Trial Outcomes & Findings for Benefit of Lumbar Bracing for Chronic Low Back Pain Due to Degenerative Disc Disease (NCT NCT03484403)
NCT ID: NCT03484403
Last Updated: 2024-01-08
Results Overview
Patients rate their weekly pain on a scale from 0-10. Lower values indicate better outcomes. Average weekly pain scores were compared from baseline to 6 week mark.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
Change between baseline and each week for 6 weeks
Results posted on
2024-01-08
Participant Flow
Participants with a diagnosis of lumbar degenerative disc disease or joint disease were recruited from the Physical Medicine and Rehabilitation clinic at the Veterans Affairs Medical Center, and were included in the study if they met the study criteria.
2 participants withdrew after enrollment
Participant milestones
| Measure |
Control Group
Study participants will not receive a back brace but will receive back school education and the same physical therapy exercise instruction as the treatment group.
Back school: Back school consists of patient education physical therapy exercise instruction.
|
Treatment Group
Study participants in this group will receive a lumbar support back brace and will receive back school education and the same physical therapy exercise instruction as the control group.
Lumbar back brace: A brace that supports the lumbar region of the spine.
Back school: Back school consists of patient education physical therapy exercise instruction.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
25
|
|
Overall Study
COMPLETED
|
28
|
21
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Control Group
Study participants will not receive a back brace but will receive back school education and the same physical therapy exercise instruction as the treatment group.
Back school: Back school consists of patient education physical therapy exercise instruction.
|
Treatment Group
Study participants in this group will receive a lumbar support back brace and will receive back school education and the same physical therapy exercise instruction as the control group.
Lumbar back brace: A brace that supports the lumbar region of the spine.
Back school: Back school consists of patient education physical therapy exercise instruction.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
Baseline Characteristics
Benefit of Lumbar Bracing for Chronic Low Back Pain Due to Degenerative Disc Disease
Baseline characteristics by cohort
| Measure |
Control Group
n=34 Participants
Study participants will not receive a back brace but will receive back school education and the same physical therapy exercise instruction as the treatment group.
Back school: Back school consists of patient education physical therapy exercise instruction.
|
Treatment Group
n=25 Participants
Study participants in this group will receive a lumbar support back brace and will receive back school education and the same physical therapy exercise instruction as the control group.
Lumbar back brace: A brace that supports the lumbar region of the spine.
Back school: Back school consists of patient education physical therapy exercise instruction.
|
Total
n=59 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
|
30 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
48.9 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
25 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Pain Disability Questionnaire
|
79.26 units on a scale
STANDARD_DEVIATION 23.29 • n=5 Participants
|
80.65 units on a scale
STANDARD_DEVIATION 23.33 • n=7 Participants
|
79.96 units on a scale
STANDARD_DEVIATION 23.31 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change between baseline and each week for 6 weeksPatients rate their weekly pain on a scale from 0-10. Lower values indicate better outcomes. Average weekly pain scores were compared from baseline to 6 week mark.
Outcome measures
| Measure |
Control Group
n=34 Participants
Study participants will not receive a back brace but will receive back school education and the same physical therapy exercise instruction as the treatment group.
Back school: Back school consists of patient education physical therapy exercise instruction.
|
Treatment Group
n=25 Participants
Study participants in this group will receive a lumbar support back brace and will receive back school education and the same physical therapy exercise instruction as the control group.
Lumbar back brace: A brace that supports the lumbar region of the spine.
Back school: Back school consists of patient education physical therapy exercise instruction.
|
|---|---|---|
|
Pain Diary
|
6.71 units on a scale
Standard Deviation 1.56
|
5 units on a scale
Standard Deviation 1.78
|
PRIMARY outcome
Timeframe: These assessments were made at baseline (T₀), 6 wks (T₁), 12 wks (T₂), and 6 mos (T₃). Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months).Measures how pain affects the patients lifestyle and participation in activities. Ranges from 0-150. Higher values indicate worse outcome.
Outcome measures
| Measure |
Control Group
n=34 Participants
Study participants will not receive a back brace but will receive back school education and the same physical therapy exercise instruction as the treatment group.
Back school: Back school consists of patient education physical therapy exercise instruction.
|
Treatment Group
n=25 Participants
Study participants in this group will receive a lumbar support back brace and will receive back school education and the same physical therapy exercise instruction as the control group.
Lumbar back brace: A brace that supports the lumbar region of the spine.
Back school: Back school consists of patient education physical therapy exercise instruction.
|
|---|---|---|
|
Pain Disability Questionnaire
Baseline
|
79.26 units on a scale
Standard Deviation 23.29
|
80.65 units on a scale
Standard Deviation 23.33
|
|
Pain Disability Questionnaire
6-weeks
|
73 units on a scale
Standard Deviation 24
|
78.2 units on a scale
Standard Deviation 24
|
|
Pain Disability Questionnaire
12-weeks
|
68 units on a scale
Standard Deviation 24
|
79.2 units on a scale
Standard Deviation 25
|
|
Pain Disability Questionnaire
6-months
|
59.6 units on a scale
Standard Deviation 25
|
80 units on a scale
Standard Deviation 25.1
|
PRIMARY outcome
Timeframe: Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months)Patient reported outcome measure that measures how their pain problem is interfering with their quality of life and function. Higher scores indicate worse outcomes. Higher scores = more pain interference with function, range = 0-112
Outcome measures
| Measure |
Control Group
n=34 Participants
Study participants will not receive a back brace but will receive back school education and the same physical therapy exercise instruction as the treatment group.
Back school: Back school consists of patient education physical therapy exercise instruction.
|
Treatment Group
n=25 Participants
Study participants in this group will receive a lumbar support back brace and will receive back school education and the same physical therapy exercise instruction as the control group.
Lumbar back brace: A brace that supports the lumbar region of the spine.
Back school: Back school consists of patient education physical therapy exercise instruction.
|
|---|---|---|
|
PROMIS Instrument Questionnaire
6-months
|
42.2 units on a scale
Standard Deviation 22.2
|
61.9 units on a scale
Standard Deviation 24
|
|
PROMIS Instrument Questionnaire
Baseline
|
53.82 units on a scale
Standard Deviation 20.74
|
52.7 units on a scale
Standard Deviation 18.37
|
|
PROMIS Instrument Questionnaire
6-weeks
|
49 units on a scale
Standard Deviation 21
|
53 units on a scale
Standard Deviation 19
|
|
PROMIS Instrument Questionnaire
12-weeks
|
47 units on a scale
Standard Deviation 21.2
|
56 units on a scale
Standard Deviation 22
|
PRIMARY outcome
Timeframe: Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months)Measures quality of life for pre- and post comparisons. Higher scores indicate better outcomes. higher scores = poorer quality of life, range = 0-10
Outcome measures
| Measure |
Control Group
n=34 Participants
Study participants will not receive a back brace but will receive back school education and the same physical therapy exercise instruction as the treatment group.
Back school: Back school consists of patient education physical therapy exercise instruction.
|
Treatment Group
n=25 Participants
Study participants in this group will receive a lumbar support back brace and will receive back school education and the same physical therapy exercise instruction as the control group.
Lumbar back brace: A brace that supports the lumbar region of the spine.
Back school: Back school consists of patient education physical therapy exercise instruction.
|
|---|---|---|
|
European Qualify of Life (EQ-5D) Questionnaire
Baseline
|
3.82 units on a scale
Standard Deviation 1.6
|
4.13 units on a scale
Standard Deviation 1.75
|
|
European Qualify of Life (EQ-5D) Questionnaire
6-weeks
|
3.6 units on a scale
Standard Deviation 1.5
|
4.3 units on a scale
Standard Deviation 1.8
|
|
European Qualify of Life (EQ-5D) Questionnaire
12-weeks
|
3.4 units on a scale
Standard Deviation 1.7
|
4.8 units on a scale
Standard Deviation 1.9
|
|
European Qualify of Life (EQ-5D) Questionnaire
6-months
|
3 units on a scale
Standard Deviation 1.5
|
5 units on a scale
Standard Deviation 2.2
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place