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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
| Foot Levelers, Inc. | INDUSTRY |
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The goal of this randomized clinical study is to assess pain and dysfunction in 225 volunteer subjects who have chronic low back pain.
The hypothesis of this study is that custom-made shoe will improve patients' low back pain and dysfunction. Additionally, custom-made shoe orthotics plus chiropractic treatment will further improve patients' low back pain and dysfunction while maintaining that improvement during the one year study follow-up period.
Specific Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthotics | Active Comparator | Subjects are asked to wear custom-made shoe orthotics for a 12 week study period. |
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| Orthotics Plus Chiropractic Care | Active Comparator | Subjects are asked to wear custom-made shoe orthotics for a 12 week study period in addition to receiving Chiropractic Care 1-4 times per week during the first 6 weeks of the 12 week study period. |
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| Wait List | 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 six weeks they are fitted for the custom-made shoe orthotics. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthotics | Other |
| ||
| Orthotics Plus Chiropractic Care |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | The Numeric Pain Rating Scale (NPRS) is a numeric scale from 0-10, wherein patients can select (by circling or otherwise selecting) the one number along that line that best describes the pain being inquired about during the specified time period. The NPRS is one of the most frequently used methods for the measurement of clinical pain. | This primary outcome measure will be collected at the Randomization Visit and Week 6. |
| Modified Oswestry Disability Index (MODI) | The Modified Oswestry Disability Index, a condition specific questionnaire covering 10 areas of daily living and expressing the degree of disability as a percentage. The measured areas include: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment. Each category is scored on a continuum from 0 to 5 points, for a possible total score of 50 out of 50, popularly described as "100% disability." | This primary outcome measure will be collected at the Randomization Visit and Week 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | This outcome will also be collected at secondary time points which include additional bi-weekly time points during care at Weeks 2, 4, 8, 10, and 12; as well as, 3, 6, and 12 months post-care. | |
| Modified Oswestry Disability Index (MODI) |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28465224 | Derived | Cambron JA, Dexheimer JM, Duarte M, Freels S. Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Sep;98(9):1752-1762. doi: 10.1016/j.apmr.2017.03.028. Epub 2017 Apr 30. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D001915 | Braces |
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Other |
The six week Chiropractic Care portion of this intervention may include the use of ice packs, hot packs, massage, and chiropractic manipulations to the spine or lower extremities (utilizing High Velocity Low Amplitude and/or Flexion Distraction manipulations). |
|
| Wait List | Other |
|
| This outcome will also be collected at secondary time points which include additional bi-weekly time points during care at Weeks 2, 4, 8, 10, and 12; as well as, 3, 6, and 12 months post-care. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001071 |
| Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |