Trial Outcomes & Findings for Orthotic Use for Chronic Low Back Pain (NCT NCT00976664)
NCT ID: NCT00976664
Last Updated: 2017-05-03
Results Overview
This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain.
COMPLETED
NA
50 participants
Randomization, Week 6, and Week 12
2017-05-03
Participant Flow
We recruited 50 patients with chronic low back pain through media advertising in a midwestern suburban area.
143 people were screened by phone, eligible patients (58) attended a baseline visit. Subjects were eligible if they were 18+ years of age and symptomatic with pain between T12-S1 joints with or without radiating pain for at least 3 months. Patients were randomized to a treatment group receiving custom-made orthotics or a wait-list control group.
Participant milestones
| Measure |
Orthotic Group
This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
|
Wait Group
This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Orthotic Use for Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Orthotic Group
n=25 Participants
This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
|
Wait Group
n=25 Participants
This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, Customized
|
51 years
STANDARD_DEVIATION 16 • n=5 Participants
|
53 years
STANDARD_DEVIATION 16 • n=7 Participants
|
52 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization, Week 6, and Week 12Population: Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.
This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain.
Outcome measures
| Measure |
Orthotic Group
n=22 Participants
This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
|
Wait Group
n=24 Participants
This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
|
|---|---|---|
|
Visual Analog Scale (VAS)
Randomization
|
5.0 units on a scale
Standard Deviation 2.2
|
4.3 units on a scale
Standard Deviation 1.9
|
|
Visual Analog Scale (VAS)
Week 6
|
2.8 units on a scale
Standard Deviation 2.6
|
4.1 units on a scale
Standard Deviation 2.3
|
|
Visual Analog Scale (VAS)
Week 12
|
2.7 units on a scale
Standard Deviation 2.5
|
2.9 units on a scale
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Randomization, Week 6, and Week 12Population: Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.
This index measures the functional disability of the subject, points on this index can range from 0-50. A higher numeric value on this scale indicates a worse outcome or increased disability (e.g. 0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling). Absolute scores are reported in the data table.
Outcome measures
| Measure |
Orthotic Group
n=22 Participants
This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
|
Wait Group
n=24 Participants
This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
|
|---|---|---|
|
Oswestry Disability Index (ODI)
Randomization
|
10.0 units on a scale
Standard Deviation 4.9
|
10.4 units on a scale
Standard Deviation 5.8
|
|
Oswestry Disability Index (ODI)
Week 6
|
6.2 units on a scale
Standard Deviation 5.2
|
10.2 units on a scale
Standard Deviation 5.4
|
|
Oswestry Disability Index (ODI)
Week 12
|
6.1 units on a scale
Standard Deviation 5.3
|
8.9 units on a scale
Standard Deviation 5.5
|
Adverse Events
Orthotic Group
Wait Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jerrilyn Cambron
National University of Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place