Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pain Severity - 50% Reduction Responders vs Nonresponders	Measured by the Brief Pain Inventory (BPI). The BPI scores are a numerical rating scale and range from 0 to 10. A score of 0 is equal to no pain and a score of 10 is equal to pain as bad as you can imagine.	Change from Baseline to Month 6
Fibromylagia-ness (FMness)	2011 Fibromyalgia Survey score is calculated by combining the widespread pain index (WPI) and the Symptom Severity Scale (SSI) to derive a score from 0-31. Scores greater than or equal to 13 indicate a diagnosis of Fibromyalgia. Higher scores indicate the degree of central sensitization present in a given individual.	Baseline
PROMIS T-score - Fatigue, Physical Function, Sleep-Related Impairment	PROMIS measures to be included are Depression, Anxiety, Physical Functioning, Fatigue, Sleep Impairment, Emotional Support, and Social Participation. Each questionnaire usually has 4-16 response options ranging in value from one to five. The total raw score for a short form with all questions answered is the sum of the values of the response to each question. The total range of potential raw scores depends on the number of questions being asked, for example, a 6 item form would have a range from is 6 to 30. After the raw score is calculated, a T-score metric is used to convert the raw score to a T-score. On the T-score metric, a score of 50 is the mean of a relevant reference population and 10 is the standard deviation of that mean. For PROMIS measures, higher scores equals "more of the concept being measured", this could be a desirable or undesirable outcome, depending on the concept being measured.	Baseline
PROMIS T-score - Anxiety, Depression, Emotional Support, Pain Interference, Satisfaction With Social Roles	PROMIS measures to be included are Depression, Anxiety, Physical Functioning, Fatigue, Sleep Impairment, Emotional Support, and Social Participation. Each questionnaire usually has 4-16 response options ranging in value from one to five. The total raw score for a short form with all questions answered is the sum of the values of the response to each question. The total range of potential raw scores depends on the number of questions being asked, for example, a 6 item form would have a range from is 6 to 30. After the raw score is calculated, a T-score metric is used to convert the raw score to a T-score. On the T-score metric, a score of 50 is the mean of a relevant reference population and 10 is the standard deviation of that mean. For PROMIS measures, higher scores equals "more of the concept being measured", this could be a desirable or undesirable outcome, depending on the concept being measured.	Baseline
Oswestry Disability Index	The Oswestry Disability Index will be used to assess low back pain. There are 10 sections on the index. Each section has a possible score of 5. The total possible range of scores is 0 to 50. A score of 0 indicates no pain. A score of 50 indicates the person is bed-bound or exaggerating their symptoms.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coping Strategies Questionnaire - CAT	A 6-item catastrophizing scale that measures ways to cope or deal with pain. Each item is scored on a scale of 0-6. Scores can range from 0-36, with the higher the score the higher the rate of catastrophizing.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative Sensory Testing (QST) - Conditioned Pain Modulation (CPM)	Conditioned Pain Modulation as measured at the thumbnail using the MAST. It yields a numerical pain rating difference on a 0-100 numerical scale that can either be positive or negative called CPM magnitude. CPM magnitude will be calculated as the difference (post-pre) in the mean of the three pain ratings given to the test stimulus prior to the conditioning stimuli and the three pain ratings of the test stimulus given during the conditioning stimuli. A reduction in test stimulus rating by conditioning stimulation implies functional (inhibitory) CPM, and the degree of reduction expresses the efficiency of CPM.	Change from Post-stimulus test at Baseline visit to Pre-stimulus test at Baseline visit
Quantitative Sensory Testing (QST) - Pressure Pain Sensitivity by Algometry - Trapezius	Pressure pain sensitivity is measured by Algometry (measured at the trapezius and lumbar spine). It yields a pressure pain threshold value measured in kPA. Tests were performed at the Left and Right trapezius in triplicate at each site and the average is calculated and used for analysis.	Baseline
Quantitative Sensory Testing (QST) - Pressure Pain Sensitivity by Algometry - Lower Back	Pressure pain sensitivity is measured by Algometry (measured at the trapezius and lumbar spine). It yields a pressure pain threshold value measured in kPA.Tests were performed at the Left and Right lumbar spine in triplicate at each site and the average is calculated and used for analysis.	Baseline
Quantitative Sensory Testing (QST) - Pressure Pain Sensitivity by Multimodal Automated Sensory Testing	Pressure pain sensitivity is measured by the Multimodal Automated Sensory Testing (MAST) System (measured at the thumbnail). It yields a pressure pain threshold value measured in kg/cm2. Thumb Pain30, Pain40, and Pain50 are the pressure intensities that provoke a pain rating of 30/100, 40/100, and 50/100, respectively. Thumb Pain Tolerance is the pressure intensity that provokes a response greater than or equal to 80/100.	Baseline

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Andrea Chadwick, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2018
• Primary Completion (Actual): April 20, 2023
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: lumbar spine surgery; lumbar failed back surgery syndrome
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: STUDY00140263; 1K23GM123320-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No