Trial Outcomes & Findings for Aging Back Clinics (NCT NCT03564600)
NCT ID: NCT03564600
Last Updated: 2025-03-20
Results Overview
The ODI assesses interference of pain with function. This questionnaire is used by clinicians and researchers to quantify disability for low back pain. Range 0 to 100 with higher score indicating greater disability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
299 participants
Primary outcome timeframe
Baseline visit, every three months for up to one year
Results posted on
2025-03-20
Participant Flow
Participant milestones
| Measure |
ABC Group
Veterans with back pain for at least the past 6 months receive personalized care by providers trained based on a published set of algorithms that guide care for conditions that contribute to disability in older adults with chronic low back pain
Aging Back Clinics management: Personalized care is delivered that is guided by published algorithms for each component condition identified by a trained provider.
|
UC Group
Veterans with back pain for at least the past 6 months who receive usual care as directed by their primary care physician.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
149
|
|
Overall Study
COMPLETED
|
113
|
99
|
|
Overall Study
NOT COMPLETED
|
37
|
50
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aging Back Clinics
Baseline characteristics by cohort
| Measure |
ABC Group
n=150 Participants
Veterans with back pain for at least the past 6 months receive personalized care by providers trained based on a published set of algorithms that guide care for conditions that contribute to disability in older adults with chronic low back pain
Aging Back Clinics management: Personalized care is delivered that is guided by published algorithms for each component condition identified by a trained provider.
|
UC Group
n=149 Participants
Veterans with back pain for at least the past 6 months who receive usual care as directed by their primary care physician.
|
Total
n=299 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
150 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
299 Participants
n=5 Participants
|
|
Age, Continuous
|
73.5 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
73.3 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
73.39 years
STANDARD_DEVIATION 5.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
139 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
150 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
299 Participants
n=5 Participants
|
|
Oswestry Disability Index
|
30.5 units on a scale
STANDARD_DEVIATION 14.7 • n=5 Participants
|
33.1 units on a scale
STANDARD_DEVIATION 15.3 • n=7 Participants
|
31.8 units on a scale
STANDARD_DEVIATION 15.02 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline visit, every three months for up to one yearThe ODI assesses interference of pain with function. This questionnaire is used by clinicians and researchers to quantify disability for low back pain. Range 0 to 100 with higher score indicating greater disability.
Outcome measures
| Measure |
ABC Group
n=150 Participants
Veterans with back pain for at least the past 6 months receive personalized care by providers trained based on a published set of algorithms that guide care for conditions that contribute to disability in older adults with chronic low back pain
Aging Back Clinics management: Personalized care is delivered that is guided by published algorithms for each component condition identified by a trained provider.
|
UC Group
n=149 Participants
Veterans with back pain for at least the past 6 months who receive usual care as directed by their primary care physician.
|
|---|---|---|
|
Oswestry Disability Index (ODI) Change
3 months
|
-0.4 units on a scale
Standard Deviation 13.0
|
2.7 units on a scale
Standard Deviation 11.3
|
|
Oswestry Disability Index (ODI) Change
6 months
|
-0.8 units on a scale
Standard Deviation 12.0
|
1.2 units on a scale
Standard Deviation 11.5
|
|
Oswestry Disability Index (ODI) Change
9 months
|
1.3 units on a scale
Standard Deviation 14.7
|
-0.2 units on a scale
Standard Deviation 12.6
|
|
Oswestry Disability Index (ODI) Change
12 months
|
0.2 units on a scale
Standard Deviation 14.0
|
2.8 units on a scale
Standard Deviation 12.1
|
Adverse Events
ABC Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UC Group
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
Professor Debra K. Weiner, M.D.
University of Pittsburgh School of Medicine
Phone: 4124016811
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place