Early Postoperative Home Exercise Program After Cervical Spine Surgery

Not Applicable

Completed

• Conditions: Spinal Fusion; Cervical Spine Degenerative Disease
• Interventions: Other: Usual Care; Behavioral: Early Home Exercise Program

• Registration Number: NCT02720172
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-25
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Usual postoperative care.
Early Home Exercise Program	Early Home Exercise Program	The early home exercise program is an exercise-based self-management program for patients immediately after cervical spine surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Movement Accelerometry	Up to 12 months after surgery	Movement accelerometry measures general physical activity level.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States