Sacroiliac Joint Pain
Conditions
Keywords
Peripheral Nerve Stimulation, Back Pain, Sacroiliac Joint Pain, Neuromodulation, Persistent Spinal Pain Syndrome
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.
Interventions
DEVICEPeripheral Nerve Stimulation
Implant of percutaneous leads for peripheral nerve stimulation of the rami dorsales of the SIJ and gluteal or abdominal implant of impulse generator
Sponsors
PD Dr. med. Simon Bayerl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Evaluation of the pain reduction in patients treated with peripheral nerve stimulation compared to best medical treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of chronic sacroiliac joint pain | 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 |
Countries
Germany
Contacts
Primary ContactSimon H Bayerl, MD
Backup ContactDimitri Tkatschenko, MD
Outcome results
None listed