Spine Fusion
Conditions
Keywords
patient reported outcomes
Brief summary
To identify patient characteristics associated with non-response after spine fusion surgery for the treatment of degenerative disc disease (DDD).
Interventions
None listed
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Washington
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has diagnosis of degenerative disc disease * Subject is undergoing lumbar spine fusion surgery
Exclusion criteria
* Subject is less than 18 years of age * Subject is not fluent in English * Subject requires a caretaker for medical decision making
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index | Baseline, 60 day, 1 year | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Spine Fusion Participants Patients undergoing lumbar spine fusion surgery for any indication. | 149 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Baseline Enrollment | Exited study | 13 |
| Data Cleaning | No baseline function or pain metrics | 2 |
| Post-Surgery Follow-up at 1-Year | Lost to Follow-up | 18 |
| Post-Surgery Follow-up at 30-90 Days | No surgery reported | 2 |
Baseline characteristics
| Characteristic | Spine Fusion Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 78 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants |
| Alcohol, Marijuana Use Alcohol | 42 Participants |
| Alcohol, Marijuana Use Cannabis Use: Score Recoded | 27 Participants |
| Alcohol, Marijuana Use Missing | 80 Participants |
| Anxiety | 55.0 T-scores STANDARD_DEVIATION 9.2 |
| Asthma Missing | 6 Participants |
| Asthma No | 106 Participants |
| Asthma Yes | 37 Participants |
| Depression | 52.5 T-scores STANDARD_DEVIATION 9.6 |
| Emotional support | 54.8 T-scores STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 144 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Functional Limitations from back pain (ODI) | 41.3 units on a scale STANDARD_DEVIATION 15.4 |
| Global health Excellent | 8 Participants |
| Global health Fair | 43 Participants |
| Global health Good | 61 Participants |
| Global health Poor | 9 Participants |
| Global health Very good | 28 Participants |
| Instrumental support | 55.2 T-scores STANDARD_DEVIATION 8.8 |
| Opioid/additional therapies use | 88 Participants |
| Pain catastrophizing (fear avoidance) All the time | 11 Participants |
| Pain catastrophizing (fear avoidance) Not at all | 30 Participants |
| Pain catastrophizing (fear avoidance) To a great degree | 28 Participants |
| Pain catastrophizing (fear avoidance) To a moderate degree | 38 Participants |
| Pain catastrophizing (fear avoidance) To a slight degree | 38 Participants |
| Pain chronicity 1-3 months | 1 Participants |
| Pain chronicity 1-5 years | 39 Participants |
| Pain chronicity 3-6 months | 4 Participants |
| Pain chronicity 6 months-1 year | 19 Participants |
| Pain chronicity Missing | 35 Participants |
| Pain chronicity More than 5 years | 51 Participants |
| Pain interference | 67.1 T-scores STANDARD_DEVIATION 5.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 140 Participants |
| Radiculopathy | 112 Participants |
| Region of Enrollment United States | 149 participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 65 Participants |
| Sleep | 55.4 T-scores STANDARD_DEVIATION 7.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Baseline, 60 day, 1 year
Population: 140 participants out of the 149 baseline participant population were analyzed since 9 participants were excluded due to incomplete Oswestry Disability Index data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spine Fusion Participants | Oswestry Disability Index | Baseline | 41.3 score on a scale | Standard Deviation 15.4 |
| Spine Fusion Participants | Oswestry Disability Index | 60-day | 30.4 score on a scale | Standard Deviation 17.1 |
| Spine Fusion Participants | Oswestry Disability Index | 12-month | 19.4 score on a scale | Standard Deviation 17.3 |