Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Sacroiliac Joint Pain

Intervention / Treatment
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* Device: Peripheral Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Evaluation of the pain reduction in patients treated with peripheral nerve stimulation compared to best medical treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peripheral Nerve Stimulation<br>Implant of percutaneous leads and impulse generator for peripheral nerve stimulation | Device: Peripheral Nerve Stimulation<br>* Implant of percutaneous leads for peripheral nerve stimulation of the rami dorsales of the SIJ and gluteal or abdominal implant of impulse generator<br>|
| No Intervention: Best Medical Treatment<br>Physical therapy and therapy with analgetic medication | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Nerve Stimulation, Back Pain, Sacroiliac Joint Pain, Neuromodulation, Persistent Spinal Pain Syndrome