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

Primary Purpose

Sacroiliac Joint Pain

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Peripheral Nerve Stimulation
Sponsored by
PD Dr. med. Simon Bayerl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacroiliac Joint Pain focused on measuring Peripheral Nerve Stimulation, Back Pain, Sacroiliac Joint Pain, Neuromodulation, Persistent Spinal Pain Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Charité - Universitätsmedizin Berlin, Department of NeurosurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Peripheral Nerve Stimulation

Best Medical Treatment

Arm Description

Implant of percutaneous leads and impulse generator for peripheral nerve stimulation

Physical therapy and therapy with analgetic medication

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 26, 2022
Last Updated
May 2, 2022
Sponsor
PD Dr. med. Simon Bayerl
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1. Study Identification

Unique Protocol Identification Number
NCT05357300
Brief Title
Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain
Acronym
SIlencing
Official Title
Peripheral Nerve Stimulation for Treatment of Chronic Therapy-refractory Sacroiliac Joint Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
PD Dr. med. Simon Bayerl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Pain
Keywords
Peripheral Nerve Stimulation, Back Pain, Sacroiliac Joint Pain, Neuromodulation, Persistent Spinal Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Evaluation of the pain reduction in patients treated with peripheral nerve stimulation compared to best medical treatment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peripheral Nerve Stimulation
Arm Type
Active Comparator
Arm Description
Implant of percutaneous leads and impulse generator for peripheral nerve stimulation
Arm Title
Best Medical Treatment
Arm Type
No Intervention
Arm Description
Physical therapy and therapy with analgetic medication
Intervention Type
Device
Intervention Name(s)
Peripheral Nerve Stimulation
Intervention Description
Implant of percutaneous leads for peripheral nerve stimulation of the rami dorsales of the SIJ and gluteal or abdominal implant of impulse generator
Primary Outcome Measure Information:
Title
Change of chronic sacroiliac joint pain
Description
Change of pain measured with a numeric rating scale ranking from minimum 0 to maximum 100 where higher numbers mean a worse outcome
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon H Bayerl, MD
Phone
+49 (0)30 450 560789
Email
simon.bayerl@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitri Tkatschenko, MD
Phone
+49 (0)30 450 560789
Email
dimitri.tkatschenko@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon H Bayerl, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dimitri Tkatschenko, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Universitätsmedizin Berlin, Department of Neurosurgery
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon H Bayerl, MD
Phone
+49(0)30 450560789
Email
simon.bayerl@charite.de
First Name & Middle Initial & Last Name & Degree
Dimitri Tkatschenko, MD
Phone
+49(0)30 450560789
Email
dimitri.tkatschenko@charite.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22151653
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.
Results Reference
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PubMed Identifier
12565774
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. doi: 10.1016/s0302-2838(02)00552-3.
Results Reference
background
PubMed Identifier
29763017
Citation
Al Khalili Y, Jain S, Lam JC, DeCastro A. Brachial Neuritis. 2023 Mar 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499842/
Results Reference
background

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Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain

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