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

Study Timeline

• Study Start: 2022-04-26
• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-27
• Status Verified: 2022-05
• Study First Posted: 2022-05-02
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-06
• Primary Completion: 2025-04
• Study Completion: 2025-04

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

Name	Time	Method
Change of chronic sacroiliac joint pain	6 months	Change of pain measured with a numeric rating scale ranking from minimum 0 to maximum 100 where higher numbers mean a worse outcome

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin, Department of Neurosurgery; 🇩🇪 Berlin, Germany