Chronic Pain
Conditions
Keywords
lumbar spine surgery, lumbar failed back surgery syndrome
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.
Interventions
None listed
Sponsors
University of Kansas Medical Center
National Institute of General Medical Sciences (NIGMS)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pain Severity - 50% Reduction Responders vs Nonresponders | 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) | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Coping Strategies Questionnaire - CAT | Baseline | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrea Chadwick, MD
University of Kansas Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 137 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race American Indian, Alaskan | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants |
| Race/Ethnicity, Customized Race Black, African American | 8 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Other, Unknown | 3 Participants |
| Race/Ethnicity, Customized Race White | 37 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 55 | 0 / 40 | 0 / 49 |
| other Total, other adverse events | 0 / 55 | 0 / 40 | 0 / 49 |
| serious Total, serious adverse events | 1 / 55 | 0 / 40 | 0 / 49 |
Outcome results
None listed