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Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain

Not Applicable
Recruiting
Conditions
Sacroiliac Joint Pain
Registration Number
NCT05357300
Lead Sponsor
PD Dr. med. Simon Bayerl
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
90
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change of chronic sacroiliac joint pain6 months

Change of pain measured with a numeric rating scale ranking from minimum 0 to maximum 100 where higher numbers mean a worse outcome

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin, Department of Neurosurgery

🇩🇪

Berlin, Germany

Charité - Universitätsmedizin Berlin, Department of Neurosurgery
🇩🇪Berlin, Germany
Simon H Bayerl, MD
Contact
+49(0)30 450560789
simon.bayerl@charite.de
Dimitri Tkatschenko, MD
Contact
+49(0)30 450560789
dimitri.tkatschenko@charite.de

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