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

The effectivity of injecting PRP in painful disci, a randomised controlled trial study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26177
Enrollment
96
Registered
2013-09-16
Start date
2014-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

low back pain, injection, PRP, discogenic diseases lage rugpijn, injectering, PRP, discogene pijn.

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 di

Sponsors

Stichting Rugpoli
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary outcomes include observation for any untoward side-effects including increased pain, bleeding, infection and motor or sensory deficits.

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)