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

Peripheral Nerve Stimulation for Treatment of Chronic Therapy-refractory Sacroiliac Joint Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Sacroiliac Joint Pain
• Intervention / Treatment: Device: Peripheral Nerve Stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon H Bayerl, MD; Phone Number: +49 (0)30 450 560789; Email: simon.bayerl@charite.de
• Study Contact Backup: Name: Dimitri Tkatschenko, MD; Phone Number: +49 (0)30 450 560789; Email: dimitri.tkatschenko@charite.de

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • Charité - Universitätsmedizin Berlin, Department of Neurosurgery
    • Contact: Simon H Bayerl, MD; Phone Number: +49(0)30 450560789; Email: simon.bayerl@charite.de
    • Contact: Dimitri Tkatschenko, MD; Phone Number: +49(0)30 450560789; Email: dimitri.tkatschenko@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peripheral Nerve Stimulation; Implant of percutaneous leads and impulse generator for peripheral nerve stimulation	Device: 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
No Intervention: Best Medical Treatment; Physical therapy and therapy with analgetic medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: PD Dr. med. Simon Bayerl
• Investigators: Principal Investigator: Simon H Bayerl, MD, Charite University, Berlin, Germany; Principal Investigator: Dimitri Tkatschenko, MD, Charite University, Berlin, Germany

Publications and helpful links

General Publications

• 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. 2022 Jul 21. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499842/

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Neuromodulation; Peripheral Nerve Stimulation; Back Pain; Sacroiliac Joint Pain; Persistent Spinal Pain Syndrome
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia
• Other Study ID Numbers: 128236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No