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NCT Number: NCT03996980

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

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).

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Key information

Conditions

Chronic Low Back Pain Back Pain Foot Pronation Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manuel Pabón Carrasco, Seville, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Custom-made foot orthoses Versus a flat insole

Device

Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)

Primary outcomes

  1. Oswestry Disability Index Questionnaire(ODI) for Lower Back Pain

    Time frame: 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.

  2. VAS for Chronic Low Back Pain

    Time frame: 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)

  3. Foot Posture Index

    Time frame: 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 outcomes

  1. Oswestry Disability Index Questionnaire (ODI)

    Time frame: at the end of the study, approximately 4 weeks

    Oswestry Disability Index Questionnaire (ODI) for chronic low back pain

  2. VAS

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2019
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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