Condition category
Injury, Occupational Diseases, Poisoning
Date applied
16/07/2009
Date assigned
27/08/2009
Last edited
18/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Lee

ORCID ID

Contact details

Cardiff University
Medical Engineering
Queen's Buildings
The Parade
Cardiff
CF24 3AA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0.5

Study information

Scientific title

A pilot study on intramuscular injection therapy of Actovegin® in elite football players with muscular injuries

Acronym

ActoFC

Study hypothesis

Actovegin® injection therapy can reduce number of days from muscle injury for the player to return to training with the first team.

Ethics approval

Cardiff University Ethics Board with independent review approved on the 02/07/2009. NHS Ethics and MHRA approval pending as of 17/07/2009.

Study design

Randomised double-blinded single-centre interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Grade 1 and Grade 2 muscle injury

Intervention

3 x intra-muscular injection of normal saline or Actovegin® with Traumeel® directly to the injury site, 1 ml injected 1 cm above the injury site and 1 ml injected to 1 cm below the injury site.

Duration of treatment will be 1 week, duration of follow up will be determined by recovery time and when they are back playing with the first team.

Intervention type

Drug

Phase

Not Applicable

Drug names

Actovegin®

Primary outcome measures

Number of days from injury for the player to return to training with the first team

Secondary outcome measures

1. Player's perception of pain and effectiveness of treatment
2. Player's isokinetic and isometric data

Overall trial start date

01/03/2010

Overall trial end date

31/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Informed consent
2. Aged greater than 18 years, male only
3. Clinical and magnetic resonance imaging (MRI) diagnosis of muscle injuries
4. Grade 1 or 2 muscle tear
5. No previous allergic reaction to Actovegin®

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

All first team players in the club (25)

Participant exclusion criteria

1. Grade 3 or more muscle injuries
2. Fractures
3. Other soft tissue injuries besides muscle tears

Recruitment start date

01/03/2010

Recruitment end date

31/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiff University
Cardiff
CF24 3AA
United Kingdom

Sponsor information

Organisation

Cardiff University (UK) - Medical Engineering

Sponsor details

Cardiff School of Engineering
Queen's Buildings
The Parade
Cardiff
CF24 3AA
United Kingdom

Sponsor type

University/education

Website

http://www.cardiff.ac.uk/

Funders

Funder type

University/education

Funder name

Cardiff University (UK) - Medical Engineering

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cardiff City Football Club (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes