TWO-YEAR FOLLOW-UP OF A CONTROLLED TRIAL OF INTRADISCAL ELECTROTHERMAL ANULOPLASTY FOR CHRONIC LOW BACK PAIN DUE TO INTERNAL DISC DISRUPTION

Abstract

Introduction: On the basis of observational data, intradiscal electrothermal anuloplasty (IDETA) has been implemented as a treatment for back pain due to internal disc disruption. In order to assess the efficacy of IDETA, a prospective cohort study with comparison group was commenced in 1998. The present study provides the two-year results of that study.

Methods: Of 53 patients who satisfied the diagnostic criteria for internal disc disruption 36 were allocated to a treatment group and 17 to a comparison group, according to whether or not their insurer approved treatment with IDETA. Outcomes were assessed in terms of relief of pain, return to work, and use of opioids to treat persisting pain, at three months, twelve months, and two years after treatment.

Results: As a group, the comparison patients exhibited no significant improvement in their pain at any time. One was partially relieved, but no patient was completely relieved at either 12 or 24 months. The patients treated with IDETA exhibited significant improvements in their median pain scores, which were sustained at 12 and 24 months. At 24 months, 54% of these patients had achieved at least 50% relief of their pain, no longer used opioids, and were at work. Seven patients (20%) were totally free of pain and at work at 24 months.

Discussion: Despite the small sample size, the study had 90% power to detect the differences encountered at three months, 78% power at two years. The long-term results of IDETA are stable and enduring. It is not universally successful, but 54% of patients can reduce their pain by half, and one in five patients can expect to achieve complete relief of their pain. The results encountered in the present study are better than those reported in the literature, but may be attributed to more stringent selection of patients and closer attention to the accuracy of operative technique. Given the benchmark established by this study, consumers should beware of observational and controlled studies that achieve lesser results, lest these be used to impugn the procedure rather than the operator.