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PRP injections in disci

PRP injections in disci - PRP in disci

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44855
Enrollment
96
Registered
2014-03-26
Start date
2014-07-15
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

discogene lage rugklachten discus degeneration low back pain

Interventions

None listed

Sponsors

Stichting Rugpoli
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: discogenic low back problems o Aged between 18-65 o Pain exists for a minimum period of 3 months VAS score min. 5. o Pain does not respond to conservative treatment. o Remaining discushight 50% minimum controlled by MRI- of CT scan. o Extrusions of discus are 5 mm or less controlled by MRI- of CT scan. o Positive result on discografie in conformity with Isis Guidelines. [46]

Exclusion criteria

Exclusion criteria: o Modicse changes o pregnancy o Use of anticoagulantia o skin at the puncturespot. o Contrastallergy. o Psychiatric disorder o Solid bonefusion o Severe spinal stenoses at the treatment level. o Extrusions larger than 5mm o Spondylolisthesis level 2 or larger.

Design outcomes

Primary

MeasureTime frame
The goal for the pilot study is a minimal clinically relevant improvement of 1,5 points NRS en 2 points RMDQ, after 2 months. Based on the priliminary data from the USA the clinical expectance for the patients who receive PRP is for pain from 7 to 5 points NRS in 12 months and for functionality from 12 to 9 points RMDQ in 12 months. For patients in the control group the expectance is half a point NRS 7 to 6.5 and RMDQ from 12 to 11.

Secondary

MeasureTime frame
none

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)