Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome



Status:Recruiting
Conditions:Chronic Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:22 - Any
Updated:3/8/2019
Start Date:June 29, 2018
End Date:March 31, 2021
Contact:Andrea Nicol, MD
Email:anicol@kumc.edu
Phone:(913) 588-9900

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The purpose of this study is to learn whether or not certain risk factors and patient
characteristics are linked with and possibly can predict the development of chronic pain
after lumbar spine surgery.


Inclusion Criteria For All Participants:

- Ability to read and speak English to allow for written informed consent, phenotyping,
and patient-reported outcomes measures

Exclusion Criteria For All Participants:

- Individuals receiving or applying for compensation or disability and other aspects
associated with potential secondary gain

- Inability to provide written informed consent

- Severe physical impairment

- Co-morbid medical conditions that may significantly impair physical functional status

- Illicit drug or unreported opioid use

- Medical or psychiatric conditions that in the judgment of study personnel would
preclude participation in this study

- Pregnant or nursing

- Liver failure

- Self-reported liver cirrhosis

- Self-reported hepatitis

- Severe Cardiovascular disease

Inclusion Criteria for Candidates for Lumbar Spine Surgery:

- Deemed to be a candidate for primary lumbar spine surgery including but not limited
to: lumbar laminectomy, discectomy, and fusion/instrumentation

- Diagnostic clinical and radiographic findings including but not limited to: lumbar
degenerative disc disease, lumbar disc protrusion, herniation, or extrusion, lumbar
spondylosis, lumbar spinal stenosis, lumbar spondylolisthesis or spondylolysis

- Willingness to participate in longitudinal follow-up or 6-months after their surgery.

Exclusion Criteria for Candidates for Lumbar Spine Surgery:

- History of previous lumbar spine surgery

- Indication for lumbar spine surgery is due to spinal cancer-related diagnosis

- Need for urgent or emergent lumbar spine surgery

Inclusion Criteria for Candidates with Lumbar Failed Back Surgery Syndrome:

- Chronic low back pain (+/- leg pain) for >= to 6 months duration after lumbar spine
surgery (with or without instrumented fusion)

- Low back pain severity is moderate to severe (Numerical Rating Scale [NRS] Score >=4)

Exclusion Criteria for Candidates with Lumbar Failed Back Surgery Syndrome:

- Have a structural spinal lesion that would make them a current candidate for a
revision lumbar spine surgery

Inclusion Criteria for Healthy Volunteers:

- No major diseases or diagnoses influencing pain or function

Exclusion Criteria for Healthy Volunteers:

- No chronic pain condition

- Score 3 or greater on the 2011 FM Survey Criteria (i.e. individuals with very mild
fatigue or sleep problems will be allowed to participate as this is extremely common
in the general population)
We found this trial at
1
site
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Phone: 913-588-3479
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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