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

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 - neuropathic refractory post-surgical knee pain syndrome (CPSP)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011267

Enrollment

Registered

2016-11-11

Start date

2016-11-21

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

M79.66

Interventions

Group 1: Study of minimally invasive spinal ganglion stimulation in 15 patients with therapy-refractory chronic postoperative knee pain (CPSP). Subjective assessments for the measurement of the VAS, B

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
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. 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)	—

Measure

Time frame

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. 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)

—

Countries

Germany

Contacts

Public ContactThomas M. Kinfe

Klinik für Psychiatrie, Abteilung für Medizinische Psychologie

thomas.kinfe@ukb.uni-bonn.de+49 (0)228 287 - 19105

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 2, 2026