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van CCT (UK)

van CCT (UK)

Studying the effectivity of injecting platelet rich plasma in painful disci, a randomised controlled trial study.

- candidate number15422
- NTR NumberNTR4176
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-sep-2013
- Secondary IDsRugpoli 
- Public TitleStudying the effectivity of injecting platelet rich plasma in painful disci, a randomised controlled trial study.
- Scientific TitleThe effectivity of injecting PRP in painful disci, a randomised controlled trial study.
- ACRONYMPRP in disci
- hypothesisAn injection of 1cc PRP, taken and processed directly from the patient, in a lumbal disc with or without anular tear, without modic, significantly improves pain and functionality.
- Healt Condition(s) or Problem(s) studiedLow back pain (LBP), Injection, PRP, Discogenic diseases
- Inclusion criteriaThe patients are aged between 18 en 65 jaar.
Pain persists for an extended period of time (ie >3 months]
pain is not responsive to conservative treatment (oral medicatin, rehabilitation). Maintained intervertbral disc heigths of at least 50% and protrusion less than 5mm on MRI.
Positive result on the discografie in conformity with Isis Guidelines.
The exclusion criteria are not applicable.
- Exclusion criteriaModic
Patients unable, according to protocol, to stop taking anticoagulantia.
systemic infection or skin infectin over the puncture site
Allergy to contrast
Psychiatric conditions
Solid bonefusion that does not allow access to the disc Severe intervertebral disc protrusions lager than 5mm, extrusions, or sequestered fragment
Severe spinal canal compromise at the disc levels to be investigated
Spondylolisthesis level 2 or higher.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate1-jan-2016
- Target number of participants96
- InterventionsThe intervention to be studied is the intradiscal delivery of Platelet Rich Plasma for proposed symptomatic improvement in pain and function related to treatment of annular tears at the appropriate disc level, as determined by discography.
- Primary outcomeThe primary outcome is improvement in pain and function following platelet rich plasma injection.
The outcome will be measured by means of Numeric pain scale, Short form health Survey (SF-36), Roland Morris disability questionnaire.
- Secondary outcomeSecondary outcomes include observation for any untoward side-effects including increased pain, bleeding, infection and motor or sensory deficits.
- TimepointsOutcome will be measured post injection at 1 week, 4 weeks, 2 months, 6 months, 1 year.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Stichting rugpoli
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- PublicationsN/A
- Brief summary
- Main changes (audit trail)
- RECORD16-sep-2013 - 6-nov-2013

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