Assessment of peripheral pro- and anti-neuroinflammatory cytokine changes in blood and saliva biofluids by enzyme-linked immune assay (ELISA) in neuropathic refractory post-surgical knee pain syndrome (CPSP) treated with dorsal root ganglion stimulation (SCS-DRG) and analysis of possible correlation between peripheral cytokine changes and DRG-associated pain and functional state (depression, sleep architecture, body weight) responsiveness

Not Applicable

Conditions: M79.66

Registration Number: DRKS00011267

Lead Sponsor: St. Jude Medical GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 24

Inclusion Criteria

Patients, with confirmed chronic postoperative knee pain (CPSP).
Not suitable for further surgical procedures in the knee Region.
Commitment for SCS-DRG System.
Unchanged medication 4 weeks before SCS-DRG Implantation.

Exclusion Criteria

-Other neurological disorders (traumatic brain injury)
-Substance abuse
-Neuropsychiatric Disorders,
-Pregnancy
-Cardiovascular diseases
-Not willing to provide follow-up
- Pregnancy

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Data capture of the baseline pain relief and after 3 and 12 months by means of the visual analog scale VAS.<br>Data capture baseline sleep behavior and after 3 and 12 months with questionnaire PSQI.<br>Data capture of intensity of depression Baseline, and after 3 and 12 months using the BDI questionnaire.<br>Laboratory data capture parameters Oxytocin and CGRP Baseline and after 3 and 12 months<br>Data capture of pain sensitivity by using the QST examination procedure.<br>Assessment of peripheral pro- and anti-neuroinflammatory cytokine changes in blood and saliva biofluids by enzyme-linked immune assay (ELISA).

Secondary Outcome Measures

Name	Time	Method
Detection of the changes in peripheral pro and anti-neuroinflammatory cytokines (IL-1 beta, IL-10, CGRP) caused by the stimulation of spinal ganglion (SCS-DRG) and the oxcytocin concentration in renitent CPSP patients.<br>Detection of a possible relationship between the peripheral pro- and anti-neuroinflammatory cytokine alterations of IL-1, IL-10, CGRP and oxcytocin with subjective pain perception after SCS-DRG treatment, measurement of pain sensitivity (QST) and the extent of improved functionalities BDI, PSQI, BMI)