Researching if the injection of PRP with patients suffering from discogenic low back problems with or without anular tear, without modic has significant beneficial effects on pain and functionality.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
discogene lage rugklachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
none
Background summary
The prevelance of discogenic low back problems is high and in 66 percent of the
patients,not treatable. Data from recent scientific research in the USA
suggests that there is a possible solution for these patients. The researched
intervention is injecting platelet rich plasma (PRP) in lumbar disci with an
intradiscal injection. The prilimary results from the USA show a significant
positive effect on pain and functionality.
Study objective
Researching if the injection of PRP with patients suffering from discogenic low
back problems with or without anular tear, without modic has significant
beneficial effects on pain and functionality.
Study design
We start with a feasability pilot study including 10 patients. After analyzing
and adapting the protocol we can start the RCT if the minimal results are
reached.
Double blind randomised controlled trial. The tested hypothesis is:
"An injection of 1cc PRP, taken en processed directly from the patient, in a
lumbal disc with or without anular tear, without modic, significantly improves
pain and functionality. "
The questionnaires used are the NRS (pain), Roland Morris (functionality) and
the SF-36 (self reported health). Patients have to fill out the questionnaires
7 times; before the injection (baseline), 1 and 4 weeks after the injection
(control of injection), and 2, 4, 6, and 12 months after the injection (data
gathering).
Study burden and risks
The risks of participating are very low, there is a small risk of infection,
bleeding and nerve damage because of the injection given in de disc. The burden
of participating is one checkup appointment (telephone/visit) and filling out
the questionnaires 7 times.
De Eiken 3
Delden 7491 HP
NL
De Eiken 3
Delden 7491 HP
NL
Listed location countries
Age
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.
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 |
|---|---|
| CCMO | NL46021.044.13 |