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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23GM123320-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria For All Participants:
Exclusion Criteria For All Participants:
Inclusion Criteria for Candidates for Lumbar Spine Surgery:
Exclusion Criteria for Candidates for Lumbar Spine Surgery:
Inclusion Criteria for Candidates with Lumbar Failed Back Surgery Syndrome:
Exclusion Criteria for Candidates with Lumbar Failed Back Surgery Syndrome:
Inclusion Criteria for Healthy Volunteers:
Exclusion Criteria for Healthy Volunteers:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Chadwick, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Healthy Volunteer | Participants are a healthy volunteer wishing to participate in a research study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Lumbar Failed Back Surgery Syndrome |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Lumbar Spine Surgery Candidates (LSS) were asked BPI prior to surgery (baseline) and 6 months post surgery. Based on this response, participants were split in to two groups, responders vs non-responders. Responders were defined as patients who reported a >50% reduction in pain on the BPI. Only participants in the LSS group participated in longitudinal follow-up. | Posted | Median | Inter-Quartile Range | percentage of change | Change from Baseline to Month 6 |
|
AEs were assessed via pt-report or via EMR notification for the duration of the study, approximately 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lumbar Spine Surgery Candidates | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | SAE unrelated to study procedures, occurred during follow-up period. |
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Trial was conducted during the start of COVID-19, which drastically impacted surgery number and selection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrea Chadwick | The University of Kansas Medical Center | 913-588-3479 | facelab@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2020 | Nov 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| 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 |
| 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 |
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. |
| BG002 | Healthy Volunteer | Participants are a healthy volunteer with no chronic pain who are wishing to participate in a research study. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Lumbar Spine Surgery - Non-Responders | Participants who received lumbar spine surgery to treat chronic low back and/or leg pain and have reported a less than 50% reduction in pain BPI between baseline and 6 months |
|
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| Primary | 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. | Lumbar Spine Surgery Candidates were asked BPI prior to surgery (baseline) and 6 months post surgery. Based on this response, participants were split in to two groups, responders vs non-responders. Responders were defined as patients who reported a >50% reduction in pain on the BPI. health surgery syndrome. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | 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. | Lumbar Spine Surgery Candidates were asked BPI prior to surgery (baseline) and 6 months post surgery. Based on this response, participants were split in to two groups, responders vs non-responders. Responders were defined as patients who reported a >50% reduction in pain on the BPI. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline |
|
|
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| Primary | 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. | 141 participants were analyzed at baseline. 3 participants did not have complete baseline data for these instruments and thus were not included in analysis. Lumbar Spine Surgery Pts were asked BPI prior to surgery (baseline) and 6 months post surgery. Based on this response, participants were split in to two groups. Responders were defined as patients who reported a >50% reduction in pain on the BPI. Results were compared to the healthy controls and failed back surgery syndrome participants. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline |
|
|
|
| Primary | 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. | 141 pts were analyzed at baseline. Lumbar Spine Surgery Candidates were asked BPI prior to surgery (baseline) and 6 months post surgery. Based on this response, participants were split in to two groups, responders vs non-responders. Responders were defined as patients who reported a >50% reduction in pain on the BPI. Results were compared to the healthy controls and failed back surgery syndrome participants. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline |
|
|
|
| Secondary | 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. | Lumbar Spine Surgery Candidates were asked BPI prior to surgery (baseline) and 6 months post surgery. Based on this response, participants were split in to two groups, responders vs non-responders. Responders were defined as patients who reported a >50% reduction in pain on the BPI. Results were compared to the healthy controls and failed back surgery syndrome participants. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
|
|
|
| Other Pre-specified | 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. | These numbers represent the subset of pts who participated in QST. Lumbar Spine Surgery Candidates were asked BPI prior to surgery (baseline) and 6 months post surgery. Based on this response, participants were split in to two groups, responders vs non-responders. Responders were defined as patients who reported a >50% reduction in pain on the BPI. Results were compared to the healthy controls and failed back surgery syndrome participants. | Posted | Median | Inter-Quartile Range | kPA | Baseline |
|
|
|
| Other Pre-specified | 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. | A subset of participants completed QST measure at baseline. Lumbar Spine Surgery Candidates were asked BPI prior to surgery (baseline) and 6 months post surgery. Based on this response, participants were split in to two groups, responders vs non-responders. Responders were defined as patients who reported a >50% reduction in pain on the BPI. Results were compared to the healthy controls and failed back surgery syndrome participants. | Posted | Median | Inter-Quartile Range | kPA | Baseline |
|
|
|
| Other Pre-specified | 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. | A subset of participants completed QST measure at baseline. Lumbar Spine Surgery Candidates were asked BPI prior to surgery (baseline) and 6 months post surgery. Based on this response, participants were split in to two groups, responders vs non-responders. Responders were defined as patients who reported a >50% reduction in pain on the BPI. Results were compared to the healthy controls and failed back surgery syndrome participants. | Posted | Median | Inter-Quartile Range | kg/cm^2 | Baseline |
|
|
|
| Other Pre-specified | 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. | A subset of participants completed QST measure at baseline. Lumbar Spine Surgery Candidates were asked BPI prior to surgery (baseline) and 6 months post surgery. Based on this response, participants were split in to two groups, responders vs non-responders. Responders were defined as patients who reported a >50% reduction in pain on the BPI. Results were compared to the healthy controls and failed back surgery syndrome participants. | Posted | Median | Inter-Quartile Range | units on a scale | Change from Post-stimulus test at Baseline visit to Pre-stimulus test at Baseline visit |
|
|
|
| 1 |
| 55 |
| 1 |
| 55 |
| 0 |
| 55 |
| EG001 | Healthy Control Participants | Patients with no chronic pain who were not undergoing a lumbar spine surgery. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG002 | Failed Back Surgery Syndrome Participants | Participants who had a lumbar spine surgery procedure and still reported moderate to severe lower back pain. | 0 | 49 | 0 | 49 | 0 | 49 |
|
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D001416 | Back Pain |
| FM positive |
|
| Physical Function v2.0 8b |
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| Sleep-Related Impairment v1.0 8a |
|
| Depression v1.0 8a |
|
| Emotional Support v2.0 4a |
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| Pain Interference v2.0 8b |
|
| Satisfaction with Social Roles v1.0 4a |
|
| Right Trapezius |
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| Right Back |
|
| Thumb Pain40 |
|
| Thumb Pain50 |
|
| Thumb Pain Tolerance |
|