M25.56
Conditions
Interventions
Group 1: Patients with chronic therapy-refractory knee pain after receiving a knee endoprosthesis with already implanted DRG stimulation
Group 2: Patients with chronic therapy-refractory knee pain bef
Sponsors
Klinik und Poliklinik für Neurochirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age > 18 years, ability to consent, compliance, chronic pain symptoms in the knee: > 3 months duration, intermittently several times a week or permanent pain, insufficient improvement through conservative therapy, associated: subj. suffering, functional impairment, reduced quality of life. Knee TKP performed or indicated. Group according to TKR: TKR received according to S2k guideline, exclusion of mechanical cause by means of knee X-ray, if necessary CT/ MRI/ sono, exclusion of infection (normal CRP, unremarkable knee inspection). Group before TKA: Indication according to S2k guideline, TKA not yet performed. Group DRG stimulation: > 3 months after knee TEP, successfully completed test phase (pain reduction VAS > 50%), definitive pulse generator implanted. Group without DRG stimulation: DRG stimulation indicated, DRG stimulation not performed without patient request, contraindications (coagulation disorder; oral anticoagulation that cannot be paused/platelet function inhibitors; chronic wound healing disorders, lumbar infection, ASS > 3, incompatible pacemaker/incompatible deep brain stimulation system)
Exclusion criteria
Exclusion criteria: Age < 18 years, lack of capacity to consent, lack of compliance, substance abuse (drugs, alcohol), already implanted active or ineffective SCS/DRG system due to other indication, acute severe psychiatric illness requiring treatment, incompatible pacemaker, incompatible system for deep brain stimulation, knee infection: increased CRP , clinical signs at knee inspection. Treatable mechanical cause after TKA (detection in the X-ray image, if necessary CT/MRT/sonography, pathologies of the lumbar spine or in adjacent joints (hip, ankle) with pain radiating into the knee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients with chronic therapy-refractory knee pain before/after receiving a knee endoprosthesis benefit from neurostimulation using DRG stimulation compared to a control group without neuromodulatory stimulation. Pain reduction >50% by visual analogue scale compared to baseline. Pain intensity is assessed after 1 month, 3 months, 6 months, 12 months and 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Influence of the stimulation effect on quality of life, depression and functional limitations after one month, 3 months, 6 months, 12 months and 24 months. | — |
Countries
Germany
Contacts
Public ContactFranziska Frank
Klinik und Poliklinik für Neurochirurgie
Outcome results
None listed