Early Postoperative Home Exercise Program After Cervical Spine Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Fusion; Cervical Spine Degenerative Disease
• Intervention / Treatment: Behavioral: Early Home Exercise Program; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Home Exercise Program; The early home exercise program is an exercise-based self-management program for patients immediately after cervical spine surgery.	Behavioral: Early 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.
Other: Usual Care; Usual postoperative care.	Other: Usual Care; Usual care involves standard postoperative management under the direction of the treating surgeon.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion rate	Fusion rate will be measured using dynamic flexion-extension radiograph.	6 months after surgery

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Kristin R Archer, PhD, DPT, Vanderbilt University Medical Center; Study Director: Rogelio A Coronado, PT, PhD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 11, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 150912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO