Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Clinical Pain Severity - 50% Reduction Responders vs Nonresponders
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
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.
Outcomes
Primary Outcomes
Clinical Pain Severity - 50% Reduction Responders vs Nonresponders
Time Frame: Change from Baseline to Month 6
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.
Fibromylagia-ness (FMness)
Time Frame: Baseline
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.
PROMIS T-score - Fatigue, Physical Function, Sleep-Related Impairment
Time Frame: Baseline
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.
PROMIS T-score - Anxiety, Depression, Emotional Support, Pain Interference, Satisfaction With Social Roles
Time Frame: Baseline
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.
Oswestry Disability Index
Time Frame: Baseline
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.
Secondary Outcomes
- Coping Strategies Questionnaire - CAT(Baseline)