Clinical trial NCT05357300: Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain
Official title: Peripheral Nerve Stimulation for Treatment of Chronic Therapy-refractory Sacroiliac Joint Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sacroiliac Joint Pain
Keywords: Peripheral Nerve Stimulation
Back Pain
Sacroiliac Joint Pain
Neuromodulation
Persistent Spinal Pain Syndrome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluation of the pain reduction in patients treated with peripheral nerve stimulation compared to best medical treatment
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change of chronic sacroiliac joint pain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Department of Neurosurgery
Study officials:
affiliation: Charite University, Berlin, Germany
name: Simon H Bayerl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Dimitri Tkatschenko, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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/