrame: Up to 12 months after surgery
measure: 12-Item Short Form Health Survey (SF-12)
timeFrame: Up to 12 months after surgery
Secondary outcomes:
measure: Movement Accelerometry
timeFrame: Up to 12 months after surgery
Other outcomes:
measure: Fusion rate
timeFrame: 6 months after surgery
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Kristin R Archer, PhD, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Rogelio A Coronado, PT, PhD
role: STUDY_DIRECTOR
References: