Effect Mechanism of Custom-made Foot Orthoses in Patients With Chronic Low Back Pain
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Custom-made foot orthoses treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks |
Device: 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)
|
| Placebo Comparator: Placebo a flat insole for a period of 4 weeks |
Device: 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)
|
Outcome Measures
Primary Outcome Measures
- Assess chronic low back pain [At the moment of inclusion in the study]
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.
- Assess chronic low back pain [At the moment of inclusion in the study]
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
- Assess the position of the foot [At the moment of inclusion in the study]
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.
- Assess chronic low back pain [After four weeks of use of the orthose treatment.]
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.
- Assess chronic low back pain [After four weeks of use of the orthose treatment.]
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
- Assess the position of the foot [After four weeks of use of the orthose treatment.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males and females between 18 and 65 years old
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Presence of CLBP
-
Foot Posture Index pronated in one or both feet (henceforth, FPI) ≥ +6
Exclusion Criteria:
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Serious illness
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Current participation in another research study
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Pregnancy
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Previous back or foot surgery
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Current treatment of foot pathology or back, and leg length discrepancy > 5 mm
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Manuel Pabón Carrasco | Seville | Spain |
Sponsors and Collaborators
- University of Seville
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRESEUE-Foot