Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome

University of Kansas

Status: Completed

Conditions: Chronic Pain

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03444168

STUDY00140263

1K23GM123320-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 22 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

158 participants in 3 patient groups

Candidate for Lumbar Spine Surgery

Description:

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

Description:

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

Description:

Participants are a healthy volunteer wishing to participate in a research study.