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| Name | Class |
|---|---|
| Foot Levelers, Inc. | INDUSTRY |
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The purpose of this research study is to determine the change in perceived levels of pain and dysfunction in 50 patients with chronic low back pain, following the use of custom-made shoe orthotics for a three month period. The hypothesis of this study is that custom orthotic intervention will improve the patients' low back pain and dysfunction symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthotic group | Active Comparator | Subjects are asked to wear custom-made shoe orthotics for a 12 week study period. |
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| Shoe Orthotic Wait group | Other | The group serves as a cross-over control group. Subjects are asked to avoid any new therapies for the first 6 weeks of the 12 week study and during the last 6 weeks they are fitted for the custom-made shoe orthotics. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shoe orthotic | Device | Shoe orthotics are devices worn in the shoe to modify the patient's stance and gait. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | 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. | Randomization, Week 6, and Week 12 |
| Oswestry Disability Index (ODI) | 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. | Randomization, Week 6, and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerrilyn Cambron, DC, MPH, PhD | National University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Health Sciences | Lombard | Illinois | 60148 | United States |
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.
We recruited 50 patients with chronic low back pain through media advertising in a midwestern suburban area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Orthotic Group | This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Orthotic Group | This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale (VAS) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Randomization, Week 6, and Week 12 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Orthotic Group | This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks. |
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Subjects and clinicians were not blind to group. Subjects came from 1 region of the US, majority were white and ~50 years old. One type of orthotic was used as the only form of care. Several subjects felt discomfort/stiffness rather than pain.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jerrilyn Cambron | National University of Health Sciences | 630-889-6536 | jcambron@nuhs.edu |
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| ID | Term |
|---|---|
| D061826 | Foot Orthoses |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Shoe Orthotic Wait Group | Device | This group receives the custom-made shoe orthotics at week 6 of the 12 week treatment program rather than week 1. |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Oswestry Disability Index (ODI) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Randomization, Week 6, and Week 12 |
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| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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. | 0 | 25 | 0 | 25 |
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| Week 12 |
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Group differences in ODI for low back pain from randomization visit to 12-week visit were assessed using the Wilcoxon rank sums test. |
| .0336 |
| 1-Sided |
| 95 |
| Superiority or Other |