RFN for SIJ Disease Study

Inclusion Criteria

• •1. Written, informed consent
• •2. Age: 18 - 80 years old
• •3. Low back pain of more than 6 months duration with a minimum pain intensity of greater than 5 out of 10 on an 11-point numerical rating scale in the 7 days preceding study entry.
• •4. Subjects must achieve greater than 80% reduction in pain following each diagnostic, intra-articular block. Subjects must undergo 2 blocks in total prior to randomisation.
• •5. Female subjects of potential childbearing age must be using adequate contraception (i.e. using oral or intramuscular contraception or an IUCD) and must have a negative urine test.
• •6. No vulnerable patient groups shall be recruited into this study
• •2. Subjects who have previously been treated by any sacroiliac joint radiofrequency neurotomy
• •3. Subjects who are breastfeeding
• •4. Contraindications to local anaesthetics and radiofrequency neurotomy as listed in their respective summary of product characteristics
• •5. Subjects with documented or suspected alcohol or drug abuse, or who are suspected of having an addictive personality
• •6. Subjects to whom any of the following apply: Major trauma to the lumbar spine in the six months preceding study entry. Infection in the lumbar spine in the six months preceding study entry
• •7. Subjects' known to have a condition that, in the investigator's judgment precludes entry into the study.
• •8. Subjects with a significant psychiatric disorder (including depression) or subjects receiving anti-psychotic medication.
• •9. Subjects who have received an investigational drug or have used an investigational device in the 30 days preceding study entry.
• •10. Subjects unable to comply with the study assessments or unable to complete the questionnaires.