Pilot study to evaluate the safety and the effectiveness of the Neurolyser XR as a treatment for sacroiliitis
Pilot, Interventional, Prospective, Open label, Single Arm study to evaluate Non-invasive thermal ablation of the posterior sacral nerve branches as a treatment of painful sacroiliac joint (SIJ) using High Intensity Focused Ultrasound delivered by the Neurolyser XR. Patient would be treated and then followed for up to 6 months. Primary safety endpoint will be measured by the incidence and severity of treatment related adverse events Primary effectiveness endpoint will be measured by the changes in average pain score and Rolland Morris Disability Questionnaire between baseline and 6 and 12 months
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Using the NeurolyserXR to non-invasively ablate the posterior sacral branches enervating the sacroiliac joint
Sheba Medical Center
Giv‘atayim, Israel
RECRUITINGEffectiveness per pain score using numerical rating scale of 0 to 10
Pain reduction would be measured using numerical rating scale of 0 to 10 to evaluate pain and brief pain inventory questioner
Time frame: Baseline throughout the follow-up period of six months
Safety per adverse events
Measured by the incidence and severity of treatment related adverse events
Time frame: Baseline throughout the follow-up period of six months
Assess self-rated physical disability caused by low back pain
Roland-Morris Disability Questionnaire providing a scale of 0 to 24 when 0 is best and 24 is worst
Time frame: Baseline throughout the follow-up period of six months
Opioid intake dosage using morphine equivalency conversion
Using by recording patient opioid intake using opioid equivalency chart
Time frame: Baseline throughout the follow-up period of six months
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