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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02720172
Other study ID # 150912
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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