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
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