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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03996980
• Other study ID #: CRESEUE-Foot
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: July 15, 2019

Study information

• Verified date: June 2019
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 15, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Foot Pronation
• Low Back Pain

Intervention

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)

Locations

Country	Name	City	State
Spain	Manuel Pabón Carrasco	Seville

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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.