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Completed

NCT Number: NCT02720172

Early Postoperative Home Exercise Program After Cervical Spine 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.

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Key information

Conditions

Spinal Fusion Cervical Spine Degenerative Disease

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Home Exercise Program

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

Other

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

Primary outcomes

  1. Neck Disability Index (NDI)

    Time frame: Up to 12 months after surgery

    The NDI measures disease-specific disability for cervical spine patients.

  2. Numeric Rating Scale (NRS)

    Time frame: Up to 12 months after surgery

    The NRS measures levels of neck and arm pain intensity.

  3. 12-Item Short Form Health Survey (SF-12)

    Time frame: Up to 12 months after surgery

    The SF-12 is a measure of general physical and mental health.

Secondary outcomes

  1. Movement Accelerometry

    Time frame: Up to 12 months after surgery

    Movement accelerometry measures general physical activity level.

Other outcomes

  1. Fusion rate

    Time frame: 6 months after surgery

    Fusion rate will be measured using dynamic flexion-extension radiograph.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 25, 2016
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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