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Purpose of study: To assess the effects of wearing custom orthotics as opposed to placebo foot inserts on the duration of chiropractic correction of spinal fixations and muscle imbalances using applied kinesiology techniques.
Participants with chronic lower back pain of greater than one month duration will be randomized to receive custom foot orthotics or placebo flat inserts. Both groups will receive chiropractic treatment 5 times over the course of 4 weeks following receipt of orthotics. Subjects and treating doctor will be blind to the insert type. Patients will report present, average, best and worst pain at each visit, and complete a Roland-Morris questionnaire. Secondary outcome measures will be number of fixated vertebral levels identified by motion palpation and challenge and number of muscles testing grade 4 and below from a list of 5 muscles to be tested bilaterally before and after each treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention, Custom Orthotics | Active Comparator | Wearing custom foot orthotics |
|
| Sham Foot Orthotic | Sham Comparator | Wearing sham or flat shoe insoles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| foot orthotics | Device | Experimental wore experimental orthotics throughout the study period as much of the day as possible. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quadruple Visual Analog Pain Scale | Pain present, best worst and average on a scale of 0 to 10, with 10 being the worst imaginable. | Six weeks |
| Roland-Morris Questionnaire | Questionnaire listing activities of daily living, impacted by low back pain. | Six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of fixated vertebral levels | Number of vertebral levels found to be fixated as determined by motion palpation and vertebral challenge. | Six weeks |
| Number of tested muscles grade 4 and below |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katharine Conable, DC | Logan College of Chiropractic/University Programs | Principal Investigator |
| Anthony Rosner, PhD | International College of Applied Kinesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Logan College of Chiropractic/University Programs | Chesterfield | Missouri | 63017 | United States |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Sham foot orthotic | Device | Control group wore sham insoles as much of the time as possible for the duration of the study period. |
|
|
Number of five muscles tested bilaterally, which tested grade 4 or below in manual muscle testing.
| Six weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |