Purpose

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.

Condition

Eligibility

Eligible Ages
Between 22 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Candidate for Lumbar Spine Surgery Participants have been designated to be a candidate for lumbar spine surgery to treat chronic low back and/or leg pain and you have agreed to proceed with the surgery.
Lumbar Failed Back Surgery Syndrome Participants have been diagnosed with having lumbar failed back surgery syndrome and have persistent and moderate-to-severe low back and/or leg pain for more than 6 months after a lumbar spine surgery.
Healthy Volunteer Participants are a healthy volunteer wishing to participate in a research study.

More Details

Status
Completed
Sponsor
University of Kansas Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.