Back to resultsEffect Mechanism of Custom-made Foot Orthoses in Patients With Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain, Foot Pronation
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Custom-made foot orthoses Versus a flat insole
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Low back pain, custom-made foot orthoses, Foot, pronation, posture
Eligibility 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
Sites / Locations
- Manuel Pabón CarrascoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Custom-made foot orthoses
Placebo
Arm Description
treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks
a flat insole for a period of 4 weeks
Outcomes
Primary Outcome Measures
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.
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
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.
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.
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03996980
Brief Title
Effect Mechanism of Custom-made Foot Orthoses in Patients With Chronic Low Back Pain
Official Title
Effect Mechanism of Custom-made Foot Orthoses on Foot Pronation Subjects and Chronic Low Back Pain: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
July 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Foot Pronation
Keywords
Low back pain, custom-made foot orthoses, Foot, pronation, posture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Custom-made foot orthoses
Arm Type
Experimental
Arm Description
treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
a flat insole for a period of 4 weeks
Intervention Type
Device
Intervention Name(s)
Custom-made foot orthoses Versus a flat insole
Intervention Description
Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)
Primary Outcome Measure Information:
Title
Assess chronic low back pain
Description
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.
Time Frame
At the moment of inclusion in the study
Title
Assess chronic low back pain
Description
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
Time Frame
At the moment of inclusion in the study
Title
Assess the position of the foot
Description
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.
Time Frame
At the moment of inclusion in the study
Title
Assess chronic low back pain
Description
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.
Time Frame
After four weeks of use of the orthose treatment.
Title
Assess chronic low back pain
Description
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
Time Frame
After four weeks of use of the orthose treatment.
Title
Assess the position of the foot
Description
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.
Time Frame
After four weeks of use of the orthose treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Manuel Pabón Carrasco
City
Seville
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MANUEL PABÓN-CARRASCO
Phone
667284194
Email
manuelpaboncarrasco@gmail.com
First Name & Middle Initial & Last Name & Degree
Autora Castro-Méndez
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effect Mechanism of Custom-made Foot Orthoses in Patients With Chronic Low Back Pain
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