Effect Mechanism of Custom-made Foot Orthoses in Patients With Chronic Low Back Pain

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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Effect Mechanism of Custom-made Foot Orthoses on Foot Pronation Subjects and Chronic Low Back Pain: a Randomized Controlled Trial

Conditions
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Chronic Low Back Pain, Foot Pronation

Intervention / Treatment
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* Device: Custom-made foot orthoses Versus a flat insole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females between 18 and 65 years old Presence of CLBP Foot Posture Index pronated in one or both feet (henceforth, FPI) ≥ +6 Exclusion Criteria: Serious illness Current participation in another research study Pregnancy Previous back or foot surgery Current treatment of foot pathology or back, and leg length discrepancy > 5 mm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Custom-made foot orthoses<br>treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks | Device: Custom-made foot orthoses Versus a flat insole<br>* Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)<br>|
| Placebo Comparator: Placebo<br>a flat insole for a period of 4 weeks | Device: Custom-made foot orthoses Versus a flat insole<br>* Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess chronic low back pain | Oswestry Disability Index Questionnaire (ODI) .Interpretation of scores 0% to 20%: minimal disability: The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 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. | At the moment of inclusion in the study | 
| Assess chronic low back pain | 100 mm visual analogue scale (VAS).The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain | At the moment of inclusion in the study | 
| Assess the position of the foot | A podiatrist assessed the foot posture during the biomechanical assessment based on the six-item foot posture index (FPI≥+6) 16. The FPI consists of six validated items measured in a standing relaxed position of the subject; The categories are: Supinated foot: -1 a -12. Neutral foot posture: 0 to +5 (neutral). Pronated foot posture: +6 to +12. | At the moment of inclusion in the study | 
| Assess chronic low back pain | Oswestry Disability Index Questionnaire (ODI) .Interpretation of scores 0% to 20%: minimal disability: The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 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. | After four weeks of use of the orthose treatment. | 
| Assess chronic low back pain | 100 mm visual analogue scale (VAS).The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain | After four weeks of use of the orthose treatment. | 
| Assess the position of the foot | A podiatrist assessed the foot posture during the biomechanical assessment based on the six-item foot posture index (FPI≥+6) 16. The FPI consists of six validated items measured in a standing relaxed position of the subject; The categories are: Supinated foot: -1 a -12. Neutral foot posture: 0 to +5 (neutral). Pronated foot posture: +6 to +12. | After four weeks of use of the orthose treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, custom-made foot orthoses, Foot, pronation, posture