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Excessive foot pronation has been recognized as being linked to chronic low back pain (CLBP). The use of compensating custom-made foot orthoses has not been entirely explored as an effective therapy for CLBP Objective: to investigate the effects of wearing custom made foot orthoses compared to placebo orthoses in patients with pronated feet and chronic low back pain (CLBP).
Excessive foot pronation has been recognized as being linked to CLBP. Foot hyperpronation may cause malalignment of the lower extremity.There is a wide variety of treatments for CLBP, and it is suggested that excessive pronation of the foot has been linked to CLBP.The use of compensating custom-made foot orthoses has not been entirely explored as an effective therapy for CLBP.
Customized foot orthoses alter the position of the foot during weight-bearing. The goal is to eliminate compensation of the foot due to structural deformity or misalignment and redistribute abnormal plantar pressures.Custom-made foot orthoses may contribute to improving chronic low back pain. This question represents an important benefit for patients and for the public health system by reducing expensive treatments, such as surgery or long periods of rehabilitation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custom-made foot orthoses | Experimental | treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks |
|
| Placebo | Placebo Comparator | a flat insole for a period of 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom-made foot orthoses Versus a flat insole | Device | Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index Questionnaire(ODI) for Lower Back Pain | This questionnaire has been designed to give us information as to how your back or leg pain is affecting your ability to manage in everyday life.The test is considered the 'gold standard' of low back functional outcome tools 0% to 20%: minimal disability: The patient can cope with most living activities. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%: These patients are either bed-bound or exaggerating their symptoms. | Baseline |
| VAS for Chronic Low Back Pain | 10 visual analogue scale (VAS).The findings suggested that 10 VAS ratings of no pain (0-2), mild pain(2-4), moderate pain (4-7), and severe pain (7-10) | Baseline |
| Foot Posture Index | Foot posture was assessed by a podiatrist during the biomechanical assessment based on the six-item foot posture index (FPI≥+6). The FPI consists of six validated items that are measured in a relaxed standing position of the subject. Each item is assessed on a -2 to +2 scale, where -2 indicates a supinated position, 0 indicates a neutral position and +2 indicates a pronated position, depending on the specific item. The sum of the scores of the six items provides a total score ranging from -12 to +12. | At the moment of inclusion in the study |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index Questionnaire (ODI) | Oswestry Disability Index Questionnaire (ODI) for chronic low back pain | at the end of the study, approximately 4 weeks |
| VAS | VAS scale for CLBP Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| university. Departament of Podiatry | Seville | 41009 | Spain | |||
| Manuel Pabón Carrasco |
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Participants are excluded if they have a pregnancy during the study. Pregnancy modifies the curvature of the back.
All those processes that alter the physiology of the musculoskeletal system will also be excluded.
. The random allocation to each group was done by a collaborating researcher who established the sequence based on a random numbers table and then the treatment was administered (experimental/control).
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| ID | Title | Description |
|---|---|---|
| FG000 | Custom-made Foot Orthoses | treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group) |
| FG001 | Placebo | a flat insole for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
101 patients with nonspecific CLBP and a pronated foot posture index (FPI) was studied. Randomized in two groups, an experimental one n= 53, used custom-made foot orthotics and the control group n=48 treated with non-biomechanical effect orthoses
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| ID | Title | Description |
|---|---|---|
| BG000 | Custom-made Foot Orthoses | treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group) |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Oswestry Disability Index Questionnaire(ODI) for Lower Back Pain | This questionnaire has been designed to give us information as to how your back or leg pain is affecting your ability to manage in everyday life.The test is considered the 'gold standard' of low back functional outcome tools 0% to 20%: minimal disability: The patient can cope with most living activities. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%: These patients are either bed-bound or exaggerating their symptoms. | Posted | Mean | Standard Deviation | Score on 0-100% scale | Baseline |
|
Adversor effects are valued for one months.
The use of plantar supports does not result in participant mortality or serious adverse effects.
Non-serious adverse effects are monitored.
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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 | Custom-made Foot Orthoses | treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group) |
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The sample size should be expanded.
Treatment follow-up is difficult to assess (the patient goes home with treatment)
Future studies are necessary
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manuel Pabón-Carrasco | Universidad de Sevilla | 954 350 997 | +34 | mpabon2@us.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2019 | Jun 4, 2020 | Prot_SAP_000.pdf |
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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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| At 4 weeks after baseline |
| Seville |
| Spain |
a flat insole for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group) |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Oswestry's Disability Index Questionnaire | 0% to 20%: minimal disability 21%-40%: moderate disability 41%-60%: severe disability. 61%-80%: crippled 81%-100%: These patients are either bed-bound or exaggerating their symptoms. | Mean | Standard Deviation | units on a scale Minimum 0% Maximum 100 |
|
| visual analogue scale (VAS) | no pain (0-2), mild pain(2-4), moderate pain (4-7), and severe pain (7-10) | Median | Standard Deviation | units on a scale Minimum 0 Maximum 10 |
|
| OG000 |
| Custom-made Foot Orthoses |
treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group) |
| OG001 | Placebo | a flat insole for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group) |
|
|
| Primary | VAS for Chronic Low Back Pain | 10 visual analogue scale (VAS).The findings suggested that 10 VAS ratings of no pain (0-2), mild pain(2-4), moderate pain (4-7), and severe pain (7-10) | The groups are expected to be similar in gender, sex, age, pain at first (VAS and ODI) and at the time of the initial examination.This would allow a comparison avoiding risk of bias. | Posted | Mean | Standard Deviation | Score on 0-10 scale | Baseline |
|
|
|
| Primary | Foot Posture Index | Foot posture was assessed by a podiatrist during the biomechanical assessment based on the six-item foot posture index (FPI≥+6). The FPI consists of six validated items that are measured in a relaxed standing position of the subject. Each item is assessed on a -2 to +2 scale, where -2 indicates a supinated position, 0 indicates a neutral position and +2 indicates a pronated position, depending on the specific item. The sum of the scores of the six items provides a total score ranging from -12 to +12. | Posted | Mean | Standard Deviation | Score on -12 to +12 scale | At the moment of inclusion in the study |
|
|
|
| Secondary | Oswestry Disability Index Questionnaire (ODI) | Oswestry Disability Index Questionnaire (ODI) for chronic low back pain | Posted | Mean | Standard Deviation | Score on 0-100% scale | at the end of the study, approximately 4 weeks |
|
|
|
| Secondary | VAS | VAS scale for CLBP Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity. | Posted | Mean | Standard Deviation | points on a 0-10 Visual Analogue Scale | At 4 weeks after baseline |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Placebo | a flat insole for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group) | 0 | 52 | 0 | 52 | 0 | 52 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |