Intradiscal electrothermal annuloplasty therapy: a case series study leading to new considerations.

OBJECTIVE

To evaluate outcomes of intradiscal electrothermal annuloplasty (IDEA) therapy in the treatment of chronic discogenic low back pain in consecutive IDEA patients treated at a rural pain management clinic.

STUDY DESIGN

An observational case series study design was applied to consecutive IDEA patients qualifying under the inclusion and exclusion criteria. Patient assessment of pain and disability were performed at baseline and 6 weeks, 3, 6, 12, and 24 months post-IDEA.

METHODS

Selected patients underwent IDEA for an average of 15 minutes at a temperature of 90 degrees C. Analyses of outcomes included Visual Analog Scale (VAS) assessments of levels of pain, and Roland Morris Disability Questionnaire (RMDQ) assessments of functional capacity at pretreatment, and 6 weeks, 3, 6, 12, and 18 months post-treatment time points.

RESULTS

At 6 months post-IDEA treatment, patients (n=51) demonstrated statistically significant improvement (P < 0.001) as measured by a mean change of over 20 points from the pretreatment score on the RMDQ. At 1 year, post data remained significant in the 33 patients who had achieved this time point. VAS pain data were also statistically significant at 6 months (P = 0.023). Analysis of patient profiles revealed that statistically significant improvement of pain and functional capacity was strongly associated with female gender and age (range of 18-45 years), and that statistically significant improvement was not sustained in males beyond the 3-6 month point. These data support the outcomes reported in the few existing observational studies to date. Of 86 patients receiving IDEA therapy, 73 provided RMDQ data at baseline and at 3 months or later and were included in the analyses. Some patients were lost to follow-up at later time points.

CONCLUSIONS

These data show favorable outcomes after IDEA therapy, and suggest that women may experience more improvement than men, particularly with regard to perceived disability improvements. Data suggest that greater improvement in IDEA outcomes may be achieved by profiling the characteristics of patients who achieve the optimal long-term outcomes following treatment and should be considered during evaluation of patient eligibility for IDEA.