Spinal FusionNCT02720172

Early Postoperative Home Exercise Program After Cervical Spine Surgery

A study testing Early Home Exercise Program in people with Spinal Fusion and Cervical Spine Degenerative Disease, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Spinal Fusion, Cervical Spine Degenerative Disease
What is being tested?: Early Home Exercise Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Mar 2016to Jul 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: A Randomized Trial of an Early Postoperative Home Exercise Program Versus Usual Care After Anterior Cervical Discectomy and Fusion 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.

Conditions: Spinal Fusion, Cervical Spine Degenerative Disease
Being tested: Early Home Exercise Program, Usual Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Early Home Exercise ProgramBehavioural
The early home exercise program is a 6-week program of home exercises with weekly phone calls to monitor progression and compliance.
Usual CareOther
Usual care involves standard postoperative management under the direction of the treating surgeon.

Study groups in NCT02720172
Study group	Role	What they receive
Early Home Exercise Program	Experimental	The early home exercise program is an exercise-based self-management program for patients immediately after cervical spine surgery. Receives: Behavioral: Early Home Exercise Program
Usual Care	Other	Usual postoperative care. Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Neck Disability Index (NDI)
The NDI measures disease-specific disability for cervical spine patients.
Measured: Up to 12 months after surgery
Numeric Rating Scale (NRS)
The NRS measures levels of neck and arm pain intensity.
Measured: 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.
Measured: Up to 12 months after surgery

Secondary outcomes (1)

Movement Accelerometry
Movement accelerometry measures general physical activity level.
Measured: Up to 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Jul 2018

First posted25 Mar 2016 (estimated)
Study startMar 2016
Primary completionJul 2018
Study completionJul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Spinal FusionStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02720172
Sponsor's protocol ID: 150912
Status last verified: Feb 2019
First submitted: 21 Mar 2016
Last updated: 12 Feb 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy

All Spinal Fusion trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial of an Early Postoperative Home Exercise Program Versus Usual Care After Anterior Cervical Discectomy and Fusion Surgery
ClinicalTrials.gov ID: NCT02720172
Acronym / sponsor ID: 150912
Conditions: Spinal Fusion, Cervical Spine Degenerative Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Study start: Mar 2016 (actual)
Primary completion: Jul 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 25 Mar 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Early Home Exercise Program	Experimental	Behavioral: Early Home Exercise ProgramThe early home exercise program is an exercise-based self-management program for patients immediately after cervical spine surgery.
Usual Care	Other	Other: Usual CareUsual postoperative care.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Early Home Exercise ProgramThe early home exercise program is a 6-week program of home exercises with weekly phone calls to monitor progression and compliance.	Behavioural	Early Home Exercise Program
Usual CareUsual care involves standard postoperative management under the direction of the treating surgeon.	Other	Usual Care

Primary outcome

Neck Disability Index (NDI)
Time frame: Up to 12 months after surgery
The NDI measures disease-specific disability for cervical spine patients.
Numeric Rating Scale (NRS)
Time frame: Up to 12 months after surgery
The NRS measures levels of neck and arm pain intensity.
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.

1 secondary outcome

Movement Accelerometry
Time frame: Up to 12 months after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
Individual participant dataSharing planned: No

Related trials for Spinal Fusion

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kristin R Archer, PhD, DPT principal investigator

Vanderbilt University Medical Center

Rogelio A Coronado, PT, PhD study director

Vanderbilt University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Early Home Exercise Program in people with Spinal Fusion and Cervical Spine Degenerative Disease, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck Disability Index (NDI) (time frame: Up to 12 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02720172.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.