Trial Outcomes & Findings for Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis (NCT NCT02260401)
NCT ID: NCT02260401
Last Updated: 2017-06-16
Results Overview
We will measure whether or not providing these individualized reports to patients impacts patients decision-making regarding use of epidural steroid injections between 18 and 24 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
165 participants
Primary outcome timeframe
24 months
Results posted on
2017-06-16
Participant Flow
Participant milestones
| Measure |
Individualized Report
Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.
Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)
|
Individualized Reports After 24 Months
Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
85
|
|
Overall Study
COMPLETED
|
75
|
73
|
|
Overall Study
NOT COMPLETED
|
5
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis
Baseline characteristics by cohort
| Measure |
Individualized Report
n=80 Participants
Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.
Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)
|
Individualized Reports After 24 Months
n=85 Participants
Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 10 • n=5 Participants
|
69.1 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
67.8 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsWe will measure whether or not providing these individualized reports to patients impacts patients decision-making regarding use of epidural steroid injections between 18 and 24 months
Outcome measures
| Measure |
Individualized Report
n=80 Participants
Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.
Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)
|
Individualized Reports After 24 Months
n=85 Participants
Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
|
|---|---|---|
|
Utilization of ESI
|
3.6 number of ESI between 18-24 months
Standard Deviation 2.0
|
3.3 number of ESI between 18-24 months
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 24 monthsWe will determine if providing individualized reports to the LESS trial participants at 198 months impacts healthcare utilization for spinal stenosis between 18 and 24 months (including doctors visits, physical therapy, surgery, opioid use)
Outcome measures
Outcome data not reported
Adverse Events
Individualized Report
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individualized Reports After 24 Months
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place