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

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.

Study Overview

• Status: Completed
• Conditions: Stress Fracture Metatarsal
• Intervention / Treatment: Procedure: Intramedullary screw fixation; Device: Focused Shock Wave Treatment

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08023
    • Fundacion Garcia Cugat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: Surgery group; Surgical procedure according to the injury type	Procedure: 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.
Active Comparator: 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	Device: Focused Shock Wave Treatment; 3 weekly session, one per week, of focused shock waves, using an electrohydraulic device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of X-Ray	X-Ray study	Follow up until recovery (maximum of 6 months)
Period until return to play	When the patient can start the previous to injury activity	Follow up until recovery (maximum of 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Visual Analogue Scale	Subjective evaluation of the pain intensity from 0 (non-existent paint) to 10 (maximum pain feeling)	Follow up until recovery (maximum of 6 months)
American Orthopedic Foot and Ankle Score	Measures the results of the treatment for complex foot and ankle injuries that combines a patient informed and a specialist informed report. Scores range from 0 to 100, with a healthy midfoot receiving 100 point.	Follow up until recovery (maximum of 6 months)
Evaluation of Tegner activity scale	Tegner activity scale grades the daily life activities and recreational and professional sports practice. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports >6 score can only be achieved if the person participates in recreational or competitive sport.	Follow up until recovery (maximum of 6 months)

Collaborators and Investigators

• Sponsor: Fundación Garcia Cugat

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2019
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Stress
• Other Study ID Numbers: REHA-2019-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No