Effectiveness of Shockwave Treatment for Proximal Fifth Metatarsal Stress Fracture in Soccer Players

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2019-10-15

Brief Summary

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Fifth metatarsal stress fracture is a failure of a healthy metatarsal bone subject to repetitive microdamages. It has a high prevalence in soccer players and is classified as a high-risk stress fracture. Based on Torg classification, the treatment options may be conservative or surgical. The recent increase of evidences about Shock Wave Treatment in different bone pathologies, including stress fractures, suggests the possibility to use this conservative intervention option also in patients candidate for surgery. This randomized clinical trial included 18 soccer players diagnosed of proximal fifth metatarsal stress fracture, randomly matched in Surgery group and Shock Wave group. Patients of Surgery group were treated with intramedullary screw fixation; patients of Shock Wave group received 3 weekly sessions of Focused Shock Wave Treatment (F-ESWT), using an electrohydraulic device set to an energy flux density (EFD) of 0.21 mJ/mm2 and 2000 impulses. Patients of both groups were followed monthly until their return to play (RTP) using radiography, Visual Analogue Scale (VAS), Tegner Activity Level Scale and AOFAS score.

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Detailed Description

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Conditions

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Stress Fracture Metatarsal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A: Surgery group

Surgical procedure according to the injury type

Group Type ACTIVE_COMPARATOR

Intramedullary screw fixation

Intervention Type PROCEDURE

A Kirschner wire was introduced in the proximal tuberosity under anteroposterior and lateral fluoroscopic control, following the bone axis and passing through the fracture line; a cannulated compressor screw in a diameter between 45 - 55 mm in the more satisfactory position to achieve the optimal fragments compression.

Goup B: Shockwave group

3 weekly sessions of Focused Shock Wave Treatment (F-ESWT), using an electrohydraulic device set to an energy flux density (EFD) of 0.21 mJ/mm2 and 2000 impulses

Group Type ACTIVE_COMPARATOR

Focused Shock Wave Treatment

Intervention Type DEVICE

3 weekly session, one per week, of focused shock waves, using an electrohydraulic device.

Interventions

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Intramedullary screw fixation

A Kirschner wire was introduced in the proximal tuberosity under anteroposterior and lateral fluoroscopic control, following the bone axis and passing through the fracture line; a cannulated compressor screw in a diameter between 45 - 55 mm in the more satisfactory position to achieve the optimal fragments compression.

Intervention Type PROCEDURE

Focused Shock Wave Treatment

3 weekly session, one per week, of focused shock waves, using an electrohydraulic device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male soccer players, aged over 18 years.
* Diagnosis of proximal fifth metatarsal stress fracture, according to clinical signs and symptoms and to radiologic findings
* Fracture occurred during soccer practice
* Informed consent signed

Exclusion Criteria

* To be under 18 years old
* Traumatic fracture
* Fracture occurred out of soccer practice
* Patients with metatarsal shaft, neck or head fracture
* Patients with contraindication to receive surgical treatment
* Patients with contraindication to receive shock wave treatment
* Patients that refuse the informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No