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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral Nerve Stimulation | Active Comparator | Implant of percutaneous leads and impulse generator for peripheral nerve stimulation |
|
| Best Medical Treatment | No Intervention | Physical therapy and therapy with analgetic medication |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral Nerve Stimulation | Device | Implant of percutaneous leads for peripheral nerve stimulation of the rami dorsales of the SIJ and gluteal or abdominal implant of impulse generator |
| Measure | Description | Time Frame |
|---|---|---|
| Change of chronic sacroiliac joint pain | Change of pain measured with a numeric rating scale ranking from minimum 0 to maximum 100 where higher numbers mean a worse outcome | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simon H Bayerl, MD | Contact | +49 (0)30 450 560789 | simon.bayerl@charite.de | |
| Dimitri Tkatschenko, MD | Contact | +49 (0)30 450 560789 | dimitri.tkatschenko@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Simon H Bayerl, MD | Charite University, Berlin, Germany | Principal Investigator |
| Dimitri Tkatschenko, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin, Department of Neurosurgery | Recruiting | Berlin | 12203 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22151653 | Background | 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. | |
| 12565774 | Background | 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. |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Evaluation of the pain reduction in patients treated with peripheral nerve stimulation compared to best medical treatment
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| 29763017 | Background | Al Khalili Y, Jain S, Lam JC, DeCastro A. Brachial Neuritis. 2024 Feb 2. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499842/ |
| 38549128 | Derived | 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. |