Injection therapy to muscle injuries in professional football players
| ISRCTN | ISRCTN78125864 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78125864 |
| Protocol serial number | 1.0.5 |
| Sponsor | Cardiff University (UK) - Medical Engineering |
| Funders | Cardiff University (UK) - Medical Engineering, Cardiff City Football Club (UK) |
- Submission date
- 16/07/2009
- Registration date
- 27/08/2009
- Last edited
- 17/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paul Lee
Scientific
Scientific
Cardiff University
Medical Engineering
Queen's Buildings
The Parade
Cardiff
CF24 3AA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blinded single-centre interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A pilot study on intramuscular injection therapy of Actovegin® in elite football players with muscular injuries |
| Study acronym | ActoFC |
| Study objectives | Actovegin® injection therapy can reduce number of days from muscle injury for the player to return to training with the first team. |
| Ethics approval(s) | Cardiff University Ethics Board with independent review approved on the 02/07/2009. NHS Ethics and MHRA approval pending as of 17/07/2009. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Actovegin® |
| Primary outcome measure(s) |
Number of days from injury for the player to return to training with the first team |
| Key secondary outcome measure(s) |
1. Player's perception of pain and effectiveness of treatment |
| Completion date | 31/07/2012 |
| Reason abandoned (if study stopped) | Not started |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 25 |
| Key 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® |
| Key exclusion criteria | 1. Grade 3 or more muscle injuries 2. Fractures 3. Other soft tissue injuries besides muscle tears |
| Date of first enrolment | 01/03/2010 |
| Date of final enrolment | 31/07/2012 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Cardiff University
Cardiff
CF24 3AA
United Kingdom
CF24 3AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/04/2025: The study was stopped (never started).
10/08/2017: No publications found in PubMed, verifying study status with principal investigator.
