Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain (SIlencing)

  • STATUS
    Recruiting
  • End date
    Apr 10, 2025
  • participants needed
    90
  • sponsor
    PD Dr. med. Simon Bayerl
Updated on 10 May 2022

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.

Details
Condition Sacroiliac Joint Pain
Treatment Peripheral Nerve Stimulation
Clinical Study IdentifierNCT05357300
SponsorPD Dr. med. Simon Bayerl
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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