Foot Orthoses in Patients with Sciatica

NCT05129540 | Terminated

• 1 other identifier: SCIATICA AND FOOT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Rate of Lumbar pain

  Rate of pain perceived in the lumbar region. Visual analogue scale will be used to record pain at baseline and at the end of the follow-up period, and self-reported pain intensity once a month by phone call will be assessed with an 11-point NPRS with 0 = no pain to 10 = pain as bad as it can be.

  3 months

• Rate of ower limb pain

  Rate of pain perceived in the posterior surface of the lower extremity. Visual analogue scale will be used to record pain at baseline and at the end of the follow-up period, and self-reported pain intensity once a month by phone call will be assessed with an 11-point NPRS with 0 = no pain to 10 = pain as bad as it can be.

  3 months

• Rate of foot pain

  Rate of pain perceived in the foot and ankle region. Visual analogue scale will be used to record pain at baseline and at the end of the follow-up period, and self-reported pain intensity once a month by phone call will be assessed with an 11-point NPRS with 0 = no pain to 10 = pain as bad as it can be.

  3 months

Secondary Outcomes (2)

• Rate of Quality of life

  3 months

• Rate of disability related to the foot

  3 months

Study Arms (2)

Custom-made foot orthoses group

EXPERIMENTAL

Custom-made foot orthoses will be applied to participants in this arm. The orthoses will consist on a 3-mm thick polypropylene layer from heel to just proximal to the metatarsal heads, and a cover layer of polyethylene foam from heel to toe tips. Both materials will be adapted to the foot positive casts that will be obtained from all participants.

Device: Custom-made foot orthosis

Placebo group

PLACEBO COMPARATOR

The placebo orthoses will consist on a 3-mm thick polyethylene foam layer from heel to toe tips and a 0.8-mm thick resin layer from heel to just proximal to the metatarsal heads. None of the materials will be adapted to the foot positive casts.

Device: Placebo orthosis

Interventions

Custom-made foot orthosis DEVICE

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.

Also known as: Foot orthotics, Insole

Custom-made foot orthoses group

Placebo orthosis DEVICE

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".

Placebo group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having lumbar and/or lower extremity pain.
• Having a medical diagnosis of chronic sciatica caused by lumbar disc herniation.

You may not qualify if:

• Ulcers within the foot.
• Diabetes mellitus.
• Pregnancy.
• Cognitive deterioration.
• Previous osteoarticular foot surgery.
• Concomitant inflammatory rheumatic disease.
• Need for walking assistance.
• Being treated with foot orthotics.
• Refuse to use appropriated and health footwear (with no more than a 3 cm drop, wide and spacious with removable, laced or velcro insole, posterior buttress, medial-lateral stability, and flexibility in metatarsophalangeal area to allow dorsiflexion).

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Department of Podiatry

Seville, 41009, Spain

Location

Related Publications (27)

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  BACKGROUND

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MeSH Terms

Conditions

Foot Deformities

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Pedro V Munuera-Martínez, Ph.D

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Custom-made foot orthoses and placebo orthoses will have similar appearance for participants. The investigator who record data by means of questionnaires will not know which group the patients belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Two groups of people with chronic sciatica caused by lumbar disc herniation will be included. Patients in group A will be given treatment with custom-made foot orthoses. Patients in group B will be given treatment with placebo orthoses.

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 22, 2021
• Study Start: November 17, 2022
• Primary Completion: May 15, 2023
• Study Completion: November 1, 2024
• Last Updated: December 9, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)