Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome (NCT03444168) | Clinical Trial Compass
CompletedNot Applicable
Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome
United States158 participantsStarted 2018-06-29
Plain-language summary
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.
Who can participate
Age range22 Years ā 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 canā¦
What they're measuring
1
Clinical Pain Severity - 50% Reduction Responders vs Nonresponders