NCT02720172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

2.3 years

First QC Date

March 21, 2016

Last Update Submit

February 11, 2019

Conditions

Spinal FusionCervical Spine Degenerative Disease

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Movement Accelerometry

    Up to 12 months after surgery

Other Outcomes (1)

  • Fusion rate

    6 months after surgery

Study Arms (2)

Early Home Exercise Program

EXPERIMENTAL

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

Behavioral: Early Home Exercise Program

Usual Care

OTHER

Usual postoperative care.

Other: Usual Care

Interventions

Early Home Exercise ProgramBEHAVIORAL

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

Early Home Exercise Program
Usual CareOTHER

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

Usual Care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Study Officials

  • Kristin R Archer, PhD, DPT

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

  • Rogelio A Coronado, PT, PhD

    Vanderbilt University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Vice Chair of Research

Study Record Dates

First Submitted

March 21, 2016

First Posted

March 25, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

February 12, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)