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Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome | Clinical Trials | Clareo Health

COMPLETED

Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome

NCT03444168•University of Kansas Medical Center

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.

Eligibility

Age

22 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Ability to read and speak English to allow for written informed consent, phenotyping, and patient-reported outcomes measures
•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.
•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)
•No major diseases or diagnoses influencing pain or function

Exclusion Criteria

•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
+7 more criteria

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Key Dates

Start Date

June 29, 2018

Primary Completion Date

April 20, 2023

Completion Date

April 20, 2023

Last Updated

March 13, 2026

Enrollment

158

ACTUAL participants

Conditions

Chronic Pain

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome

Inclusion Criteria

Exclusion Criteria

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