Table 3.
Estimated proportions of successful responders among patients who were treated by the decompression and adhesiolysis using an inflatable balloon catheter.
Follow-Up (Months) |
Below 50% (n = 48), Estimated Proportion (95% CI) |
50–85% (n = 79), Estimated Proportion (95% CI) |
85–100% (n = 148), Estimated Proportion (95% CI) |
p- Value | |
---|---|---|---|---|---|
Successful | 1 | 0.688 (0.556–0.819) | 0.633 (0.527–0.739) | 0.662 (0.586–0.738) | 0.812 |
Responder | 3 | 0.542 (0.401–0.683) | 0.582 (0.474–0.691) | 0.628 (0.551–0.706) | 0.528 |
6 | 0.292 (0.163–0.420) | 0.468 (0.358–0.578) | 0.507 (0.426–0.587) | 0.038 |
The patients were divided into groups of less than 50%, 50–85%, and 85–100% depending on the success rate of the ballooning procedure for multiple target sites. Successful response was defined as: 1) ≥50% (or ≥4-point) reduction from baseline leg NRS; and no increase from baseline ODI and MQS; and ≥4 points on the GPES scale; or 2) ≥30% (or ≥2-point) reduction from baseline NRS with any one of the following criteria; simultaneous ≥30% (or ≥10-point) reduction in ODI from baseline; or ≥5 points on the GPE scale; or no increase from the baseline MQS. A generalized estimating equation was used in the statistical analysis. Data are expressed as estimated proportions and 95% confidence interval (CI). GPES = global perceived effect of satisfaction; MQS = medication quantification scale; ODI = Oswestry disability index.