Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain

NCT05357300 | Unknown DMC

• 1 other identifier: 128236
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroiliac Joint Pain

Keywords

Peripheral Nerve Stimulation; Back Pain; Sacroiliac Joint Pain; Neuromodulation; Persistent Spinal Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Peripheral Nerve Stimulation

ACTIVE COMPARATOR

Implant of percutaneous leads and impulse generator for peripheral nerve stimulation

Device: Peripheral Nerve Stimulation

Best Medical Treatment

NO INTERVENTION

Physical therapy and therapy with analgetic medication

Interventions

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

Peripheral Nerve Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• PD Dr. med. Simon Bayerl: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin, Department of Neurosurgery

Berlin, 12203, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 22151653 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.

  PMID: 12565774 BACKGROUND

• 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/

  PMID: 29763017 BACKGROUND

• 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.

  PMID: 38549128 DERIVED

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon H Bayerl, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Dimitri Tkatschenko, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Model Details: Evaluation of the pain reduction in patients treated with peripheral nerve stimulation compared to best medical treatment

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: April 26, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)