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

Not Applicable

Completed

Conditions: Foot Pronation
Chronic Low Back Pain

Registration Number: NCT03996980

Lead Sponsor: 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).

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 110

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index Questionnaire(ODI) for Lower Back Pain	Baseline	This questionnaire has been designed to give us information as to how your back or leg pain is affecting your ability to manage in everyday life.The test is considered the 'gold standard' of low back functional outcome tools 0% to 20%: minimal disability: The patient can cope with most living activities. 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.
VAS for Chronic Low Back Pain	Baseline	10 visual analogue scale (VAS).The findings suggested that 10 VAS ratings of no pain (0-2), mild pain(2-4), moderate pain (4-7), and severe pain (7-10)
Foot Posture Index	At the moment of inclusion in the study	Foot posture was assessed by a podiatrist during the biomechanical assessment based on the six-item foot posture index (FPI≥+6). The FPI consists of six validated items that are measured in a relaxed standing position of the subject. Each item is assessed on a -2 to +2 scale, where -2 indicates a supinated position, 0 indicates a neutral position and +2 indicates a pronated position, depending on the specific item. The sum of the scores of the six items provides a total score ranging from -12 to +12.

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index Questionnaire (ODI)	at the end of the study, approximately 4 weeks	Oswestry Disability Index Questionnaire (ODI) for chronic low back pain
VAS	At 4 weeks after baseline	VAS scale for CLBP Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity.

Trial Locations

Locations (2): university. Departament of Podiatry
🇪🇸
Seville, Spain
Manuel Pabón Carrasco
🇪🇸
Seville, Spain
university. Departament of Podiatry
🇪🇸Seville, Spain