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

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ClinicalTrials.gov Identifier: NCT03996980
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
MANUEL PABON CARRASCO, University of Seville

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


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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

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


  4. 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.

  5. 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

  6. 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.




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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996980


Locations
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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

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Responsible Party: MANUEL PABON CARRASCO, Principal Investigator, University of Seville
ClinicalTrials.gov Identifier: NCT03996980     History of Changes
Other Study ID Numbers: CRESEUE-Foot
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MANUEL PABON CARRASCO, University of Seville:
Low back pain
custom-made foot orthoses
Foot
pronation
posture

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms