Table 4.
Mean Changes in Efficacy Measures from Baseline to 3-Months Using a MMRM Analysis
| Measure | N | Mean Change | SE | Treatment Comparison (Active - Sham) |
||
|---|---|---|---|---|---|---|
| Difference | 95% CI | p-value | ||||
| FIQR Total Score | ||||||
| Sham | 57 | −6.02† | 1.81 | |||
| Active | 62 | −13.49‡ | 1.69 | −7.47 | −12.46, −2.48 | 0.003 |
| FIQR Pain Item | ||||||
| Sham | 57 | −1.21‡ | 0.20 | |||
| Active | 62 | −1.83‡ | 0.19 | −0.62 | −1.17, −0.06 | 0.029 |
| FIQR Sleep Quality Item | ||||||
| Sham | 57 | −0.55 | 0.31 | |||
| Active | 62 | −1.59‡ | 0.28 | −1.04 | −1.87, −0.20 | 0.015 |
| BPI Severity | ||||||
| Sham | 57 | −0.89‡ | 0.17 | |||
| Active | 62 | −1.19‡ | 0.16 | −0.40 | −0.87, 0.08 | 0.102 |
| BPI Interference | ||||||
| Sham | 57 | −1.14‡ | 0.22 | |||
| Active | 62 | −1.84‡ | 0.20 | −0.70 | −1.30, −0.11 | 0.021 |
| PDQ | ||||||
| Sham | 57 | 0.06 | 0.56 | |||
| Active | 62 | −1.63† | 0.51 | −1.69 | −3.20, −0.18 | 0.028 |
| PDI | ||||||
| Sham | 57 | −3.43† | 1.25 | |||
| Active | 62 | −6.07‡ | 1.11 | −2.64 | −5.99, 0.70 | 0.121 |
| HADS | ||||||
| Sham | 57 | −1.01† | 0.51 | |||
| Active | 62 | −1.82‡ | 0.49 | −0.81 | −2.22, 0.60 | 0.259 |
| PCS | ||||||
| Sham | 57 | −3.53‡ | 0.86 | |||
| Active | 62 | −3.39‡ | 0.78 | 0.15 | −2.17, 2.46 | 0.902 |
Notes: †Significant within group improvement at p<0.05; ‡Significant within group improvement at p<0.001.
Abbreviations: MMRM, mixed-model for repeated measures; SE, standard error; CI, confidence interval; FIQR, Fibromyalgia Impact Questionnaire Revised; BPI, Brief Pain Inventory; PDQ, painDETECT questionnaire; PDI, Pain Disability Index; HADS, Hospital Anxiety and Disability Scale; PCS, Pain Catastrophizing Scale.