A factor analysis of lumbar intradiscal electrothermal annuloplasty outcomes.

BACKGROUND CONTEXT

Intradiscal electrothermal annuloplasty (IDET) is a minimally invasive procedure for managing chronic discogenic low back pain (LBP). Although there have been numerous reports of IDET outcome rates, few have dissected the detailed factors affecting those outcomes.

PURPOSE

To evaluate how heating variables and the number of catheters used affect the outcomes and pain flare-up in LBP patients treated with IDET.

STUDY DESIGN/SETTING: Retrospective analysis.

PATIENT SAMPLE

Data were gathered on the basis of chart records from January 6, 1999 to January 6, 2000. Twenty-five cases treated at a single level with disc protrusion < or = 2 mm, nonfocal neurological abnormalities, and positive discogram with annular tear were studied. Six patients were unavailable for follow-up at 16 months.

OUTCOME MEASURES

All assessments were incorporated into our own evaluation sheet, completed before the procedure and at follow-up. Assessments included the following: 1) Visual Analog Scale (VAS) and 2) Back Pain Improvement Scales (BPI) preoperatively and at 8 and 16 months post-procedure. Post-procedure flare-up of the pain was defined as the pain aggravation after the IDET procedure from the pre-procedure baseline pain. It was evaluated by a 10-point numeric rating scale, ranging from no aggravated pain "0" to the worst aggravated pain "10".

METHODS

Patients were partitioned into a single-catheter group and a double-catheter group. In these two groups, statistical analyses were done to compare the outcomes and flare-up duration and intensity. In each catheter group, the correlation coefficients were analyzed between heating variables such as heating duration/temperature and two outcome scales. Then, two outcome scales relative to intensity and duration of post-IDET flare-up were analyzed with Pearson's correlation. Also the combined effect of the heating duration and temperature was evaluated as a thermal dosage, which is the total amount of heat developed during the procedure. It was calculated by multiplying the temperature and its heating duration above a starting temperature of 65 degrees C.

RESULTS

Comparing the single- and double-catheter groups, patients placed in the single-catheter group showed significantly shorter flare-up duration (11.00+/-19.17 vs. 24.89+/-20.84 days, p < .05). In the single-catheter group, the flare-up duration manifested moderate linear correlation with heating variables (0.580 with temperature, 0.519 with thermal dosage, p < .05). Also, the improvements of pain with VAS displayed moderate reverse correlation with heating variables at 8 months (-.436 with temperature, -0.439 with thermal dosage, p < .1). In the double-catheter group, the Back Pain Improvement% had strong reverse correlations with temperature and thermal dosage at 8 months (-.735 and -.729, p < .05). The correlation between the improvement of VAS and temperature yielded a moderate reverse relationship (-.619, p < 0.1). These correlations were not, however, observed at 16 months in either the single- or double-catheter groups.

CONCLUSIONS

Higher temperatures and larger total heating doses during IDET procedures with catheters placed in the outer annulus may increase the duration of post-procedure pain flare-ups and lead to less favorable outcomes at 8 months follow-up. The long-term outcomes at 16 months may, however, not be affected by these heating variables.