Trial Outcomes & Findings for Understanding Non-Response in Spine Fusion Surgery (NCT NCT02611479)
NCT ID: NCT02611479
Last Updated: 2019-05-30
Results Overview
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.
COMPLETED
184 participants
Baseline, 60 day, 1 year
2019-05-30
Participant Flow
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.
Participant milestones
| Measure |
Spine Fusion Participants
Patients undergoing lumbar spine fusion surgery for any indication.
|
|---|---|
|
Baseline Enrollment
STARTED
|
184
|
|
Baseline Enrollment
COMPLETED
|
171
|
|
Baseline Enrollment
NOT COMPLETED
|
13
|
|
Post-Surgery Follow-up at 30-90 Days
STARTED
|
171
|
|
Post-Surgery Follow-up at 30-90 Days
COMPLETED
|
169
|
|
Post-Surgery Follow-up at 30-90 Days
NOT COMPLETED
|
2
|
|
Post-Surgery Follow-up at 1-Year
STARTED
|
169
|
|
Post-Surgery Follow-up at 1-Year
COMPLETED
|
151
|
|
Post-Surgery Follow-up at 1-Year
NOT COMPLETED
|
18
|
|
Data Cleaning
STARTED
|
151
|
|
Data Cleaning
COMPLETED
|
149
|
|
Data Cleaning
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Spine Fusion Participants
Patients undergoing lumbar spine fusion surgery for any indication.
|
|---|---|
|
Baseline Enrollment
Exited study
|
13
|
|
Post-Surgery Follow-up at 30-90 Days
No surgery reported
|
2
|
|
Post-Surgery Follow-up at 1-Year
Lost to Follow-up
|
18
|
|
Data Cleaning
No baseline function or pain metrics
|
2
|
Baseline Characteristics
There is 1 missing.
Baseline characteristics by cohort
| Measure |
Spine Fusion Participants
n=149 Participants
Patients undergoing lumbar spine fusion surgery for any indication.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=149 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=149 Participants
|
|
Age, Categorical
>=65 years
|
78 Participants
n=149 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=148 Participants • There is 1 missing.
|
|
Sex: Female, Male
Male
|
65 Participants
n=148 Participants • There is 1 missing.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=149 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
144 Participants
n=149 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=149 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=149 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=149 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=149 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=149 Participants
|
|
Race (NIH/OMB)
White
|
140 Participants
n=149 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=149 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=149 Participants
|
|
Region of Enrollment
United States
|
149 participants
n=149 Participants
|
|
Functional Limitations from back pain (ODI)
|
41.3 units on a scale
STANDARD_DEVIATION 15.4 • n=149 Participants
|
|
Anxiety
|
55.0 T-scores
STANDARD_DEVIATION 9.2 • n=149 Participants
|
|
Depression
|
52.5 T-scores
STANDARD_DEVIATION 9.6 • n=149 Participants
|
|
Sleep
|
55.4 T-scores
STANDARD_DEVIATION 7.4 • n=149 Participants
|
|
Pain chronicity
1-3 months
|
1 Participants
n=149 Participants
|
|
Pain chronicity
3-6 months
|
4 Participants
n=149 Participants
|
|
Pain chronicity
6 months-1 year
|
19 Participants
n=149 Participants
|
|
Pain chronicity
1-5 years
|
39 Participants
n=149 Participants
|
|
Pain chronicity
More than 5 years
|
51 Participants
n=149 Participants
|
|
Pain chronicity
Missing
|
35 Participants
n=149 Participants
|
|
Pain interference
|
67.1 T-scores
STANDARD_DEVIATION 5.5 • n=149 Participants
|
|
Pain catastrophizing (fear avoidance)
Not at all
|
30 Participants
n=149 Participants
|
|
Pain catastrophizing (fear avoidance)
To a slight degree
|
38 Participants
n=149 Participants
|
|
Pain catastrophizing (fear avoidance)
To a moderate degree
|
38 Participants
n=149 Participants
|
|
Pain catastrophizing (fear avoidance)
To a great degree
|
28 Participants
n=149 Participants
|
|
Pain catastrophizing (fear avoidance)
All the time
|
11 Participants
n=149 Participants
|
|
Alcohol, Marijuana Use
Alcohol
|
42 Participants
n=149 Participants
|
|
Alcohol, Marijuana Use
Cannabis Use: Score Recoded
|
27 Participants
n=149 Participants
|
|
Alcohol, Marijuana Use
Missing
|
80 Participants
n=149 Participants
|
|
Asthma
No
|
106 Participants
n=149 Participants
|
|
Asthma
Yes
|
37 Participants
n=149 Participants
|
|
Asthma
Missing
|
6 Participants
n=149 Participants
|
|
Opioid/additional therapies use
|
88 Participants
n=149 Participants
|
|
Global health
Poor
|
9 Participants
n=149 Participants
|
|
Global health
Fair
|
43 Participants
n=149 Participants
|
|
Global health
Good
|
61 Participants
n=149 Participants
|
|
Global health
Very good
|
28 Participants
n=149 Participants
|
|
Global health
Excellent
|
8 Participants
n=149 Participants
|
|
Emotional support
|
54.8 T-scores
STANDARD_DEVIATION 8.1 • n=149 Participants
|
|
Instrumental support
|
55.2 T-scores
STANDARD_DEVIATION 8.8 • n=149 Participants
|
|
Radiculopathy
|
112 Participants
n=149 Participants
|
PRIMARY outcome
Timeframe: Baseline, 60 day, 1 yearPopulation: 140 participants out of the 149 baseline participant population were analyzed since 9 participants were excluded due to incomplete Oswestry Disability Index data.
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.
Outcome measures
| Measure |
Spine Fusion Participants
n=140 Participants
Patients undergoing lumbar spine fusion surgery for any indication.
|
|---|---|
|
Oswestry Disability Index
Baseline
|
41.3 score on a scale
Standard Deviation 15.4
|
|
Oswestry Disability Index
60-day
|
30.4 score on a scale
Standard Deviation 17.1
|
|
Oswestry Disability Index
12-month
|
19.4 score on a scale
Standard Deviation 17.3
|
Adverse Events
Spine Fusion Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Amy Cizik - Research Assistant Professor, Ph.D., M.P.H.,
Surgical Outcomes Research Center - SORCE
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place