Clinical trial NCT03444168: Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome
Official title: Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: lumbar spine surgery
lumbar failed back surgery syndrome
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2018-02-23
Enrollment: 158
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited directly by the Candidate and by referral from specialist physicians at the KUMC Marc A. Asher, MD, Comprehensive Spine and Pain Management Center.

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 surgery.


Eligibility criteria: 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)

Primary outcomes:
measure: Clinical pain severity
timeFrame: Change from Baseline to Month 6
Secondary outcomes:
measure: PROMIS (Patient-Reported Outcomes Measurement Information System)
timeFrame: Change from Baseline to Month 6
measure: Oswestry Disability Index
timeFrame: Change from Baseline to Month 6
measure: 2011 Fibromyalgia Survey
timeFrame: Change from Baseline to Month 6
Other outcomes:
measure: Magnetic Resonance Imaging - Brain Regions and Pain Processing
timeFrame: Baseline
measure: Quantitative Sensory Testing (QST) - Pressure pain sensitivity by Algometry
timeFrame: Baseline
measure: Quantitative Sensory Testing (QST) - Pressure pain sensitivity by Multimodal Automated Sensory Testing
timeFrame: Baseline
measure: Quantitative Sensory Testing (QST) - Cuff Algometry
timeFrame: Baseline
measure: Quantitative Sensory Testing (QST) - Conditioned Pain Modulation (CPM)
timeFrame: Change from Post-stimulus test at Baseline visit to Pre-stimulus test at Baseline visit
measure: Wind Up Ratio (WUR)
timeFrame: Baseline
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Andrea Chadwick, MD
role: PRINCIPAL_INVESTIGATOR
References: