Peripheral Nerve Stimulation for Treatment of Chronic Therapy-refractory Sacroiliac Joint Pain

PD Dr. med. Simon Bayerl1 site in 1 country90 target enrollmentApril 26, 2022

ConditionsSacroiliac Joint Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sacroiliac Joint Pain
Sponsor: PD Dr. med. Simon Bayerl
Enrollment: 90
Locations: 1
Primary Endpoint: Change of chronic sacroiliac joint pain
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Prospective randomized controlled study, primary objective: Pain reduction in patients with chronic Sacroiliac joint pain after therapy either with Peripheral Nerve Stimulation or with best medical treatment.

Randomization 4:3 to operative (PNS=Peripheral Nerve Stimulation) arm or conservative (BMT= Best Medical Treatment) arm with crossover possibility for the BMT group after 6 months.

Registry

clinicaltrials.gov

Start Date

April 26, 2022

End Date

April 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

PD Dr. med. Simon Bayerl

Responsible Party

Sponsor Investigator

Principal Investigator

PD Dr. med. Simon Bayerl

PD Dr. med.

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

•Subject is at least 18 years old
•Subject with chronic sacroiliac joint pain refractory to conservative treatment
•Subject with NRS of at least 60/100
•Subject with temporary pain reduction of at least 50% (NRS) after fluoroscopy guided SIJ infiltration
•Subject received conservative treatment for at least three months including physiotherapy and pain medication
•Subject is able to understand the study and Impulse generator programming

Exclusion Criteria

•Pregnancy
•Subject is under age
•Acute traumatic injury of the ISG
•Active inflammation or neoplastic infiltration of the SIJ
•Neoplastic diseases of the spine
•Spinal surgery within the last three months
•The SIJ pain is not the leading symptom
•Contraindication for Neuromodulation Device (severe psychiatric disease, severe coagulation disorder, acute infection, active autoimmune disease with immunosupression)