PRP injections in disci

Recruiting

• Conditions: discogene lage rugklachten; discus degeneration; low back pain

• Registration Number: NL-OMON44855
• Lead Sponsor: Stichting Rugpoli

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 96

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

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>none</p><br>