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Back surgery pain mystery: study hunts for clues

NCT ID NCT03444168

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

158 people

The number who actually took part.

Started

Jun 2018

Finished

Apr 2023

Lead sponsor

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

22 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Chronic Pain chronic pain syndrome Failed Back Surgery Syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.