Table A7:
Global Impression of Change and Treatment Satisfaction, SENZA-RCT Study
| 10-kHz High-Frequency SCS | Conventional SCS | Differencea | ||
|---|---|---|---|---|
| Global Impression of Change, % | ||||
| Baseline | No symptoms | 0.0 | 0.0 | 0 |
| Minimal symptoms | 6.7 | 9.9 | −3.2 | |
| Transient symptoms | 17.8 | 19.8 | −2.0 | |
| Mild symptoms | 37.8 | 35.8 | 2.0 | |
| Moderate symptoms | 26.7 | 27.2 | −0.5 | |
| Serious symptoms | 11.1 | 6.2 | 4.9 | |
| Some impairment | 0.0 | 1.2 | −1.2 | |
| 3 months | No symptoms | 6.7 | 4.9 | 1.8 |
| Minimal symptoms | 27.0 | 23.5 | 3.5 | |
| Transient symptoms | 27.0 | 22.2 | 4.8 | |
| Mild symptoms | 29.2 | 29.6 | −0.4 | |
| Moderate symptoms | 7.9 | 16.0 | −8.1 | |
| Serious symptoms | 1.1 | 3.7 | −2.6 | |
| Some impairment | 1.1 | 0.0 | 1.1 | |
| 6 months | No symptoms | 14.6 | 7.4 | 7.2 |
| Minimal symptoms | 28.1 | 27.2 | 0.9 | |
| Transient symptoms | 23.6 | 25.9 | −2.3 | |
| Mild symptoms | 24.7 | 24.7 | 0 | |
| Moderate symptoms | 6.7 | 12.3 | −5.6 | |
| Serious symptoms | 2.2 | 2.5 | −0.3 | |
| Some impairment | 0.0 | 0.0 | 0 | |
| 12 months | No symptoms | 19.1 | 13.6 | 5.5 |
| Minimal symptoms | 24.7 | 22.2 | 2.5 | |
| Transient symptoms | 27.0 | 23.5 | 3.5 | |
| Mild symptoms | 18.0 | 23.5 | −5.5 | |
| Moderate symptoms | 7.9 | 13.6 | −5.7 | |
| Serious symptoms | 3.4 | 3.7 | −0.3 | |
| Some impairment | 0.0 | 0.0 | 0 | |
| Global Impression of Change, Patient | ||||
| 12 months | Great deal better | 29.5 | 21.3 | 6.2 |
| Better | 27.3 | 16.3 | 11.0 | |
| Moderately better | 21.6 | 22.5 | −0.9 | |
| Somewhat better | 9.1 | 8.8 | 0.3 | |
| Little better | 4.5 | 8.8 | −4.3 | |
| Almost the same | 3.4 | 6.3 | −2.9 | |
| No change | 4.5 | 16.3 | −11.8 | |
| 24 months | Great deal better | 34.1 | 21.1 | 13.0 |
| Better | 29.4 | 15.5 | 13.9 | |
| Moderately better | 11.8 | 19.7 | −7.9 | |
| Somewhat better | 4.7 | 12.7 | −8.0 | |
| Little better | 2.4 | 5.6 | −3.2 | |
| Almost the same | 8.2 | 4.2 | 4.0 | |
| No change | 9.4 | 21.1 | −11.7 | |
| Global Impression of Change, Physician | ||||
| 12 months | Great deal better | 39.3 | 25.0 | 14.3 |
| Better | 34.8 | 25.0 | 9.8 | |
| Moderately better | 11.2 | 16.3 | −5.1 | |
| Somewhat better | 6.7 | 10.0 | −3.3 | |
| Little better | 0.0 | 3.8 | −3.8 | |
| Almost the same | 3.4 | 5.0 | −1.6 | |
| No change | 4.5 | 15 | −10.5 | |
| 24 months | Great deal better | 40.7 | 20.0 | 20.7 |
| Better | 27.9 | 28.6 | −0.7 | |
| Moderately better | 9.3 | 12.9 | −3.6 | |
| Somewhat better | 8.1 | 12.9 | −4.8 | |
| Little better | 2.3 | 1.4 | 0.9 | |
| Almost the same | 1.2 | 1.4 | −0.2 | |
| No change | 10.5 | 22.9 | −12.4 | |
| Patient Satisfaction, % | ||||
| 3 months | Very satisfied | 54.1 | 33.8 | 20.3 |
| Satisfied | 29.4 | 43.2 | −13.8 | |
| Not sure | 14.1 | 17.6 | −3.5 | |
| Dissatisfied | 1.2 | 2.7 | −1.5 | |
| Very dissatisfied | 1.2 | 2.7 | 1.5 | |
| 6 months | Very satisfied | NR | NR | — |
| Satisfied | NR | NR | — | |
| Not sure | NR | NR | — | |
| Dissatisfied | NR | NR | — | |
| Very dissatisfied | NR | NR | — | |
| 12 months | Very satisfied | 55.4 | 32.3 | 23.1 |
| Satisfied | 27.7 | 46.2 | −18.5 | |
| Not sure | 15.7 | 16.9 | −1.2 | |
| Dissatisfied | 1.2 | 3.1 | −1.9 | |
| Very dissatisfied | 0.0 | 1.5 | −1.5 | |
| 24 months | Very satisfied | 60.0 | 40.4 | 19.6 |
| Satisfied | 26.3 | 45.6 | −19.3 | |
| Not sure | 10.0 | 10.5 | −0.5 | |
| Dissatisfied | 1.3 | 3.5 | −2.2 | |
| Very dissatisfied | 0.0 | 0.0 | 0 | |
Abbreviation: SCS, spinal cord stimulation.
a
Crude differences calculated for this health technology assessment.
Source: Kapural et al, 2015.30