Back surgery pain mystery: study hunts for clues
NCT ID NCT03444168
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 158 adults to find out if certain traits or risk factors can predict who will develop chronic pain after lower back surgery. Researchers measured pain severity, disability, and other health factors using questionnaires. The goal was to better understand why some people continue to have pain after surgery, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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158 people
The number who actually took part.
- Started
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Jun 2018
- Finished
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Apr 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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22 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
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Other studies related to the condition(s) this trial covers.
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