Table A8:
Health-Related Quality of Life and Sleep Quality, De Andres et al
| 10-kHz High-Frequency SCS | Conventional SCS | Differencea | |
|---|---|---|---|
| SF-12 Mean ± SD | |||
| Baseline | |||
| Physical functioning | 0.0 ± 0.00 | 13.79 ± 29.57 | — |
| Role physical | 14.42 ± 18.94 | 18.97 ± 21.81 | −4.55 |
| Bodily pain | 25.96 ± 20.59 | 20.69 ± 24.15 | −5.27 |
| General health | 18.27 ± 26.06 | 18.10 ± 17.55 | 0.17 |
| Vitality | 20.00 ± 18.76 | 22.07 ± 25.27 | −2.07 |
| Social functioning | 36.15 ± 29.40 | 51.03 ± 33.20 | −14.88 |
| Role emotional | 36.54 ± 48.08 | 41.38 ± 50.12 | −4.84 |
| Mental health | 42.69 ± 20.70 | 38.28 ± 24.79 | 4.41 |
| 12 Months | |||
| Physical functioning | 23.08 ± 40.57 | 18.75 ± 33.76 | 4.33 |
| Role physical | 28.37 ± 27.28 | 25.00 ± 28.87 | 3.37 |
| Bodily pain | 32.69 ± 27.17 | 37.50 ± 32.98 | −4.81 |
| General health | 26.92 ± 6.38 | 38.39 ± 22.03 | −11.47 |
| Vitality | 26.15 ± 26.39 | 27.14 ± 33.65 | −0.99 |
| Social functioning | 51.15 ± 29.44 | 53.93 ± 32.58 | −2.78 |
| Role emotional | 50.00 ± 50.99 | 54.46 ± 48.14 | −4.46 |
| Mental health | 48.46 ± 24.77 | 49.64 ± 24.26 | −1.18 |
| HAD, Anxiety, Mean ± SD | |||
| Baseline | 10.31 ± 4.03 | 10.72 ± 4.60 | −0.41 |
| 3 months | 7.46 ± 4.12 | 8.07 ± 4.54 | −0.61 |
| 6 months | 8.35 ± 5.18 | 8.24 ± 5.37 | 0.11 |
| 12 months | 8.69 ± 5.08 | 8.54 ± 5.67 | 0.15 |
| Mean change, 12 months to baseline | 1.62 | 2.18 | — |
| HAD, Depression, Mean ± SD | |||
| Baseline | 8.96 ± 4.04 | 9.45 ± 4.31 | −0.49 |
| 3 months | 5.69 ± 3.51 | 6.34 ± 4.05 | −0.65 |
| 6 months | 6.69 ± 4.86 | 7.03 ± 5.52 | −0.34 |
| 12 months | 8.19 ± 5.00 | 7.21 ± 4.97 | 0.98 |
| Mean change, 12 months to baseline | 0.77 | 2.20 | — |
| MOS-SS, Mean ± SD | |||
| Somnolence | |||
| Baseline | 51.79 ± 23.04 | 53.10 ± 28.87 | −1.31 |
| 6 months | 58.21 ± 24.19 | 62.99 ± 18.05 | −4.78 |
| 12 months | 67.18 ± 19.95 | 63.10 ± 24.98 | 4.08 |
| Mean change, 12 months to baseline | −15.4 | −10.0 | — |
| Sleep Disturbance | |||
| Baseline | 29.66 ± 25.13 | 27.20 ± 25.24 | −2.46 |
| 6 months | 45.82 ± 29.56 | 39.31 ± 24.98 | 6.51 |
| 12 months | 41.25 ± 25.95 | 37.32 ± 29.71 | 3.93 |
| Mean change, 12 months to baseline | −11.59 | −10.12 | — |
| Sleep Quantity | |||
| Baseline | 5.25 ± 1.17 | 5.03 ± 1.37 | 0.22 |
| 6 months | 5.79 ± 1.54 | 5.57 ± 1.29 | 0.22 |
| 12 months | 5.73 ± 1.11 | 5.48 ± 1.54 | 0.25 |
| Mean change, 12 months to baseline | −0.48 | −0.45 | — |
| Awake, Short of Breath | |||
| Baseline | 57.69 ± 31.15 | 57.93 ± 34.37 | −0.24 |
| 6 months | 73.85 ± 24.50 | 68.28 ± 31.86 | 5.57 |
| 12 months | 76.92 ± 29.77 | 65.00 ± 31.09 | 14.92 |
| Mean change, 12 months to baseline | −19.23 | −7.07 | — |
| Snoring | |||
| Baseline | 43.08 ± 38.65 | 34.48 ± 36.12 | 8.6 |
| 6 months | 51.54 ± 38.02 | 45.52 ± 36.99 | 6.02 |
| 12 months | 51.54 ± 41.63 | 41.43 ± 35.25 | 10.11 |
| Mean change, 12 months to baseline | −8.46 | −6.95 | — |
| Sleep Adequacy | |||
| Baseline | 27.42 ± 24.51 | 31.03 ± 26.23 | −3.61 |
| 6 months | 46.92 ± 32.59 | 42.07 ± 33.21 | 4.85 |
| 12 months | 40.00 ± 29.53 | 37.86 ± 32.01 | 2.14 |
| Mean change, 12 months to baseline | −12.58 | −6.83 | — |
Abbreviation: HAD, Hospital Anxiety and Depression; MOS-SS, Medical Outcomes Study Sleep Scale; SCS, spinal cord stimulation; SD, standard deviation; SF-12, SF-12 health-related quality of life questionnaire.
a
Crude differences calculated for this health technology assessment.
Source: De Andres et al, 2017.29