|- candidate number||9144|
|- NTR Number||NTR2771|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-feb-2011|
|- Secondary IDs||NL34660.098.10 / 10-163; ABR / METC Zuidwest Holland|
|- Public Title||Dutch Hamstring Injection Therapy study.|
|- Scientific Title||Autologous Conditioned Plasma injections for acute hamstring injuries.|
|- ACRONYM||Dutch HIT study|
|- hypothesis||The time to return to sport is shorter in the patient group treated with Autologous Conditioned Plasma (ACP) injections in combination with exercise therapy in comparison with the patient group treated with saline injections in combination with exercise therapy.|
|- Healt Condition(s) or Problem(s) studied||Acute hamstring injury, Growth factors, Autologous Conditioned Plasma (ACP)|
|- Inclusion criteria||1. Clinical diagnosis of an acute hamstring injury, defined as:|
A. Anamnestic acute injury;
B. Anamnestic pain in posterior thigh;
C. Localised pain during palpation of hamstring muscle;
D. Localised pain during passive straight leg raising;
E. Increasing pain during isometric contraction.
2. Isolated hamstring lesion on MRI (increased signal of injured muscle on T2 and/or STIR);
3. First injection will be performed maximal 5 days after injury;
4. Informed consent;
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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||24-feb-2011|
|- planned closingdate||24-feb-2013|
|- Target number of participants||80|
|- Interventions||In this double-blind randomised controlled trial two patient groups are compared:|
1. Intervention group: ACP injections (3 ml in depots of 1 ml) in combination with exercise therapy;
2. Control group: Saline injections in combination with exercise therapy.
Two injections will be given with 5-7 days in between.
|- Primary outcome||Time to return to full sports activity; either training or match play.|
|- Secondary outcome||1. Recovery assessed with a sevenpoints Likert scale;|
2. Hamstring force, measured with dynamic hand hold meter;
3. Recurrent hamstring lesions;
4. Maximal and mean pain score in rest and during sprinting assessed with the visual analogue scale (VAS);
5. Pain with isometric contraction against resistance assessed with the visual analogue scale (VAS);
6. Length of pain area during palpation;
7. Clinical hamstring tests:
A. Passive straight leg raising;
B. Active knee extension;
C. Active slump test;
D. Taking shoe out sign.
8. Clinical sacroiliacal tests:
A. Stork test;
B. Multi test regime;
C. Gillet test.
9. Hip- and knee range of motion;
10. Functional outcome score (Tegner acivity score, hamstring outcome score);
11. Subjective patient satisfaction: The patient satisfaction will be determined by the patient to ask how satisfied they are with the effect of the treatment in 4 possible categories: excellent / good / moderate / poor. The groups "excellent" and "good" will be regarded as successful and the groups of "moderate" and "poor" as not successful;
12. Prediction of patient and sports physician for time to return to sports;
13. Prediction of the patient of the used intervention (ACP or placebo);
14. Platelet count in whole blood and ACP;
15. Recovery hamstring lesion on MRI at return to sport.
Hamstring muscle injuries on MRI will be classified according to the three graded classification of Hancock (2009):
1. Grade I: Oedema without architectural distortion (indicating a microtear);
2. Grade II: Partial tear;
3. Grade III: A complete tear (excluded in this study).
This (widely used) classification system will be used for analysis of possible differences at baseline and during the final analysis.
|- Timepoints||Follow-up will be performed after 1, 3, 4, 8, 10, 16, 26, 52 weeks and at return to sports.|
Follow-up after 3, 4, 8, 10, 16 and 52 weeks will be performed by phone and will not consist a physical examination.
|- Trial web site||www.hamstringonderzoek.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| J.L. Tol|
|- CONTACT for SCIENTIFIC QUERIES|| G. Reurink|
|- Sponsor/Initiator ||The Hague Medical Centre Antoniushove, University Medical Center Utrecht (UMCU), KNVB Sportmedisch Centrum|
(Source(s) of Monetary or Material Support)
|Arthrex Medizinische Instrumente GmbH|
|- Brief 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 shown 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 deliberately 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 a non-randomized control group.
In this study two treatment groups will be compared: ACP injection in combination with exercise therapy and placebo injection in combination with exercise therapy.
Multi centre, double blind, randomized controlled trial comparing two treatment groups.
80 patients with an acute hamstring lesion with MRI abnormalities.
Both the intervention group as the control group will perform exercise therapy. The intervention group is treated with ACP injection at maximal 5 days after the injury and the control group will receive placebo injection at the same time interval. A second injection is provided 5-7 days after the first injection. Injections are performed ultrasound guided in the lesion of the hamstring muscle.
Primary: Time to return to full sports activity; either training or match play.
Secondary: Rate of recovery, hamstring force, recurrent hamstring lesions, pain score in rest, during sprinting and during isometric contraction assessed with the visual analogue scale (VAS), length of pain area during palpation, clinical hamstring- and sacroiliacal tests, hip- and knee range of motion, functional outcome, subjective patient satisfaction, prediction of patient and sports physician for time to return to sports, rediction of the patient of the used intervention (ACP or placebo),platelet count in whole blood and ACP, recovery hamstring lesion on MRI.
Follow-up will be performed after 1, 3, 4, 8, 10, 16, 26, 52 weeks and at return to sports.
|- Main changes (audit trail)||2-2-14: The variables 12 (prediction of patient and sports physician for time to return to sports) and 13 (prediction of the patient of the used intervention) in the secondary outcome measures are removed from the protocol. These variables were actually baseline measures and no outcome measures. |
|- RECORD||21-feb-2011 - 2-feb-2014|