Early Postoperative Home Exercise Program After Cervical Spine Surgery

Spinal Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720172
• Other study ID #: 150912
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: July 2018

Study information

• Verified date: February 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spine Degenerative Disease
• Spinal Fusion

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fusion rate	Fusion rate will be measured using dynamic flexion-extension radiograph.	6 months after surgery
Primary	Neck Disability Index (NDI)	The NDI measures disease-specific disability for cervical spine patients.	Up to 12 months after surgery
Primary	Numeric Rating Scale (NRS)	The NRS measures levels of neck and arm pain intensity.	Up to 12 months after surgery
Primary	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	Movement Accelerometry	Movement accelerometry measures general physical activity level.	Up to 12 months after surgery