Early Postoperative Home Exercise Program After Cervical Spine Surgery

NCT ID: NCT02720172

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-07-31

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.

Conditions

Spinal Fusion; Cervical Spine Degenerative Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early Home Exercise Program

The early home exercise program is an exercise-based self-management program for patients immediately after cervical spine surgery.

Group Type: EXPERIMENTAL

Early Home Exercise Program

Intervention Type: BEHAVIORAL

The early home exercise program is a 6-week program of home exercises with weekly phone calls to monitor progression and compliance.

Usual Care

Usual postoperative care.

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Usual care involves standard postoperative management under the direction of the treating surgeon.

Interventions

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.

Intervention Type: BEHAVIORAL

Usual Care

Usual care involves standard postoperative management under the direction of the treating surgeon.

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kristin Archer

Associate Professor and Vice Chair of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin R Archer, PhD, DPT

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Rogelio A Coronado, PT, PhD

Role: STUDY_DIRECTOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

150912

Identifier Type: -

Identifier Source: org_study_id