In this study two treatment groups will be compared: ACP injection in combination with exercise therapy and placebo injection in combination with exercise therapy.
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time to return to full sports activity; both training or match play.
Secondary outcome
Recovery assessed with a sevenpoints Likert scale, hamstring force, recurrent
hamstring lesions, maximal and mean pain score in rest and during sprinting
assessed with the visual analogue scale (VAS), pain with isometric contraction
against resistance, length of pain area during palpation, clinical hamstring
tests (passive straight leg raising, active knee extension, active slump test,
taking shoe out sign), clinical sacroiliacal test (Stork test, multi test
regime score, Gillet test), hip- and knee range of motion, functional outcome
scores, subjective patient satisfaction, recovery of hamstringlesion on MRI
(with reservation of financing), prediction of patient and sports physician for
time to return to sports and prediction of the patient of the used intervention
(ACP or placebo). Follow-up will be performed after 1, 3, 4, 6, 8, 10, 16, 26
and 52 weeks.
Background summary
Muscle injuries account for up to 30% of injuries sustained in a sports event.
In soccer, muscle injuries mostly occur in the calf and thigh. When injured,
usually the RICE principle (rest, ice, compression, elevation) is practised,
NSAID's are supplied and exercise therapy is given. However, there is little
scientific evidence for the effectiveness of therapeutic interventions in
muscle injuries.
In the last decade research has focussed on developing new treatment options
for muscle injuries, including the use of growth factors. Research has showed
that myoblasts can be proliferated by growth factors. Growth factors are
present in autologous conditioned plasma (ACP). Injection of ACP has shown to
increase regeneration in deliberatly injured muscle in animals.
Only two studies examined the effect of ACP in human muscle injuries in
relatively small heterogenous group of patients. Both studies showed that
patients treated with ACP injections recovered faster from injury than patients
in the control group.
Study objective
In this study two treatment groups will be compared: ACP injection in
combination with exercise therapy and placebo injection in combination with
exercise therapy.
Study design
Double blind, randomized controlled trial comparing two treatment groups.
Intervention
Both the intervention group as the control group will have exercise therapy
with a fysiotherapist. The intervention group is treated with ACP injection
maximal 5 days after injury and the control group will recieve placebo
injection maximal 5 days after injury (randomized and double blind). A second
injection is performed 5-7 days after the first injection. Injections are
performed ultrasound guided in the lesion of the hamstring muscle.
Study burden and risks
The intramuscular injections can be painfull, but usually less painfull than
injections in tendons. A hematoma can occur. In previous studies with
comparable therapeutic interventions complications has never been described and
worsening of the muscle lesion is not reported. However, it is not possible to
say with certainty that these results also account for injection in the
hamstring.
After inclusion during one year there are 9 follow-up moments: three on the
policlinic (about 1 hour) and six by phone (about 20 minutes).
Carl-Zeiss-Str. 8
Garching 85748
DE
Carl-Zeiss-Str. 8
Garching 85748
DE
Listed location countries
Age
Inclusion criteria
1.Clinical diagnosis of an acute hamstring injury, defined as:
- 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.Hamstring lesion proven on MRI (increased signal in 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 year
Exclusion criteria
1.Patient is not capable of doing an active exercise program
2.Patient has recieved 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 chronich hamstring complaints (> 2 months)
9.There is a grade 3 lesion (total rupture) on MRI
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL34660.098.10 |
| OMON | NL-OMON23513 |