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Foot Orthoses in Patients with Sciatica

NCT05129540 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-12-09

No results posted yet for this study

Summary

Chronic sciatica is a frequent problem whose symptoms could be related to the abnormal stresses applied to the musculoskeletal system during the gait cycle due to foot alterations.

The objectives of this study are to describe the main foot alterations in patients with chronic sciatica, and to evaluate whether foot orthoses can help alleviate this pain. Patients with chronic sciatica caused by lumbar disc herniation will be recruited and randomly allocate to one of both groups: one group that will be treated with custom-made foot orthoses, and one group that will be treated with a placebo orthotic device. Quality of life, pain in low-back, lower limb and foot, and disability caused by foot pain will be recorded at baseline, and after a two-month follow-up period.

Conditions

  • Chronic Sciatica
  • Foot Deformity

Interventions

DEVICE

Custom-made foot orthosis

The foot orthoses for group A will be custom made using phenolic foam molds of the feet. They consist of a polypropylene layer of 3 mm from heel to just proximal to the metatarsal heads, and an upper sheet of 30 Shore A polyethylene foam.

DEVICE

Placebo orthosis

A flat insole made of the same material as the upper layer of the custom-made foot orthoses used for group "custom-made foot orthosis".

Sponsors & Collaborators

  • University of Seville

    lead OTHER

Principal Investigators

  • Pedro V Munuera-Martínez, Ph.D · University of Seville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-17
Primary Completion
2023-05-15
Completion
2024-11-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05129540 on ClinicalTrials.gov