Identification of inflammatory mediators in spinal liquor in relation to synovial nerve sprouting and pain in osteoarthritis

Completed

Conditions: osteoarthitis
10023213

Registration Number: NL-OMON46137

Lead Sponsor: TI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 42

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet the following criteria:;* At least 18 years of age
* In regular practice eligible for surgery under spinal anesthesia for
o knee joint replacement as treatment for knee OA
o A knee VAS pain score (on a scale of 100) either lower than 40 or higher than 60.
* Able and willing to give written informed consent

Exclusion Criteria

Other (auto) immune disease or diabetes mellitus.
Use of (pain) medication other than NSAIDS

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cytokines and chemokines and growthfactors in spinal cerebral fluid measured<br /><br>by LUMINEX.<br /><br>- Patients will be selected based on the clinical parameter knee pain VAS<br /><br>(visual analog scale) specifically for the affected knee.<br /><br><br /><br>The primary outcome is a normally distributed continuous variable and will be<br /><br>the the level of inflammatory mediators in the spinal cerebral fluid. Knee OA<br /><br>patients will be selected either of having severe pain , defined by as knee<br /><br>VAS>60 or limited clinical pain (knee VAS<40).<br /><br>We will determine an broad panel of cytokine/chemokines and growth factors (up<br /><br>to 100) with validated assays and available at the LUMINEX core facilities of<br /><br>the laboratory of translational immunology. The panel will at least include,<br /><br>IL1, TNF, IL6, IL10, IL4, IL13, TGF, IL17, VEGF, CCL2, CXCL4, BDNF, NGF,<br /><br>Cathepsin S, M-CSF, IL34, GFAP, S100</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To asses different aspects of pain we will include additional pain<br /><br>questionnaires. These include:<br /><br>- Intermittent and constant osteoarthritis pain (ICOAP).<br /><br>-The Knee injury and Osteoarthritis Outcome Score (KOOS) score to dichotomize<br /><br>the knee OA patients.<br /><br>- PAINDETECT questionnaire<br /><br><br /><br><br /><br>We will also evaluate differences in the following determinants:<br /><br><br /><br>2. nerve innervation of the synovium measured by immunohistochemistry of<br /><br>tyrosine hydroxylase (sympathetic nerves) and PGP9.5 (sensory neurons).<br /><br>3. nerve innervation of the subchondrial junction measured.</p><br>