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Purpose: excessive foot pronation has been reported as being related to chronic low back symptoms. Compensating custom-made foot orthotics treatment has not been entirely explored as an effective therapy for chronic low back pain (CLBP). This study aims to observe the effects of custom made foot orthoses, in subjects with foot pronation suffering from CLBP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custom-made plantar orthosis (3 mm polyurethane foam + 3 mm polypropylene) | Experimental | Individually manufactured plantar orthosis, moulded to each patient's pronated foot using 3 mm polyurethane foam laminated with 3 mm polypropylene, designed to control excessive pronation and thus potentially alleviate non-specific chronic low back pain. |
|
| Arm/Group Title: Placebo Comparator: Flat insole (placebo orthosis) (3 mm polyurethane foam) | Placebo Comparator | Flat insole made of 3 mm polyurethane foam without corrective elements, used as a placebo comparator to the custom-made orthosis in the management of non-specific chronic low back pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foot Orthoses | Device | To compare the use of handmade plantar orthoses versus the use of splints in the management of low back pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in disability due to low back pain measured by the Roland-Morris Disability Questionnaire (RMDQ) | The RMDQ is a 24-item self-reported questionnaire designed to assess physical disability due to low back pain. Scores range from 0 to 24, with higher scores indicating greater disability. | Baseline and 4 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity measured by the Numerical Rating Scale (NRS, 0-10) | The NRS is a 0-10 scale where 0 = no pain and 10 = worst imaginable pain. | Baseline and 4 weeks |
| Change in foot posture measured by the Foot Posture Index (FPI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Sevilla | Seville | sevilla | 41008 | Spain |
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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 |
|---|---|
| D061826 | Foot Orthoses |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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The FPI is a 6-item clinical tool for quantifying foot posture. Total scores range from -12 (highly supinated) to +12 (highly pronated).
| Baseline and 4 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |