Enhancing muscle healing using platelet-rich plasma (PRP) injection
| ISRCTN | ISRCTN66528592 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66528592 |
| Secondary identifying numbers | 835.11 |
- Submission date
- 16/08/2011
- Registration date
- 25/08/2011
- Last edited
- 15/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Muscle strains are one of the most common injuries affecting athletes. Most muscle injuries are caused by contusion (bruising) or excessive strain of the muscle, especially in sports that require sprinting or jumping activities. The best treatment for muscle strains is still not known. Various treatments are being used with limited evidence. Current approaches include rest, ice, compression and elevation (RICE) together with a short period of immobilization during the early stage after injury. Despite these, the time to full recovery is still lengthy (between 6 weeks to never). The median time to full return to play in Malaysian athletes was 45 days. Within the last 5 years, there has been a growing interest in the use of platelet-rich plasma (PRP) for muscle injuries. Several reports have suggested that PRP may accelerate muscle healing and allow earlier return to play. The main aim of this study is to determine the effectiveness of a single injection of platelet-rich plasma (PRP) for the treatment of muscle injury.
Who can participate?
Patients aged 18 and over who have been diagnosed with a muscle injury within the last 5 days
What does the study involve?
After giving your written consent to participate in the study you will be asked to fill in a set of questionnaires about yourself and your injury. An ultrasound examination will be conducted to confirm your injury. Participants diagnosed with grade 2 muscle injury will be randomly divided into two groups. Participants in both groups will need to follow a standard muscle injury rehabilitation program under the supervision of a sports physiotherapist at the Sports Clinic, University Malaya Medical Centre. In addition, 50 ml of blood will be withdrawn from patients in Group 2. The blood will be processed to obtain platelet-rich plasma (PRP). The PRP obtained will be injected under ultrasound guidance into the injured muscle. A small amount of local anaesthetic will be given prior to PRP injection. Participants are allowed to take paracetamol when necessary. Participants from both groups will be monitored on a weekly basis until full recovery or the end of week 16.
What are the possible benefits and risk of participating?
You may recover from the injury faster, and since the PRP is extracted from your own blood and the injection is done using a clean technique we do not anticipate any major risk for any of the participants in this study. Participants may experience some pain during PRP injection or during the blood taking process.
Where is the study run from?
The Sports Medicine Clinic, University Malaya Medical Centre, organizes the study.
Two outpatient clinics are involved: the Sport Medicine Clinic at the University Malaya Medical Centre, and the Sports Clinic at the National Institute of Sports of Malaysia.
When is the study starting and how long is it expected to run for?
The study will be open to participants from November 2011 until January 2013.
Who is funding the study?
University of Malaya (Malaysia).
Who is the main contact?
Dr Mohamad Shariff A Hamid
ayip@um.edu.my
Contact information
Scientific
Unit of Sports Medicine
Faculty of Medicine
University of Malaya
Kuala Lumpur
50603
Malaysia
| Phone | +60 (0)3 7967 4968 |
|---|---|
| ayip@um.edu.my |
Study information
| Study design | Randomised single-blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Platelet-rich plasma (PRP) injection for the treatment of grade 2 muscle injury: a randomised single-blinded clinical trial |
| Study acronym | PRP- RTP |
| Study objectives | 1. There is a significant difference in the recovery time following acute muscle injury in patients receiving platelet-rich plasma (PRP) injection therapy compared with patient receiving rehabilitation therapy only. 2. The PRP intervention group will demonstrate a faster duration to return-to-play (RTP) than the control group. |
| Ethics approval(s) | Medical Ethics Committee, University Malaya Medical Centre, 25/02/2011, MEC Ref. No: 835.11 |
| Health condition(s) or problem(s) studied | Muscle injury |
| Intervention | Eligible injured athletes were randomised using computer block randomisation software into two groups: 1. Control group (C) 2. PRP group (PRP) Control group Participants in the control group will receive a standard physiotherapy treatment (attended by a trained sports physiotherapist). This consists of the use of cryotherapy, range of motion (ROM) and muscle strengthening exercises. In addition the use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed throughout the study. The use of oral paracetamol however is allowed. PRP group In addition to the standard physiotherapy treatment participants in this group will receive a single PRP (3 mls) injection into the site of injury. The PRP will be extracted from participants own blood. The use of non-steroidal anti-inflammatory (NSAIDs) will not be allowed throughout the study. The use of oral paracetamol however is allowed. |
| Intervention type | Other |
| Primary outcome measure | 1. Duration to full recovery (return-to-play) Criteria for RTP: 1.1. Muscle strength: at or near pre-injury levels or symmetrical with unaffected site 1.2. Range of motion: at or near pre-injury levels or symmetrical with unaffected site 1.3. Tenderness: injury site should be non-tender 1.4. Inflammation or swelling: no swelling or inflammation Outcomes are measured on a weekly basis until full recovery of the end of week 16 |
| Secondary outcome measures | 1. Level of platelets - blood and PRP 2. Level of growth factors in PRP 2.1. Insulin-like growth factor (IGF-1) 2.2. Transforming growth factor (TGF)-beta 2.3. Basic fibroblast growth factor (FGF) 2.4. Platelet-derived growth factor (PDGF) 3. Isokinetic muscle strength 4. Brief pain inventory - Short form (BPI-SF) Outcomes are measured on a weekly basis until full recovery of the end of week 16 |
| Overall study start date | 01/11/2011 |
| Completion date | 01/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. 18 years old and above 2. Acute muscle injury (less than 1 week) 3. Able to understand study protocol and informed consent |
| Key exclusion criteria | 1. Received any form of injection therapy 2. Using non-steroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to randomisation 3. Unable to fulfill follow-up schedule 4. Significant cardiovascular, renal, hepatic disease, malignancy, history of anemia or previous muscle surgery |
| Date of first enrolment | 01/11/2011 |
| Date of final enrolment | 01/01/2013 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
50603
Malaysia
Sponsor information
Hospital/treatment centre
Unit of Sports Medicine
Faculty of Medicine
University of Malaya
Kuala Lumpur
50603
Malaysia
| Phone | +60 (0)3 7967 4968 |
|---|---|
| ayip@um.edu.my | |
| Website | http://www.ummc.um.edu.my |
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/08/2012 | Yes | No |
