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| ID | Type | Description | Link |
|---|---|---|---|
| R21AR068009 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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To identify patient characteristics associated with non-response after spine fusion surgery for the treatment of degenerative disc disease (DDD).
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| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index | Change in pain and function after spine fusion surgery was measured by the Oswestry Disability Index. Scores range from 0 to 100. The questionnaire has 10 questions about pain intensity, personal care, lifting ability, walking ability, sitting ability, standing ability, sleeping ability, sex ability, social life, and travelling. Each question is followed by 6 options which describe the amount of disability a patient may face in these situations and the patient marks the statement most applicable to them. Each question is scored on a scale (0-5) with the first option "0" indicating the least amount of disability and "5" indicating the most severe disability. Higher scores indicate worse outcomes, lower scores indicate better outcomes. | Baseline, 60 day, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Adults (18 and over) undergoing spine fusion surgery in Washington State.
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| Name | Affiliation | Role |
|---|---|---|
| Amy M Cizik, MPH, PhC | University of Washington | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98105 | United States | ||
| Proliance Surgeons |
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| Label | URL |
|---|---|
| Related Info | View source |
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If participants did not complete a baseline survey before their lumbar spine fusion surgery or were found to be ineligible they were excluded from the study before completing follow-up surveys.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spine Fusion Participants | Patients undergoing lumbar spine fusion surgery for any indication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Enrollment |
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| Post-Surgery Follow-up at 30-90 Days |
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| Post-Surgery Follow-up at 1-Year |
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| Data Cleaning |
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| ID | Title | Description |
|---|---|---|
| BG000 | Spine Fusion Participants | Patients undergoing lumbar spine fusion surgery for any indication. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Oswestry Disability Index | Change in pain and function after spine fusion surgery was measured by the Oswestry Disability Index. Scores range from 0 to 100. The questionnaire has 10 questions about pain intensity, personal care, lifting ability, walking ability, sitting ability, standing ability, sleeping ability, sex ability, social life, and travelling. Each question is followed by 6 options which describe the amount of disability a patient may face in these situations and the patient marks the statement most applicable to them. Each question is scored on a scale (0-5) with the first option "0" indicating the least amount of disability and "5" indicating the most severe disability. Higher scores indicate worse outcomes, lower scores indicate better outcomes. | 140 participants out of the 149 baseline participant population were analyzed since 9 participants were excluded due to incomplete Oswestry Disability Index data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 60 day, 1 year |
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Adverse Events not tracked and are inapplicable to this study.
Adverse Events not tracked and are inapplicable to this study.
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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 | Spine Fusion Participants | Patients undergoing lumbar spine fusion surgery for any indication. |
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Clinical variables were collected from SCOAP which is a quality improvement database and variables are not as reliable as research variables. It is unknown if participants that did not complete the surveys would have responded to surgery or not.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Cizik - Research Assistant Professor, Ph.D., M.P.H., | Surgical Outcomes Research Center - SORCE | 206-744-4631 | amorgan2@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 6, 2019 | May 8, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2019 | May 8, 2019 | SAP_001.pdf |
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| Seattle |
| Washington |
| 98122 |
| United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Confluence Health | Wenatchee | Washington | 98801 | United States |
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| Participants |
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| Sex: Female, Male | There is 1 missing. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Functional Limitations from back pain (ODI) | Oswestry Low Back Pain Disability Index (ODI) Total Score Scale 0-100 Sub-Scale Measures (0-5) for each: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. Interpretation: Simply add up your points for each section and plug it in to the following formula in order to calculate your level of disability: point total / 50 X 100 = % disability (aka: 'point total' divided by '50' multiply by ' 100 = percent disability) Lower values represent better outcomes. Higher values represent worse outcomes. | Mean | Standard Deviation | units on a scale |
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| Anxiety | PROMIS T Score: Total Anxiety Score 4 questions scaled 1-5 about anxiety, the raw score is the sum of these questions Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant. Lower values represent better outcomes. Higher values represent worse outcomes. | Mean | Standard Deviation | T-scores |
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| Depression | PROMIS T Score: Total Depression Score 4 questions scaled 1-5 about depression, the raw score is the sum of these questions Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant. Lower values represent better outcomes. Higher values represent worse outcomes. | Mean | Standard Deviation | T-scores |
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| Sleep | PROMIS T Score: Total Sleep Disturbance Score 4 questions scaled 1-5 about sleep disturbance, the raw score is the sum of these questions Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant. Lower values represent worse outcomes. Higher values represent better outcomes. | Mean | Standard Deviation | T-scores |
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| Pain chronicity | Count of Participants | Participants |
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| Pain interference | PROMIS T Score: Total Pain Interference Score 4 questions scaled 1-5 about pain interference, the raw score is the sum of these questions Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant. Lower values represent better outcomes. Higher values represent worse outcomes. | Mean | Standard Deviation | T-scores |
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| Pain catastrophizing (fear avoidance) | Count of Participants | Participants |
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| Alcohol, Marijuana Use | Count of Participants | Participants |
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| Asthma | Count of Participants | Participants |
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| Opioid/additional therapies use | Count of Participants | Participants |
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| Global health | PROMIS G02: general quality of life | Count of Participants | Participants |
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| Emotional support | PROMIS T Score: Total Emotional Support Score 4 questions scaled 1-5 about emotional support, the raw score is the sum of these questions Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant. Lower values represent better outcomes. Higher values represent worse outcomes. | Mean | Standard Deviation | T-scores |
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| Instrumental support | PROMIS T Score: Total Instrumental Support Score 4 questions scaled 1-5 about instrumental support, the raw score is the sum of these questions Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant. Lower values represent better outcomes. Higher values represent worse outcomes. | Mean | Standard Deviation | T-scores |
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| Radiculopathy | Count of Participants | Participants |
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| Spine Fusion Participants |
Patients undergoing lumbar spine fusion surgery for any indication. |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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