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.
ID
Bron
Verkorte titel
Aandoening
low back pain, injection, PRP, discogenic diseases
lage rugpijn, injectering, PRP, discogene pijn.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is improvement in pain and function following platelet rich plasma injection. <br>
The outcome will be measured by means of Numeric pain scale, Short form health Survey (SF-36), Roland Morris disability questionnaire.
Doel van het onderzoek
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.
Onderzoeksopzet
Outcome will be measured post injection at 1 week, 4 weeks, 2 months, 6 months, 1 year.
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
[default]
The Netherlands
Wetenschappers
[default]
The Netherlands
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Modic
Patients unable, according to protocol, to stop taking anticoagulantia.
Pregnancy.
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4004 |
| NTR-old | NTR4176 |
| Ander register | : Rugpoli |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |