Table 2.
Patient responses by treatment arm and measurement
| Baseline | Week-1 | Week-2 | Follow-Up-1 | Follow-Up-2 | ||
|---|---|---|---|---|---|---|
| Average Daily Pain | REAL | 5.60(1.85) | 4.90(1.89) | 3.99(1.90) | 4.19(1.90) | 4.41(1.95) |
| SHAM | 5.34(1.82) | 5.49(1.90) | 5.07(1.89) | 4.76(1.90) | 5.37(2.02) | |
| FIQ | REAL | 58.79(11.93) | 55.03(16.93) | 42.07(18.13) | 49.29(19.27) | 38.99(19.44) |
| SHAM | 54.38(13.96) | 51.22(15.96) | 51.50(17.32) | 43.47(16.10) | 47.93(14.70) | |
| HDRS | REAL | 21.80(7.79) | 17.30(8.27) | 16.10(8.19) | 15.80(8.74) | 14.10(9.42) |
| SHAM | 17.60(7.31) | 17.40(8.42) | 15.30(7.62) | 17.20(7.55) | 16.40(8.18) | |
| Tender Points | REAL | 13.20(2.53) | 11.40(3.60) | 9.44(4.53) | 10.33(5.79) | 10.40(4.77) |
| SHAM | 13.50(1.72) | 13.60(1.58) | 14.33(2.18) | 13.40(2.59) | 13.00(3.56) | |
| % ACR Criteria | REAL | 90% | 70% | 56% | 56% | 50% |
| SHAM | 100% | 100% | 100% | 80% | 70% | |
| BPI Functional Impairment | REAL | 5.57(2.58) | 4.66(2.72) | 3.46(2.19) | 4.08(2.23) | 3.60(2.18) |
| SHAM | 5.44(2.25) | 4.69(3.08) | 4.98(2.35) | 3.84(2.39) | 3.79(2.69) | |
The data represents mean scores and standard deviations for average daily pain, FIQ, HDRS, tender points, BPI, and percentage of patients that met ACR criteria for fibromyalgia during the five weekly assessments during the trial. ACR criteria tender points categorically require eleven of eighteen tender points for diagnosis.