Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain
NCT ID: NCT05357300
Last Updated: 2022-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2022-04-26
2025-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peripheral Nerve Stimulation
Implant of percutaneous leads and impulse generator for peripheral nerve stimulation
Peripheral Nerve Stimulation
Implant of percutaneous leads for peripheral nerve stimulation of the rami dorsales of the SIJ and gluteal or abdominal implant of impulse generator
Best Medical Treatment
Physical therapy and therapy with analgetic medication
No interventions assigned to this group
Interventions
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Peripheral Nerve Stimulation
Implant of percutaneous leads for peripheral nerve stimulation of the rami dorsales of the SIJ and gluteal or abdominal implant of impulse generator
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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PD Dr. med. Simon Bayerl
OTHER
Responsible Party
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PD Dr. med. Simon Bayerl
PD Dr. med.
Principal Investigators
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Simon H Bayerl, MD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Dimitri Tkatschenko, MD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Charité - Universitätsmedizin Berlin, Department of Neurosurgery
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Stinson LW Jr, Roderer GT, Cross NE, Davis BE. Peripheral Subcutaneous Electrostimulation for Control of Intractable Post-operative Inguinal Pain: A Case Report Series. Neuromodulation. 2001 Jul;4(3):99-104. doi: 10.1046/j.1525-1403.2001.00099.x.
van Balken MR, Vandoninck V, Messelink BJ, Vergunst H, Heesakkers JP, Debruyne FM, Bemelmans BL. Percutaneous tibial nerve stimulation as neuromodulative treatment of chronic pelvic pain. Eur Urol. 2003 Feb;43(2):158-63; discussion 163. doi: 10.1016/s0302-2838(02)00552-3.
Al Khalili Y, Jain S, Lam JC, DeCastro A. Brachial Neuritis. 2024 Feb 2. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499842/
Sargut TA, Tkatschenko D, Fruh A, Tuttenberg J, Heckert A, Fleck S, Kuckuck A, Bayerl SH. Study protocol for a prospective, randomized, multicenter trial to investigate the influence of peripheral nerve stimulation on patients with chronic sacroiliac joint syndrome (SILENCING). Trials. 2024 Mar 28;25(1):223. doi: 10.1186/s13063-024-08067-z.
Other Identifiers
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128236
Identifier Type: -
Identifier Source: org_study_id
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