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

• Sponsor: Fundación Garcia Cugat (Other)
• Overall Status: Completed
• CT.gov ID: NCT04120662
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.6
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stress Fracture Metatarsal	Procedure: Intramedullary screw fixation; Device: Focused Shock Wave Treatment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Shockwave Treatment for Proximal Fifth Metatarsal Stress Fracture in Soccer Players
• Actual Study Start Date: Feb 26, 2019
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Oct 15, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Evaluation of X-Ray [Follow up until recovery (maximum of 6 months)]

   X-Ray study

2. Period until return to play [Follow up until recovery (maximum of 6 months)]

   When the patient can start the previous to injury activity

Secondary Outcome Measures

1. Evaluation of Visual Analogue Scale [Follow up until recovery (maximum of 6 months)]

   Subjective evaluation of the pain intensity from 0 (non-existent paint) to 10 (maximum pain feeling)

2. American Orthopedic Foot and Ankle Score [Follow up until recovery (maximum of 6 months)]

   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.

3. Evaluation of Tegner activity scale [Follow up until recovery (maximum of 6 months)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundacion Garcia Cugat	Barcelona		Spain	08023

Sponsors and Collaborators

• Fundación Garcia Cugat

Investigators

• Study Chair: Montse Garcia, Fundación Garcia Cugat

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fundación Garcia Cugat
• ClinicalTrials.gov Identifier: NCT04120662
• Other Study ID Numbers: REHA-2019-02
• First Posted: Oct 9, 2019
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fractures, Bone; Fractures, Stress

Study Results

No Results Posted as of Jul 21, 2021