Status:
COMPLETED
Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Chronic Pain
Eligibility:
All Genders
22-70 years
Brief 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 surger...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
June 29 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT03444168
Start Date
June 29 2018
End Date
April 20 2023
Last Update
February 9 2024
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160