N/A
N=158
Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT03444168 ↗Enrolled (actual)
158
Serious AEs
0.7%
Results posted
Mar 2026
Primary outcome: Primary: Clinical Pain Severity - 50% Reduction Responders vs Nonresponders — -83; 0 percentage of change
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Pain Severity - 50% Reduction Responders vs Nonresponders |
-83; 0 | — |
| PRIMARY Fibromylagia-ness (FMness) |
17; 27; 26; 40; 4; 4 | — |
| PRIMARY PROMIS T-score - Fatigue, Physical Function, Sleep-Related Impairment |
58.80; 56.40; 62.40; 42; 34.70; 35.30 | — |
| PRIMARY PROMIS T-score - Anxiety, Depression, Emotional Support, Pain Interference, Satisfaction With Social Roles |
50.3; 49.8; 51.00; 43.35; 54.5; 52.0 | — |
| PRIMARY Oswestry Disability Index |
42; 40; 44; 1 | — |
| SECONDARY Coping Strategies Questionnaire - CAT |
8; 2; 8; 0.50 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT03444168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.