|- candidate number||15422|
|- NTR Number||NTR4176|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-sep-2013|
|- Secondary IDs||Rugpoli |
|- Public Title||Studying the effectivity of injecting platelet rich plasma in painful disci, a randomised controlled trial study.|
|- Scientific Title||The effectivity of injecting PRP in painful disci, a randomised controlled trial study.|
|- ACRONYM||PRP in disci|
|- hypothesis||An 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) studied||Low back pain (LBP), Injection, PRP, Discogenic diseases|
|- Inclusion criteria||The 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 criteria||Modic|
Patients unable, according to protocol, to stop taking anticoagulantia.
systemic infection or skin infectin over the puncture site
Allergy to contrast
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 received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2014|
|- planned closingdate||1-jan-2016|
|- Target number of participants||96|
|- Interventions||The 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 outcome||The 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 outcome||Secondary outcomes include observation for any untoward side-effects including increased pain, bleeding, infection and motor or sensory deficits. |
|- Timepoints||Outcome will be measured post injection at 1 week, 4 weeks, 2 months, 6 months, 1 year.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| |
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator ||Stichting rugpoli|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||16-sep-2013 - 6-nov-2013|