This aim of this study is to evaluate the secondary outcome measures including three to four year re-injury data.
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome return to play has been published previously.
Secondary outcome
Not previously reported secondary outcome scores include re-injury at three to
four year, alteration in clinical and MRI parameters, subjective patient
satisfaction and the hamstring-outcome score.
Background summary
Platelet-rich plasma (PRP) injections are used worldwide to treat acute muscle
injuries. We examined whether PRP injections would be efficacious in hamstring
injuries. The core methods and the primary outcome measure were published in
the New England Journal
of Medicine (NEJM) as *Platelet-Rich Plasma Injections in Acute Muscle Injury*.
This aim of this study is to evaluate the secondary outcome measures including
three to four year reinjury data.
Study objective
This aim of this study is to evaluate the secondary outcome measures including
three to four year re-injury data.
Study design
long term (3-4 years) follow-up of a randomized, double-blind,
placebocontrolled trial
Study burden and risks
Based on the current literature we expect no significant burden and risks
associated with participation and considered as negligible.
Burgemeester Banninglaan 1
Leidschendam 2262 BA
NL
Burgemeester Banninglaan 1
Leidschendam 2262 BA
NL
Listed location countries
Age
Inclusion criteria
Between February 2011 and November 2012 patients were included that fullfilled the following inclusion criteria:
1. Clinical diagnosis of an acute hamstring injury, defined as 12:
- anamnestic acute injury
- anamnestic pain in posterior thigh
- localised pain during palpation of hamstring muscle
- localised pain during passive straight leg raising
- increasing pain during isometric contraction
AND
2. Isolated hamstring lesion on MRI (increased signal of injured muscle on T2 and/or STIR)
AND
3. First injection will be performed maximal 5 days after injury
AND
4. Informed consent
AND
5. Age 18-50 years
Exclusion criteria
1. Patient is not capable of doing an active exercise program
2. Patient has received injection therapy for this injury before
3. Patient does not have the intention to return to full sports activity
4. Patient does not want to recieve one of the two therapies
5. Cause of hamstring injury is an extrinsic trauma on posterior thigh
6. Patient has chronic low back pain
7. There are contraindications for MRI: pacemaker, pregnancy, claustrofobia
8. Patient has chronic hamstring complaints, defined as 13: recurrent pain or tenderness
of hamstring muscle during at least 2 months
9. There is a grade 3 lesion (total rupture) and/or avulsion on MRI
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53115.098.15 |