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

Stress Fracture Metatarsal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120662
• Other study ID #: REHA-2019-02
• Status: Completed
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: July 2021
• Source: Fundación Garcia Cugat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 15, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Stress
• Stress Fracture Metatarsal

Intervention

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.

Device:
• Focused Shock Wave Treatment
3 weekly session, one per week, of focused shock waves, using an electrohydraulic device.

Locations

Country	Name	City	State
Spain	Fundacion Garcia Cugat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Garcia Cugat

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of X-Ray	X-Ray study	Follow up until recovery (maximum of 6 months)
Primary	Period until return to play	When the patient can start the previous to injury activity	Follow up until recovery (maximum of 6 months)
Secondary	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)
Secondary	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)
Secondary	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)