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Autologous conditioned plasma injection for acute hamstring muscle injury.

Autologous conditioned plasma injection for acute hamstring muscle injury. - Dutch Hamstring Injection Therapy (HIT) study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37939
Enrollment
80
Registered
2011-02-11
Start date
2011-02-17
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hamstring rupture hamstring strain

Interventions

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 gr

Sponsors

Arthrex Medizinische Instrumente GmbH
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Time to return to full sports activity; both training or match play.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)