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出境医 / 临床实验 / Effect Mechanism of Custom-made Foot Orthoses in Patients With Chronic Low Back Pain
Effect Mechanism of Custom-made Foot Orthoses in Patients With Chronic Low Back Pain
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 |
|---|---|---|
| Chronic Low Back Pain Foot Pronation | Device: Custom-made foot orthoses Versus a flat insole | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 110 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Effect Mechanism of Custom-made Foot Orthoses on Foot Pronation Subjects and Chronic Low Back Pain: a Randomized Controlled Trial |
| Actual Study Start Date : | January 15, 2019 |
| Actual Primary Completion Date : | June 1, 2019 |
| Estimated Study Completion Date : | July 15, 2019 |
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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Locations
| Spain | |
| Manuel Pabón Carrasco | Recruiting |
| Seville, Spain | |
| Contact: MANUEL PABÓN-CARRASCO 667284194 manuelpaboncarrasco@gmail.com | |
| Principal Investigator: Autora Castro-Méndez | |
Sponsors and Collaborators
University of Seville
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 9, 2019 | ||||||||
| First Posted Date ICMJE | June 25, 2019 | ||||||||
| Last Update Posted Date | June 25, 2019 | ||||||||
| Actual Study Start Date ICMJE | January 15, 2019 | ||||||||
| Actual Primary Completion Date | June 1, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect Mechanism of Custom-made Foot Orthoses in Patients With Chronic Low Back Pain | ||||||||
| Official Title ICMJE | Effect Mechanism of Custom-made Foot Orthoses on Foot Pronation Subjects and Chronic Low Back Pain: a Randomized Controlled Trial | ||||||||
| 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). | ||||||||
| 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 |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
|
||||||||
| Intervention ICMJE | 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)
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Unknown status | ||||||||
| Estimated Enrollment ICMJE |
110 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 15, 2019 | ||||||||
| Actual Primary Completion Date | June 1, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Listed Location Countries ICMJE | Spain | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03996980 | ||||||||
| Other Study ID Numbers ICMJE | CRESEUE-Foot | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | MANUEL PABON CARRASCO, University of Seville | ||||||||
| Study Sponsor ICMJE | University of Seville | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | University of Seville | ||||||||
| Verification Date | June 2019 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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