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

Fundación Garcia Cugat

Status: Completed

Conditions: Stress Fracture Metatarsal

Treatments: Procedure: Intramedullary screw fixation; Device: Focused Shock Wave Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04120662

REHA-2019-02

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Group A: Surgery group

Active Comparator group

Description:

Surgical procedure according to the injury type

Treatment:

Procedure: Intramedullary screw fixation

Goup B: Shockwave group

Active Comparator group

Description:

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

Treatment:

Device: Focused Shock Wave Treatment