No registrations found.
ID
Source
Brief title
Health condition
low back pain, injection, PRP, discogenic diseases
lage rugpijn, injectering, PRP, discogene pijn.
Sponsors and support
Intervention
Outcome measures
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.
Study objective
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.
Study design
Outcome will be measured post injection at 1 week, 4 weeks, 2 months, 6 months, 1 year.
Intervention
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.
[default]
The Netherlands
[default]
The Netherlands
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.
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4004 |
| NTR-old | NTR4176 |
| Other | : Rugpoli |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |