Early Postoperative Home Exercise Program After Cervical Spine Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Trial of an Early Postoperative Home Exercise Program Versus Usual Care After Anterior Cervical Discectomy and Fusion Surgery

Conditions
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Spinal Fusion, Cervical Spine Degenerative Disease

Intervention / Treatment
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* Behavioral: Early Home Exercise Program
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Home Exercise Program<br>The early home exercise program is an exercise-based self-management program for patients immediately after cervical spine surgery. | Behavioral: Early Home Exercise Program<br>* The early home exercise program is a 6-week program of home exercises with weekly phone calls to monitor progression and compliance.<br>|
| Other: Usual Care<br>Usual postoperative care. | Other: Usual Care<br>* Usual care involves standard postoperative management under the direction of the treating surgeon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index (NDI) | The NDI measures disease-specific disability for cervical spine patients. | Up to 12 months after surgery | 
| Numeric Rating Scale (NRS) | The NRS measures levels of neck and arm pain intensity. | Up to 12 months after surgery | 
| 12-Item Short Form Health Survey (SF-12) | The SF-12 is a measure of general physical and mental health. | Up to 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Accelerometry | Movement accelerometry measures general physical activity level. | Up to 12 months after surgery |