Table 2.
Pre- and post-treatment measures for blinded and open-label phases
| Blinded phase |
Open-label phase |
|||||
|---|---|---|---|---|---|---|
| Active group n = 45 |
Sham group n = 55 |
Sham group n = 40 |
||||
| Pre | Post | Pre | Post | Pre | Post | |
| Pre–post pain measures (mean ± SD) | ||||||
| BPI pain intensity subscale | 23.9 ± 5.5 | 21.6 ± 6.6 | 23.4 ± 6.0 | 20.8 ± 6.7 | 21.8 ± 6.0** | 20.8 ± 5.9** |
| BPI pain interference subscale* | 56.2 ± 21.7*** | 39.5 ± 24.3*** | 38.5 ± 27.3*** | 32.2 ± 23.8*† | 31.6 ± 23.9 | 28.1 ± 23.7 |
| 36-item short-form health survey (SF-36) pain subscale* | 36.0 ± 17.8 | 41.4 ± 16.6 | 44.9 ± 17.1 | 52.5 ± 18.6 | 51.3 ± 20.2 | 49.3 ± 18.9 |
| PQAS paroxysmal pain subscale | 5.6 ± 2.0 | 4.5 ± 2.1 | 4.9 ± 1.9 | 4.3 ± 2.2 | 4.2 ± 2.1 | 4.1 ± 2.0 |
| PQAS surface pain subscale | 4.1 ± 2.5 | 3.6 ± 2.1 | 3.4 ± 2.0 | 3.4 ± 2.0 | 3.5 ± 1.9 | 3.4 ± 1.7 |
| PQAS deep pain subscale | 4.5 ± 2.5 | 3.8 ± 2.3 | 3.8 ± 2.3 | 3.4 ± 2.3 | 3.3 ± 2.3 | 3.5 ± 2.2 |
| Two-item measures of pain beliefs and coping strategies maladaptive coping subscale* | 37.4 ± 11.7 | 30.6 ± 13.5 | 29.5 ± 13.1 | 26.6 ± 14.3 | 26.6 ± 14.4 | 25.6 ± 13.2 |
| Two-item measures of pain beliefs and coping strategies adaptive coping subscale | 30.2 ± 11.3 | 28.9 ± 10.2 | 29.2 ± 12.5 | 30.0 ± 12.0 | 30.8 ± 9.7 | 32.6 ± 9.0 |
| Pre–post health measures (mean ± SD) | ||||||
| 12-item short-form health survey (SF-12) physical component summary (PCS) | 28.7 ± 20.5 | 27.8 ± 21.6 | 34.5 ± 23.4 | 33.6 ± 20.7 | 35.7 ± 23.5 | 37.5 ± 25.9 |
| 12-item short-form health survey (SF-12) mental component summary (MCS)* | 55.3 ± 26.5 | 59.1 ± 24.1 | 67.5 ± 22.5 | 66.2 ± 23.7 | 64.3 ± 24.7 | 63.7 ± 25.5 |
| 10-item center for epidemiologic studies depression scale (CES-D-10)* | 13.4 ± 6.9 | 11.9 ± 6.9 | 10.2 ± 6.0 | 9.9 ± 6.0 | 9.8 ± 6.1 | 9.3 ± 5.8 |
| 10-item perceived stress scale (PSS-10) | 16.4 ± 7.4 | 13.9 ± 6.9 | 14.0 ± 7.4 | 13.0 ± 7.6 | 12.9 ± 7.5 | 12.3 ± 7.6 |
| 6-item short-form state-trait anxiety inventory (SF-STAI-6)* | 11.2 ± 4.2 | 11.1 ± 4.0 | 9.2 ± 3.8 | 9.4 ± 3.6 | 9.2 ± 4.0 | 9.8 ± 4.3 |
*Measures on which active and sham groups were significantly different at pre-treatment in the blinded phase.
Within-group paired t-tests: **P ≤ 0.05, ***P ≤ 0.001, *†P ≤ 0.01.
Note: Lower scores are better in all measures except those from the SF-36 and SF-12.