SIlencing: Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain

• Sponsor: PD Dr. med. Simon Bayerl (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05357300
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35.2
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sacroiliac Joint Pain	Device: Peripheral Nerve Stimulation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Evaluation of the pain reduction in patients treated with peripheral nerve stimulation compared to best medical treatmentEvaluation of the pain reduction in patients treated with peripheral nerve stimulation compared to best medical treatment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Peripheral Nerve Stimulation for Treatment of Chronic Therapy-refractory Sacroiliac Joint Pain
• Actual Study Start Date: Apr 26, 2022
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité - Universitätsmedizin Berlin, Department of Neurosurgery	Berlin		Germany	12203

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Al Khalili Y, Jain S, Lam JC, DeCastro A. Brachial Neuritis. 2022 Jul 21. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499842/
• 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.

• Responsible Party: PD Dr. med. Simon Bayerl, PD Dr. med., Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT05357300
• Other Study ID Numbers: 128236
• First Posted: May 2, 2022
• Last Update Posted: May 6, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by PD Dr. med. Simon Bayerl, PD Dr. med., Charite University, Berlin, Germany: Peripheral Nerve Stimulation; Back Pain; Sacroiliac Joint Pain; Neuromodulation; Persistent Spinal Pain Syndrome
• Additional relevant MeSH terms: Arthralgia

Study Results

No Results Posted as of May 6, 2022