Sacroiliac Joint PainSIlencingNCT05357300
Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain
A study testing Peripheral Nerve Stimulation in people with Sacroiliac Joint Pain, run by PD Dr. med. Simon Bayerl at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliac Joint Pain
- What is being tested?
- Peripheral Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 26 Apr 2022to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin, Department of Neurosurgery
Berlin, 12203
Simon H Bayerl, MD, +49(0)30 450560789, simon.bayerl@charite.de
Dimitri Tkatschenko, MD, +49(0)30 450560789, dimitri.tkatschenko@charite.de
About this study
Official title: 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.
- Conditions
- Sacroiliac Joint Pain
- Being tested
- Peripheral Nerve Stimulation
- Keywords
- Peripheral Nerve Stimulation, Back Pain, Sacroiliac Joint Pain, Neuromodulation, Persistent Spinal Pain Syndrome
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Nerve StimulationDevice
Implant of percutaneous leads for peripheral nerve stimulation of the rami dorsales of the SIJ and gluteal or abdominal implant of impulse generator
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Nerve Stimulation | Active comparator | Implant of percutaneous leads and impulse generator for peripheral nerve stimulation Receives: Device: Peripheral Nerve Stimulation |
| Best Medical Treatment | No intervention | Physical therapy and therapy with analgetic medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start26 Apr 2022
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sacroiliac Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Evaluation of the pain reduction in patients treated with peripheral nerve stimulation compared to best medical treatment
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PD Dr. med. Simon Bayerl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, PD Dr. med. Simon Bayerl, Charite University, Berlin, Germany
- Investigators
- Simon H Bayerl, MD, Principal investigator, Charite University, Berlin, GermanyDimitri Tkatschenko, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357300
- Sponsor's protocol ID
- 128236
- Acronym
- SIlencing
- Status last verified
- May 2022
- First submitted
- 26 Apr 2022
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22151653van 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.
PubMed 12565774Al Khalili Y, Jain S, Lam JC, DeCastro A. Brachial Neuritis. 2024 Feb 2. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499842/
PubMed 29763017Sargut 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.
PubMed 38549128
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Stimulation for Treatment of Chronic Therapy-refractory Sacroiliac Joint Pain
- ClinicalTrials.gov ID
- NCT05357300
- Acronym / sponsor ID
- SIlencing / 128236
- Conditions
- Sacroiliac Joint Pain
- Keywords
- Peripheral Nerve Stimulation, Back Pain, Sacroiliac Joint Pain, Neuromodulation, Persistent Spinal Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- PD Dr. med. Simon BayerlUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Evaluation of the pain reduction in patients treated with peripheral nerve stimulation compared to best medical treatment
| Arm | Type | Receives |
|---|---|---|
| Peripheral Nerve Stimulation | Active comparator | Device: Peripheral Nerve StimulationImplant of percutaneous leads and impulse generator for peripheral nerve stimulation |
| Best Medical Treatment | No intervention | –Physical therapy and therapy with analgetic medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnancy
- Subject is under age
- Acute traumatic injury of the ISG
- Active inflammation or neoplastic infiltration of the SIJ
- Neoplastic diseases of the spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral Nerve StimulationImplant of percutaneous leads for peripheral nerve stimulation of the rami dorsales of the SIJ and gluteal or abdominal implant of impulse generator | Device | Peripheral Nerve Stimulation |
Primary outcome
Change of chronic sacroiliac joint pain
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Background: PubMed 22151653Stinson 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.
- Background: PubMed 12565774van 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.
- Background: PubMed 29763017Al Khalili Y, Jain S, Lam JC, DeCastro A. Brachial Neuritis. 2024 Feb 2. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499842/
- Derived from this study: PubMed 38549128Sargut 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.
- Individual participant dataSharing planned: No
Related trials for Sacroiliac Joint Pain
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruitingObservational study
Does Injection Target Matter in Sacroiliac Joint Dysfunction?
Sacroiliac Joint Dysfunction, Multifidus
RecruitingEarly Phase 1
Ketorolac Versus Corticosteroid Injections for Sacroiliac Joint Pain
Sacro-iliac Joint Pain
Enrolling by invitationObservational study
Sacroiliac Joint Fusion Intervention For Mobility, Pain Relief, and Lasting Improvement in Functional Recovery "SIMPLIFY"
Degenerative Sacroiliitis, Sacroiliac Disorder
Not yet recruiting
Postural Correction and Lumbar Stabilization vs MET for Postpartum Pain
Postpartum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon H Bayerl, MD principal investigator
Charite University, Berlin, Germany
Dimitri Tkatschenko, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral Nerve Stimulation in people with Sacroiliac Joint Pain, run by PD Dr. med. Simon Bayerl at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon H Bayerl, MD (+49 (0)30 450 560789, simon.bayerl@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of chronic sacroiliac joint pain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05357300, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.