Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome

NCT ID: NCT03444168

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 158 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-29
• Study Completion Date: 2023-04-20

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.

Conditions

Chronic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Healthy Volunteer

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

No interventions assigned to this group

Eligibility Criteria

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
• Severe Cardiovascular disease

• 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

• Have a structural spinal lesion that would make them a current candidate for a revision lumbar spine surgery

• 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)

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Chadwick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

1K23GM123320-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00140263

Identifier Type: -

Identifier Source: org_study_id