Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain

Sacroiliac Joint Pain Clinical Trial

— SIlencing  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357300
• Other study ID #: 128236
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: April 2025

Study information

• Verified date: May 2022
• Source: Charite University, Berlin, Germany
• Contact: Simon H Bayerl, MD
• Phone: +49 (0)30 450 560789
• Email: simon.bayerl[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthralgia
• Sacroiliac Joint Pain

Intervention

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

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin, Department of Neurosurgery	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
PD Dr. med. Simon Bayerl

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Al Khalili Y, Jain S, Lam JC, DeCastro A. Brachial Neuritis. 2022 Jan 20. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499842/ — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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